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Last Updated: April 25, 2025

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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United States: These 39 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "United States: These 39 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can CERIANNA (fluoroestradiol f-18) generic drug versions launch?

Generic name: fluoroestradiol f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 20, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

CERIANNA is a drug marketed by Ge Healthcare.

The generic ingredient in CERIANNA is fluoroestradiol f-18. One supplier is listed for this generic product. Additional details are available on the fluoroestradiol f-18 profile page.

When can ABLYSINOL (alcohol) generic drug versions launch?

Generic name: alcohol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 21, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

ABLYSINOL is a drug marketed by Bpi Labs.

The generic ingredient in ABLYSINOL is alcohol. There are forty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the alcohol profile page.

When can VYLEESI (AUTOINJECTOR) (bremelanotide acetate) generic drug versions launch?

Generic name: bremelanotide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2025
Generic Entry Controlled by: United States Patent Patent 6,794,489

VYLEESI (AUTOINJECTOR) is a drug marketed by Cosette. There are five patents protecting this drug.

This drug has eighty-one patent family members in twenty-six countries.

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. One supplier is listed for this generic product. Additional details are available on the bremelanotide acetate profile page.

When can TROXYCA ER (naltrexone hydrochloride; oxycodone hydrochloride) generic drug versions launch?

Generic name: naltrexone hydrochloride; oxycodone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 03, 2025
Generic Entry Controlled by: United States Patent Patent 8,685,443

TROXYCA ER is a drug marketed by Pfizer. There are two patents protecting this drug.

This drug has sixteen patent family members in twelve countries.

The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this API. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.

When can KRINTAFEL (tafenoquine succinate) generic drug versions launch?

Generic name: tafenoquine succinate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 20, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

KRINTAFEL is a drug marketed by Glaxosmithkline.

This drug has sixteen patent family members in twelve countries.

See drug price trends for KRINTAFEL.

The generic ingredient in KRINTAFEL is tafenoquine succinate. Two suppliers are listed for this generic product. Additional details are available on the tafenoquine succinate profile page.

When can KYZATREX (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 27, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

KYZATREX is a drug marketed by Marius Pharms Llc. There are four patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has twenty patent family members in eleven countries.

See drug price trends for KYZATREX.

The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can OMEGAVEN (fish oil triglycerides) generic drug versions launch?

Generic name: fish oil triglycerides
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 27, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

OMEGAVEN is a drug marketed by Fresenius Kabi Usa. There are two patents protecting this drug.

This drug has five patent family members in four countries. There has been litigation on patents covering OMEGAVEN

See drug price trends for OMEGAVEN.

The generic ingredient in OMEGAVEN is fish oil triglycerides. There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the fish oil triglycerides profile page.

When can AZEDRA (iobenguane i-131) generic drug versions launch?

Generic name: iobenguane i-131
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 30, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

AZEDRA is a drug marketed by Progenics Pharms Inc.

This drug has five patent family members in four countries.

See drug price trends for AZEDRA.

The generic ingredient in AZEDRA is iobenguane i-131. Additional details are available on the iobenguane i-131 profile page.

When can GALAFOLD (migalastat hydrochloride) generic drug versions launch?

Generic name: migalastat hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GALAFOLD is a drug marketed by Amicus Therap Us. There are sixty-two patents protecting this drug.

This drug has two hundred and fifty-two patent family members in thirty countries. There has been litigation on patents covering GALAFOLD

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this generic product. Additional details are available on the migalastat hydrochloride profile page.

When can FEMTRACE (estradiol acetate) generic drug versions launch?

Generic name: estradiol acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 02, 2025
Generic Entry Controlled by: United States Patent Patent 7,572,779

FEMTRACE is a drug marketed by Apil. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the estradiol acetate profile page.

When can EDURANT (rilpivirine hydrochloride) generic drug versions launch?

Generic name: rilpivirine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 21, 2025
Generic Entry Controlled by: United States Patent Patent 7,125,879

Drug Price Trends for EDURANT
EDURANT is a drug marketed by Janssen Prods. There are three patents protecting this drug.

