United States: These 32 Drugs Face Patent Expirations and Generic Entry in 2024 - 2025

Generic name: naltrexone hydrochloride; oxycodone hydrochloride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: July 03, 2025
Generic Entry Controlled by: United States 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.

Generic name: migalastat hydrochloride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity 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-one patents protecting this drug.

This drug has two hundred and thirty-nine 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.

Generic name: lomitapide mesylate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 07, 2025
Generic Entry Controlled by: United States Patent 8,618,135

JUXTAPID is a drug marketed by Chiesi. There are eight patents protecting this drug.

This drug has twenty-seven patent family members in eighteen countries. There has been litigation on patents covering JUXTAPID

See drug price trends for JUXTAPID.

The generic ingredient in JUXTAPID is lomitapide mesylate. There are two drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the lomitapide mesylate profile page.

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

OMEGAVEN is a drug marketed by Fresenius Kabi Usa. There are three 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.

Generic name: fish oil; medium chain triglycerides; olive oil; soybean oil
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 22, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

SMOFLIPID 20% is a drug marketed by Fresenius Kabi Usa.

The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. 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; medium chain triglycerides; olive oil; soybean oil profile page.

Generic name: macimorelin acetate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: December 20, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

MACRILEN is a drug marketed by Novo. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

See drug price trends for MACRILEN.

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

Generic name: lactitol
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 12, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

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

The generic ingredient in PIZENSY is lactitol. There are four drug master file entries for this API. Additional details are available on the lactitol profile page.

Generic name: ixabepilone
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 21, 2025
Generic Entry Controlled by: United States Patent 7,312,237

IXEMPRA KIT is a drug marketed by R-pharm Us Llc. There is one patent protecting this drug and one Paragraph IV challenge.

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

See drug price trends for IXEMPRA KIT.

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

Generic name: aclidinium bromide; formoterol fumarate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 10, 2025
Generic Entry Controlled by: United States Patent RE46417

DUAKLIR PRESSAIR is a drug marketed by Covis. There are four patents protecting this drug.

This drug has one hundred and fifty-six patent family members in forty-six countries.

See drug price trends for DUAKLIR PRESSAIR.

The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. There is one drug master file entry for this API. Two suppliers are listed for this generic product. Additional details are available on the aclidinium bromide; formoterol fumarate profile page.

Generic name: aclidinium bromide
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 10, 2025
Generic Entry Controlled by: United States Patent RE46417

TUDORZA PRESSAIR is a drug marketed by Covis. There are four patents protecting this drug.

This drug has one hundred and fifty-six patent family members in forty-six countries.

See drug price trends for TUDORZA PRESSAIR.

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

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

AZEDRA is a drug marketed by Progenics Pharms Inc.

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.

Generic name: amisulpride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 26, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

BARHEMSYS is a drug marketed by Acacia. There are five patents protecting this drug.

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

See drug price trends for BARHEMSYS.

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

Generic name: fluoroestradiol f-18
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity 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.

Generic name: pralatrexate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: May 31, 2025
Generic Entry Controlled by: United States Patent 8,299,078

FOLOTYN is a drug marketed by Acrotech Biopharma. 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 thirty-one patent family members in twenty-three countries. There has been litigation on patents covering FOLOTYN

See drug price trends for FOLOTYN.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pralatrexate profile page.

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

TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

This drug has fifty-three 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.

Generic name: naloxone hydrochloride; oxycodone hydrochloride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 30, 2025
Generic Entry Controlled by: United States Patent 9,522,919

TARGINIQ is a drug marketed by Purdue Pharma Lp. There are two patents protecting this drug.

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

The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this API. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.

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

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.

Generic name: rivaroxaban
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: May 13, 2025
Generic Entry Controlled by: United States Patent 9,415,053

XARELTO is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for XARELTO.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the rivaroxaban profile page.

Generic name: granisetron
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: January 22, 2025
Generic Entry Controlled by: United States Patent 7,608,282

SANCUSO is a drug marketed by Cumberland. There is one patent protecting this drug and one Paragraph IV challenge.

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

See drug price trends for SANCUSO.

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

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

OTREXUP is a drug marketed by Otter Pharms. There are fourteen patents protecting this drug.

This drug has thirty-seven 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.

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

SOLUPREP is a drug marketed by 3m Health Care.

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.

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

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. Two suppliers are listed for this generic product. Additional details are available on the nepafenac profile page.

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

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

This drug has two hundred and seventy-two patent family members in thirty-one 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.

Generic name: estradiol acetate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: October 02, 2025
Generic Entry Controlled by: United States 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.

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

KRINTAFEL is a drug marketed by Glaxosmithkline.

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.

Generic name: voclosporin
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity 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-three patent family members in thirty-nine countries.

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.

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

GALLIUM GA 68 PSMA-11 is a drug marketed by

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. Additional details are available on the gallium ga-68 psma-11 profile page.

Generic name: alcohol
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity 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.

Generic name: rivaroxaban
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 28, 2025
Generic Entry Controlled by: United States Patent 7,157,456

XARELTO is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for XARELTO.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the rivaroxaban profile page.

Generic name: mometasone furoate; olopatadine hydrochloride
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: January 13, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

RYALTRIS is a drug marketed by Glenmark Speclt. There are fifteen patents protecting this drug.

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

See drug price trends for RYALTRIS.

The generic ingredient in RYALTRIS is mometasone furoate; olopatadine hydrochloride. There are thirty drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the mometasone furoate; olopatadine hydrochloride profile page.

Generic name: testosterone undecanoate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 28, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

TLANDO is a drug marketed by Verity. There are thirteen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-six patent family members in fifteen countries.

See drug price trends for TLANDO.

The generic ingredient in TLANDO 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.

Generic name: dextroamphetamine
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: March 22, 2025
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

XELSTRYM is a drug marketed by Noven Pharms Inc. There are six patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in twelve countries. There has been litigation on patents covering XELSTRYM

See drug price trends for XELSTRYM.

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

Generic name: testosterone undecanoate
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity 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.

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

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.

Generic name: avacincaptad pegol sodium
DrugPatentWatch^® Estimated Patent Expiration / Generic Entry Opportunity Date: February 14, 2025
Generic Entry Controlled by: United States Patent 10,947,544

IZERVAY is a drug marketed by Astellas. There are nine patents protecting this drug.

This drug has one hundred and two patent family members in twenty-seven countries.

See drug price trends for IZERVAY.

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

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

EDURANT PED is a drug marketed by Janssen Prods. There are two patents protecting this drug.

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

The generic ingredient in EDURANT PED 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.