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Last Updated: December 28, 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 42 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "United States: These 42 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 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 ninety-two patent family members in thirty-two countries. There has been litigation on patents covering AIRSUPRA

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 ninety-two patent family members in thirty-two countries.

The generic ingredient in SOLUPREP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this API. Five 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-eight 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 Assertio Speclty. There are fifteen 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 Am. There are seven patents protecting this drug.

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

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 fifty-six patent family members in thirty-six 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 two patents protecting this drug.

This drug has sixty-three patent family members in twenty-seven 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 two patents protecting this drug and one Paragraph IV challenge.

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

This drug has sixty-three patent family members in twenty-seven 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. Four 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. There has been litigation on patents covering FOTIVDA

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. Five 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 seven patents protecting this drug.

This drug has two hundred and twenty-nine patent family members in fifty-one 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 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 are three patents 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.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: United States Patent Patent 7,241,805

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries. There has been litigation on patents covering APLENZIN

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. 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 bupropion hydrobromide profile page.

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

Generic name: tapentadol hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 03, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

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

This drug has forty-five patent family members in twenty-six countries. There has been litigation on patents covering NUCYNTA

See drug price trends for NUCYNTA.

The generic ingredient in NUCYNTA 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 VALTURNA (aliskiren hemifumarate; valsartan) generic drug versions launch?

Generic name: aliskiren hemifumarate; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 03, 2026
Generic Entry Controlled by: United States Patent Patent 8,168,616

VALTURNA is a drug marketed by Novartis. There is one patent protecting this drug.

This drug has ninety-three patent family members in thirty-one countries.

The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; valsartan profile page.

When can OPILL (norgestrel) generic drug versions launch?

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

Drug Price Trends for OPILL
OPILL is a drug marketed by Laboratoire Hra.

This drug has ninety-three patent family members in thirty-one countries.

See drug price trends for OPILL.

The generic ingredient in OPILL is norgestrel. There are twenty-five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the norgestrel profile page.

When can GALLIUM DOTATOC GA 68 (gallium dotatoc ga-68) generic drug versions launch?

Generic name: gallium dotatoc ga-68
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

GALLIUM DOTATOC GA 68 is a drug marketed by

This drug has ninety-three patent family members in thirty-one countries.

The generic ingredient in GALLIUM DOTATOC GA 68 is gallium dotatoc ga-68. There are sixteen drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the gallium dotatoc ga-68 profile page.

When can TECHNEGAS KIT (technetium tc-99m labeled carbon) generic drug versions launch?

Generic name: technetium tc-99m labeled carbon
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

TECHNEGAS KIT is a drug marketed by Cyclomedica.

This drug has ninety-three patent family members in thirty-one countries.

The generic ingredient in TECHNEGAS KIT is technetium tc-99m labeled carbon. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the technetium tc-99m labeled carbon profile page.

When can VEREGEN (sinecatechins) generic drug versions launch?

Generic name: sinecatechins
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 02, 2026
Generic Entry Controlled by: United States Patent Patent 5,795,911

Drug Price Trends for VEREGEN
VEREGEN is a drug marketed by Ani Pharms. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty countries. There has been litigation on patents covering VEREGEN

See drug price trends for VEREGEN.

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

When can SCENESSE (afamelanotide) generic drug versions launch?

Generic name: afamelanotide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 08, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

SCENESSE is a drug marketed by Clivunel Inc. There are two patents protecting this drug.

This drug has thirty-four patent family members in eighteen countries.

See drug price trends for SCENESSE.

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

When can JUVISYNC (simvastatin; sitagliptin phosphate) generic drug versions launch?

Generic name: simvastatin; sitagliptin phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 11, 2026
Generic Entry Controlled by: United States Patent Patent 7,326,708

JUVISYNC is a drug marketed by Merck Sharp Dohme. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has fifty-two patent family members in forty countries. There has been litigation on patents covering JUVISYNC

The generic ingredient in JUVISYNC is simvastatin; sitagliptin phosphate. There are forty drug master file entries for this API. Additional details are available on the simvastatin; sitagliptin phosphate profile page.

When can COMBOGESIC IV (acetaminophen; ibuprofen sodium) generic drug versions launch?