This drug has one hundred and ninety-nine patent family members in forty-two countries. There has been litigation on patents covering EDURANT

See drug price trends for EDURANT.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the rilpivirine hydrochloride profile page.

When can GALLIUM GA 68 PSMA-11 (gallium ga-68 psma-11) generic drug versions launch?

Generic name: gallium ga-68 psma-11
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GALLIUM GA 68 PSMA-11 is a drug marketed by

This drug has one hundred and ninety-nine patent family members in forty-two countries.

The generic ingredient in GALLIUM GA 68 PSMA-11 is gallium ga-68 psma-11. There are sixteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the gallium ga-68 psma-11 profile page.

When can NEVANAC (nepafenac) generic drug versions launch?

Generic name: nepafenac
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 02, 2025
Generic Entry Controlled by: United States Patent Patent 8,071,648

Drug Price Trends for NEVANAC
NEVANAC is a drug marketed by Harrow Eye. There are three patents protecting this drug.

This drug has twenty-seven patent family members in twenty-three countries.

See drug price trends for NEVANAC.

The generic ingredient in NEVANAC is nepafenac. There are eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the nepafenac profile page.

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 19, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

This drug has fifty-four patent family members in twenty-eight countries. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this generic product. Additional details are available on the abaloparatide profile page.

When can NUCYNTA ER (tapentadol hydrochloride) generic drug versions launch?

Generic name: tapentadol hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 27, 2025
Generic Entry Controlled by: United States Patent Patent 7,994,364

Drug Price Trends for NUCYNTA ER
NUCYNTA ER is a drug marketed by Collegium Pharm Inc. There are three patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has ninety-six patent family members in twenty-seven countries. There has been litigation on patents covering NUCYNTA ER

See drug price trends for NUCYNTA ER.

The generic ingredient in NUCYNTA ER is tapentadol hydrochloride. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the tapentadol hydrochloride profile page.

When can AIRSUPRA (albuterol sulfate; budesonide) generic drug versions launch?

Generic name: albuterol sulfate; budesonide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 10, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for AIRSUPRA
AIRSUPRA is a drug marketed by Astrazeneca. There is one patent protecting this drug.

This drug has one hundred and eighty-four patent family members in thirty-one countries.

See drug price trends for AIRSUPRA.

The generic ingredient in AIRSUPRA is albuterol sulfate; budesonide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the albuterol sulfate; budesonide profile page.

When can SOLUPREP (chlorhexidine gluconate; isopropyl alcohol) generic drug versions launch?

Generic name: chlorhexidine gluconate; isopropyl alcohol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 20, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

SOLUPREP is a drug marketed by 3m Health Care.

This drug has one hundred and eighty-four patent family members in thirty-one countries.

The generic ingredient in SOLUPREP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

When can LUPKYNIS (voclosporin) generic drug versions launch?

Generic name: voclosporin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 22, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

LUPKYNIS is a drug marketed by Aurinia. There are three patents protecting this drug.

This drug has one hundred and ninety-six patent family members in forty countries. There has been litigation on patents covering LUPKYNIS

See drug price trends for LUPKYNIS.

The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the voclosporin profile page.

When can OTREXUP (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: United States Patent Patent 9,629,959

Drug Price Trends for OTREXUP
OTREXUP is a drug marketed by Otter Pharms. There are fourteen patents protecting this drug.

This drug has thirty-nine patent family members in fourteen countries. There has been litigation on patents covering OTREXUP

See drug price trends for OTREXUP.

The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

When can MYFEMBREE (estradiol; norethindrone acetate; relugolix) generic drug versions launch?

Generic name: estradiol; norethindrone acetate; relugolix
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 28, 2026
Generic Entry Controlled by: United States Patent Patent 7,300,935

Drug Price Trends for MYFEMBREE
MYFEMBREE is a drug marketed by Sumitomo Pharma. There are six patents protecting this drug.

This drug has one hundred and forty-five patent family members in thirty-five countries.

See drug price trends for MYFEMBREE.

The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.

When can EGATEN (triclabendazole) generic drug versions launch?

Generic name: triclabendazole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

EGATEN is a drug marketed by Novartis.

This drug has one hundred and forty-five patent family members in thirty-five countries.

The generic ingredient in EGATEN is triclabendazole. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the triclabendazole profile page.

When can SAXENDA (liraglutide recombinant) generic drug versions launch?

Generic name: liraglutide recombinant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: United States Patent Patent 8,114,833

Drug Price Trends for SAXENDA
SAXENDA is a drug marketed by Novo. There are eighteen patents protecting this drug.

This drug has one hundred and sixty-six patent family members in twenty-nine countries. There has been litigation on patents covering SAXENDA

See drug price trends for SAXENDA.

The generic ingredient in SAXENDA is liraglutide recombinant. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the liraglutide recombinant profile page.

When can VICTOZA (liraglutide recombinant) generic drug versions launch?

Generic name: liraglutide recombinant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: United States Patent Patent 8,114,833

Drug Price Trends for VICTOZA
VICTOZA is a drug marketed by Novo Nordisk Inc. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-nine countries. There has been litigation on patents covering VICTOZA

See drug price trends for VICTOZA.

The generic ingredient in VICTOZA is liraglutide recombinant. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the liraglutide recombinant profile page.

When can ARNUITY ELLIPTA (fluticasone furoate) generic drug versions launch?

Generic name: fluticasone furoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 01, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for ARNUITY ELLIPTA
ARNUITY ELLIPTA is a drug marketed by Glaxosmithkline. There are three patents protecting this drug.

This drug has forty-six patent family members in twenty-one countries. There has been litigation on patents covering ARNUITY ELLIPTA

See drug price trends for ARNUITY ELLIPTA.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the fluticasone furoate profile page.

When can VALCHLOR (mechlorethamine hydrochloride) generic drug versions launch?

Generic name: mechlorethamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 07, 2026
Generic Entry Controlled by: United States Patent Patent 7,838,564

VALCHLOR is a drug marketed by Helsinn. There are six patents protecting this drug.

This drug has fifty patent family members in twenty countries.

See drug price trends for VALCHLOR.

The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the mechlorethamine hydrochloride profile page.

When can FOTIVDA (tivozanib hydrochloride) generic drug versions launch?

Generic name: tivozanib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 10, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

FOTIVDA is a drug marketed by Aveo Pharms. There are three patents protecting this drug.

This drug has fifty-five patent family members in twenty-six countries.

See drug price trends for FOTIVDA.

The generic ingredient in FOTIVDA is tivozanib hydrochloride. One supplier is listed for this generic product. Additional details are available on the tivozanib hydrochloride profile page.

When can JATENZO (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 14, 2026
Generic Entry Controlled by: United States Patent Patent 11,179,402

Drug Price Trends for JATENZO
JATENZO is a drug marketed by Tolmar. There are ten patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has twenty-nine patent family members in fourteen countries. There has been litigation on patents covering JATENZO

See drug price trends for JATENZO.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can NEXTSTELLIS (drospirenone; estetrol) generic drug versions launch?

Generic name: drospirenone; estetrol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 15, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for NEXTSTELLIS
NEXTSTELLIS is a drug marketed by Mayne Pharma. There are five patents protecting this drug.

This drug has two hundred and ten patent family members in forty-eight countries.

See drug price trends for NEXTSTELLIS.

The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the drospirenone; estetrol profile page.

When can AURYXIA (ferric citrate) generic drug versions launch?

Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: United States Patent Patent 8,093,423

Drug Price Trends for AURYXIA
AURYXIA is a drug marketed by Keryx Biopharms. There are three patents protecting this drug.

This drug has one hundred and twenty-two patent family members in twenty-three countries. There has been litigation on patents covering AURYXIA

See drug price trends for AURYXIA.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the ferric citrate profile page.