Generic name: acetaminophen; ibuprofen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

COMBOGESIC IV is a drug marketed by Hikma. There are six patents protecting this drug.

This drug has seventy patent family members in thirty-one countries.

The generic ingredient in COMBOGESIC IV is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the acetaminophen; ibuprofen sodium profile page.

When can ADASUVE (loxapine) generic drug versions launch?

Generic name: loxapine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 23, 2026
Generic Entry Controlled by: United States Patent Patent 8,387,612

ADASUVE is a drug marketed by Alexza Pharms. There is one patent protecting this drug.

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

See drug price trends for ADASUVE.

The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this API. Additional details are available on the loxapine profile page.

When can SYNRIBO (omacetaxine mepesuccinate) generic drug versions launch?

Generic name: omacetaxine mepesuccinate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: United States Patent Patent 6,987,103

SYNRIBO is a drug marketed by Teva Pharms Intl. There is one patent protecting this drug and one Paragraph IV challenge.

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

See drug price trends for SYNRIBO.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this API. Additional details are available on the omacetaxine mepesuccinate profile page.

When can AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: United States Patent Patent 10,010,632

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries. There has been litigation on patents covering AXUMIN

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

When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: United States Patent Patent 9,763,953

ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.

This drug has twenty-six patent family members in seventeen countries. There has been litigation on patents covering ZUNVEYL

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

When can CORLANOR (ivabradine) generic drug versions launch?

Generic name: ivabradine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: United States Patent Patent 7,867,996

Drug Price Trends for CORLANOR
CORLANOR is a drug marketed by Amgen Inc. There are eight patents protecting this drug.

This drug has ninety-seven patent family members in forty-two countries. There has been litigation on patents covering CORLANOR

See drug price trends for CORLANOR.

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

When can VYONDYS 53 (golodirsen) generic drug versions launch?

Generic name: golodirsen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

VYONDYS 53 is a drug marketed by Sarepta Theraps Inc. There are eight patents protecting this drug.

This drug has thirty patent family members in thirteen countries. There has been litigation on patents covering VYONDYS 53

The generic ingredient in VYONDYS 53 is golodirsen. One supplier is listed for this generic product. Additional details are available on the golodirsen profile page.

When can SIGNIFOR (pasireotide diaspartate) generic drug versions launch?

Generic name: pasireotide diaspartate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 14, 2026
Generic Entry Controlled by: United States Patent Patent 7,473,761

SIGNIFOR is a drug marketed by Recordati Rare. There are four patents protecting this drug.

This drug has eighty-seven patent family members in thirty-nine countries.

See drug price trends for SIGNIFOR.

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

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

Generic name: tafamidis meglumine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 19, 2026
Generic Entry Controlled by: United States Patent Patent 7,214,695

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 EPANOVA (omega-3-carboxylic acids) generic drug versions launch?

Generic name: omega-3-carboxylic acids
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: United States Patent Patent 7,960,370

EPANOVA is a drug marketed by Astrazeneca. There are seven patents protecting this drug.

This drug has eighty-five patent family members in forty-one countries.

The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this API. Additional details are available on the omega-3-carboxylic acids profile page.

When can TISSUEBLUE (brilliant blue g) generic drug versions launch?

Generic name: brilliant blue g
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

TISSUEBLUE is a drug marketed by Dutch Ophthalmic.

This drug has eighty-five patent family members in forty-one countries.

The generic ingredient in TISSUEBLUE is brilliant blue g. One supplier is listed for this generic product. Additional details are available on the brilliant blue g profile page.

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

Last updated: December 24, 2025

Executive Summary

The U.S. pharmaceutical landscape encompasses a dynamic interplay between branded and generic drug markets, driven by innovation, patent protections, and regulatory policies. As of 2023, the U.S. is the world’s largest pharmaceutical market, valued at approximately $560 billion, with branded drugs accounting for about 65% of sales and generics constituting roughly 35%. While innovation continues to propel high-margin branded products, the growth of generics contributes significantly to overall healthcare affordability and cost containment.

This analysis examines market trends, regulatory frameworks, opportunities, and challenges facing both segments. It emphasizes the evolving landscape shaped by patent litigations, biosimilar development, Congress-led policy reforms, and the strategic responses of pharmaceutical stakeholders. Critical insights include the increasing importance of biosimilars, digital health integrations, and patent challenges in fostering competition.