When can VOCABRIA (cabotegravir sodium) generic drug versions launch?

Generic name: cabotegravir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2026
Generic Entry Controlled by: United States Patent Patent 8,410,103

VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this generic product. Additional details are available on the cabotegravir sodium profile page.

When can VYNDAQEL (tafamidis meglumine) generic drug versions launch?

Generic name: tafamidis meglumine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

VYNDAQEL is a drug marketed by Foldrx Pharms. There are two patents protecting this drug.

This drug has thirty-five patent family members in seventeen countries. There has been litigation on patents covering VYNDAQEL

See drug price trends for VYNDAQEL.

The generic ingredient in VYNDAQEL is tafamidis meglumine. One supplier is listed for this generic product. Additional details are available on the tafamidis meglumine profile page.

When can MYDCOMBI (phenylephrine hydrochloride; tropicamide) generic drug versions launch?

Generic name: phenylephrine hydrochloride; tropicamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 05, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

MYDCOMBI is a drug marketed by Eyenovia. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this API. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

When can RUZURGI (amifampridine) generic drug versions launch?

Generic name: amifampridine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 06, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

RUZURGI is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has forty-four patent family members in fourteen countries.

See drug price trends for RUZURGI.

The generic ingredient in RUZURGI is amifampridine. Additional details are available on the amifampridine profile page.

When can NATAZIA (dienogest; estradiol valerate) generic drug versions launch?

Generic name: dienogest; estradiol valerate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2026
Generic Entry Controlled by: United States Patent Patent 8,071,577

Drug Price Trends for NATAZIA
NATAZIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has ninety patent family members in thirty-nine countries. There has been litigation on patents covering NATAZIA

See drug price trends for NATAZIA.

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the dienogest; estradiol valerate profile page.

When can GATTEX KIT (teduglutide recombinant) generic drug versions launch?

Generic name: teduglutide recombinant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GATTEX KIT is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in seven countries. There has been litigation on patents covering GATTEX KIT

The generic ingredient in GATTEX KIT is teduglutide recombinant. There is one drug master file entry for this API. Two suppliers are listed for this generic product. Additional details are available on the teduglutide recombinant profile page.

When can INJECTAFER (ferric carboxymaltose) generic drug versions launch?

Generic name: ferric carboxymaltose
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

INJECTAFER is a drug marketed by Am Regent. There are six patents protecting this drug.

This drug has seventy-one patent family members in thirty-two countries. There has been litigation on patents covering INJECTAFER

See drug price trends for INJECTAFER.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ferric carboxymaltose profile page.

When can OMONTYS (peginesatide acetate) generic drug versions launch?

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2026
Generic Entry Controlled by: United States Patent Patent 7,550,433

OMONTYS is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has twenty-seven patent family members in eighteen countries.

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

When can SUFLAVE (magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate) generic drug versions launch?

Generic name: magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

SUFLAVE is a drug marketed by Braintree Labs. There is one patent protecting this drug.

This drug has one patent family member in one country.

See drug price trends for SUFLAVE.

The generic ingredient in SUFLAVE is magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate profile page.

When can SUPPRELIN LA (histrelin acetate) generic drug versions launch?

Generic name: histrelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: United States Patent Patent 8,062,652

SUPPRELIN LA is a drug marketed by Endo Operations. There is one patent protecting this drug.

This drug has three patent family members in three countries.

See drug price trends for SUPPRELIN LA.

The generic ingredient in SUPPRELIN LA is histrelin acetate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the histrelin acetate profile page.

United States Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges

The United States pharmaceutical market remains a global leader in both innovation and accessibility, with branded and generic drugs playing complementary roles in healthcare delivery. Branded pharmaceuticals, driven by breakthroughs in biologics, gene therapies, and personalized medicine, dominate revenue share (66.86% in 2024)[8], while generics ensure affordability, accounting for 90% of prescriptions filled[14]. The branded sector is projected to grow at a 5.72% CAGR to $883.97 billion by 2030[8], whereas generics face divergent growth forecasts—3.5% CAGR to $188.44 billion[1] versus 6.68% CAGR to $196.79 billion[3]—reflecting uncertainties in patent expirations and regulatory reforms. Regulatory challenges, including overseas manufacturing quality control[9], patent evergreening[7], and Risk Evaluation and Mitigation Strategy (REMS) abuses[12], intersect with opportunities like biosimilar adoption[3], FDA’s Competitive Generic Therapy (CGT) designations[15], and legislative proposals to enhance ingredient transparency[13].


Market Dynamics of Branded and Generic Pharmaceuticals

Growth Trajectories and Economic Impact

The U.S. branded drug market, valued at $634.32 billion in 2024, thrives on innovation in oncology, immunology, and obesity therapeutics. GLP-1 agonists like semaglutide have redefined obesity treatment, achieving 25% weight loss in trials[8], while CAR-T cell therapies exemplify precision medicine’s potential[8]. Conversely, generics, though smaller in revenue ($117.32 billion in 2023), provide critical cost savings, with prices 80–85% lower than brands[14]. Discrepancies in growth projections—3.5%[1] versus 6.68%[3]—stem from variable assumptions about biosimilar adoption and FDA’s efficiency in approving complex generics.

Therapeutic Area Dominance

Branded drugs lead in chronic disease management, with 68% of 2022 FDA novel approvals targeting first-in-class therapies[4]. Generics dominate acute and infectious disease treatments, but face hurdles in complex formulations like inhalers and injectables. The Mark Cuban Cost Plus Drug Company’s entry into sterile generics (e.g., norepinephrine) highlights efforts to address ICU drug shortages[3].


Regulatory Landscape: Balancing Innovation and Access

Branded Drug Exclusivity and Patent Strategies

Brand manufacturers leverage secondary patents and REMS to extend market control. For example, 33% of foreign generic manufacturing plants lacked FDA inspection as of 2015[9], enabling brands to argue quality disparities. The FDA’s 2025 legislative proposal mandates full ingredient disclosure to thwart "patent thicketing," where brands obscure inactive components to delay generic bioequivalence testing[13].

Generic Drug Approval Pathways

The Hatch-Waxman Act’s framework is strained by biosimilar complexities and REMS misuse. Brands often withhold drug samples under REMS, forcing generics into costly litigation[14]. FDA’s 2017 Competitive Generic Therapy (CGT) designation grants 180-day exclusivity for first generics in uncompetitive markets, accelerating launches for 14 products by 2023[15]. However, shared REMS systems remain underutilized due to brand resistance[16].


Opportunities in Evolving Markets

Branded Biologics and Personalized Medicine

Biologics, representing 40% of pipeline drugs[8], face imminent patent expirations, creating a $300 billion revenue risk by 2033[11]. Companies like AbbVie and Pfizer are pivoting to next-gen immunotherapies and RNA-based treatments to offset losses[8]. The FDA’s 2025 priority includes 70 novel approvals, with cell/gene therapies targeting rare diseases[10].

Generic Biosimilars and Complex Formulations

Biosimilars, projected to save $54 billion by 2029[17], are hindered by clinician hesitancy. FDA’s GDUFA III initiatives fund research into in vitro bioequivalence models for inhalers and injectables, aiming to halve approval times[17]. Meanwhile, Mark Cuban’s $11 million sterile drug facility exemplifies private-sector responses to supply chain fragility[3].


Persistent Challenges and Strategic Mitigations

Branded Drug Pricing and Legislative Pressures

The Inflation Reduction Act’s Medicare price negotiations, targeting 10 high-cost drugs in 2026, threaten branded margins[8]. Companies counter via accelerated approval pathways—76% of 2023 novel drugs received first-cycle FDA approval[4]—and indication-specific pricing models.

Generic Market Volatility and Anticompetitive Practices

Price erosion (average 50% post-generic entry[14]) and distributor consolidation strain manufacturers. FTC’s crackdown on reverse-payment settlements has saved consumers $24 billion annually since 2020[7]. Proposed solutions include futures markets to stabilize pricing and VA stockpiles to buffer shortages[7].