Market Overview: Branded vs. Generic Drugs in the U.S.

Segment Share of Market (2023) Estimated Revenue Growth Rate (CAGR 2021–2026) Key Players Market Drivers
Branded Drugs 65% ~$364 billion 3% Pfizer, Johnson & Johnson, Merck, Novartis Innovation, patent life
Generic Drugs 35% ~$196 billion 8% Teva, Sandoz, Mylan, generic manufacturers Patent expiries, cost sensitivity

Sources: [1], [2], [3].

Key Trends

  • Bureau of Labor Statistics reports patent cliff effects with around 150 drug patents expiring annually.
  • The rise of biosimilars (biologic generics) is disrupting traditional market boundaries, expected to reach $20 billion by 2027.
  • Margins in the generic segment are slimmer, intensifying price competition.
  • Biotech innovation and personalized medicine increase branded drug complexity and exclusivity.

Regulatory Frameworks Governing the U.S. Market

FDA Oversight and Approval Pathways

The U.S. Food and Drug Administration (FDA) supervises drug approvals, safety, and efficacy. The key pathways include:

  • New Drug Application (NDA): For innovative, branded drugs.
  • Abbreviated New Drug Application (ANDA): For generics, emphasizing reference branding.
  • Biologic License Application (BLA): For biologics; biosimilar pathway introduced via the Biologics Price Competition and Innovation Act (2010).
  • Biosimilars Approval: 10 approved biosimilars as of 2022, expanding access to costly biologics.

Patent and Exclusivity Laws

  • Orange Book Listings: Patents listed, with prevailing patent life typically 20 years.
  • Patent Challenges: Hatch-Waxman amendments facilitate generic challenges via paragraph IV certifications.
  • Market Exclusivity: Data exclusivity—typically 5 years for new chemical entities—delays generic entry.

Pricing and Reimbursement Policies

  • Medicare and Medicaid influence drug pricing and reimbursement.
  • The 2020 elimination of rebates in Medicare Part D aimed to foster transparency but faced political resistance.

Opportunities in the U.S. Drug Markets

Opportunity Description Impact Example Initiatives
Biosimilar Development Growing biologics market, fostering biosimilar competition Cost reduction, increased access Amgen's biosimilars for Rituximab and Herceptin
Digital Health Integration Combining pharmaceuticals with digital monitoring Patient adherence, data collection Digital pills, remote monitoring devices
Patent Challenges & Litigation Leveraging ANDA and BPCIA pathways Market share gains, revenue from generics Mylan’s success post patent expiry
Policy Reforms Legislative efforts like the Inflation Reduction Act (2022) Price negotiations, sustainability Medicaid drug price negotiations
International Market Expansion Exporting U.S.-developed drugs Revenue diversification Partnerships in emerging markets

Biosimilars: A Major Growth Driver

The biosimilar segment's expected CAGR (>15%) offers substantial opportunities beyond traditional generics:

  • Lower development costs than novel biologics.
  • Reduced approval times (approx. 10-12 months under biosimilar pathway).
  • Payer incentives favoring biosimilar adoption.

Digital and Personalized Medicine

Emerging digital health solutions can enhance drug efficacy and adherence, leading to novel market entries:

  • Mobile health apps integrated with drug regimens.
  • AI-driven personalized therapy options supported by FDA's Adaptive Pathways.

Challenges Facing Market Participants

Challenge Description Implication Notable Examples
Intellectual Property Litigation Patent trolls, patent expiry challenges Delays, legal costs AbbVie vs. biosimilar entrants
Price Regulation & Policy Uncertainty Legislative caps, price negotiations Profit margin pressure Biden’s drug pricing push efforts
Complex Biologics and Biosimilars Manufacturing complexity, interchangeability Higher R&D costs, regulatory hurdles Lack of interchangeability designations
Market Entry Barriers for Biosimilars Prescriber resistance, patent thickets Reduced biosimilar uptake Slow adoption rates despite approvals
Supply Chain Disruptions Pandemic-related manufacturing issues Drug shortages, increased costs COVID-19 impact on API supply

Patent and Litigation Obstacles

  • Frequent patent litigations cause market delays.
  • "Patent thickets" hinder biosimilar entry.
  • Example: Amgen's litigation strategies delaying Novartis's biosimilar.