Future Outlook and Regulatory Reforms

FDA’s 2025 Agenda: Transparency and Global Alignment

The FDA’s FY 2025 proposals mandate real-time supply chain disclosures for drugs and medical devices, enhancing resilience[13]. International collaboration, like mutual recognition of generic approvals with the EMA, could streamline global submissions[7].

Balancing Innovation Incentives and Public Health

While branded firms invest $200 billion annually in R&D[8], generics require subsidies for complex manufacturing. The FDA’s draft guidance on quantitative bioequivalence for transdermal patches[17] and ingredient transparency rules[13] signal progress, yet sustained political will is critical to prevent backsliding.


Key Takeaways

  • Branded drugs will continue leading revenue through biologics and orphan drugs, but face patent cliffs and pricing reforms.
  • Generics’ growth hinges on overcoming REMS abuses and mastering complex formulations via regulatory science.
  • FDA’s 2025 agenda prioritizes supply chain resilience and global harmonization, but requires industry cooperation.

FAQs

  1. How do REMS programs affect generic drug approval?
    REMS can block generics by restricting access to brand samples for bioequivalence testing, though FDA now mandates shared systems[16].

  2. What drives the branded sector’s 5.72% CAGR despite patent losses?
    Pipeline innovation in obesity and oncology drugs offsets revenue declines, with 55 novel approvals in 2023[4][8].

  3. Are biosimilars as effective as branded biologics?
    Yes; FDA requires biosimilars to match efficacy/safety profiles, though clinician adoption remains slow[17].

  4. How does the Inflation Reduction Act impact drug pricing?
    It allows Medicare to negotiate prices for select high-cost drugs, starting with 10 in 2026, potentially reducing branded revenues[8].

  5. What are “competitive generic therapies”?
    CGTs receive 180-day exclusivity for being first-to-market in areas with no generics, incentivizing production of underserved drugs[15].

"The future of U.S. pharmaceuticals lies in balancing innovation incentives with policies that ensure generics remain a viable safety net." [17]

References

  1. https://www.biospace.com/u-s-generic-drugs-market-size-to-surpass-usd-188-44-bn-by-2032
  2. https://www.researchandmarkets.com/report/united-states-generics-market
  3. https://www.marketsandata.com/industry-reports/united-states-generic-drugs-market
  4. https://www.pharmexec.com/view/challenges-navigating-regulatory-landscape
  5. https://www.druganddevicelawblog.com/2023/02/generic-drugs-remain-generic-drugs-even-when-brand-name-drugs-leave-the-market.html
  6. https://www.biospace.com/press-releases/u-s-pharmaceutical-market-size-to-hit-usd-1-107-4-billion-by-2034
  7. https://www.drugpatentwatch.com/blog/addressing-generic-drug-market-challenges-strategies-for-stability-and-affordability/
  8. https://www.grandviewresearch.com/industry-analysis/us-pharmaceuticals-market-report
  9. https://www.drugpatentwatch.com/blog/how-to-manage-regulatory-challenges-in-generic-drugs/
  10. https://www.labiotech.eu/best-biotech/first-in-class-drugs-to-watch-2025/
  11. https://www.ibisworld.com/united-states/industry/brand-name-pharmaceutical-manufacturing/487/
  12. https://www.brookings.edu/articles/ten-challenges-in-the-prescription-drug-market-and-ten-solutions/
  13. https://www.fda.gov/media/176924/download
  14. https://www.pharmtech.com/view/opportunities-and-obstacles-generic-drugs-0
  15. https://www.theregreview.org/2020/04/22/fritz-encouraging-competition-generic-drugs/
  16. https://www.dcatvci.org/features/us-generics-market-opportunities-and-challenges/
  17. https://www.usp.org/sites/default/files/usp/document/ea83b_complex-generics_wp_2023-07_v3.pdf

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