Pricing and Reimbursement Pressures

  • Congressional and state-level initiatives aim to lower drug prices.
  • PBMs negotiating rebates impact net revenue.

Manufacturing and Supply Chain Complexity

  • Particularly relevant to biologics and biosimilars.
  • FDA's inspection and manufacturing standards (cGMP) pose high entry barriers.

Comparison between Branded and Generic Markets: Strategic Insights

Aspect Branded Drugs Generic Drugs Biosimilars
Innovation Heavy investment Limited Growing biologic development
Patent Life Up to 20 years Not applicable Approx. 12 years exclusivity
R&D Cost $1-$2 billion Minimal $100-$400 million
Market Entry Long approval times Fast, after patent expiry Moderate, complex biologics
Pricing Power High margins Price competition Moderate, biosimilar discounts

Regulatory Opportunities and Challenges

Opportunities

  • Streamlining Biosimilar Approvals: FDA’s recent initiatives aim for faster pathways, expanding biosimilar market access.
  • Enhanced Patent Protections: Continued refinement of patent laws to balance innovation incentives with market competition.
  • Digital Innovation: Policy support for integrating digital health data into regulatory review processes.

Challenges

  • Patent Litigation Complexity: Legal disputes hinder timely market entry.
  • Interchangeability Designation: Rigorous data requirements delay biosimilar substitution.
  • Pricing Regulations: Political and legislative hurdles limit commercial flexibility.

Future Outlook: 2023–2030

Forecast Details Timeline Risks
Biosimilar Market Exceed $20 billion & account for ~25% of biologics 2027 Market resistance, regulatory delays
Digital Health & Pharma Integration of AI, wearables 2025–2030 Data privacy, FDA regulation adaptation
Policy Reforms Focus on transparency, affordability Ongoing Political opposition, legal challenges

Key Takeaways

  • The U.S. pharmaceutical market remains bifurcated, with innovation-driven branded drugs maintaining high margins and generics driving cost containment.
  • Regulatory policies, including patent law and approval pathways, are pivotal in shaping market dynamics.
  • Biosimilars present significant growth opportunities, yet face unique regulatory and market hurdles.
  • Price regulation initiatives could influence profit margins, motivating strategic adaptation.
  • Digital health integration and personalized medicine are emerging frontiers with regulatory and commercial implications.
  • Market entrants must navigate patent litigations, complex approval processes, and evolving policy landscapes to succeed.

FAQs

1. How do patent expirations impact the U.S. generic drug market?

Patent expirations create opportunities for generic manufacturers to enter the market, often leading to substantial price reductions and increased access. The Hatch-Waxman Act facilitates generic entry through legal pathways like paragraph IV challenges, but patent litigations can cause delays averaging 2–4 years.

2. What are the main regulatory hurdles facing biosimilar approval?

Biosimilars face rigorous FDA requirements, including demonstrating interchangeability and comparable safety and efficacy. Achieving the interchangeability designation—which allows pharmacy-level substitution—requires additional data and delays approval.

3. How are policy initiatives affecting drug prices in the U.S.?

Legislative efforts aim to lower retail drug prices through negotiations (e.g., Medicare price negotiations), transparency mandates, and restrictions on rebates. These policies create financial pressure on branded manufacturers but open opportunities for generics and biosimilars.

4. What role does biosimilar development play in the future pharmaceutical market?

Biosimilars are poised to reduce biological therapy costs, expand patient access, and intensify competition. Their growth hinges on regulatory clarity, prescriber acceptance, and patent strategies.

5. How is digital health influencing pharmaceutical innovation in the U.S.?

Digital health enables personalized medicine, improves adherence, and offers new data-driven pathways for regulatory approval and post-market surveillance, fostering innovation and market differentiation.


References

  1. IQVIA Institute for Human Data Science, 2023. The United States Pharmaceutical Market Report.
  2. FDA, 2022. Biosimilar Development and Approval Process.
  3. U.S. Census Bureau, 2022. Pharmaceutical Sales Data.
  4. Biotech Innovation Organization, 2022. Biosimilars Market Outlook.
  5. Congressional Budget Office, 2022. Legislative Impact on Drug Pricing.

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