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Last Updated: October 5, 2024

United States: These 35 Drugs Face Patent Expirations and Generic Entry From 2024 - 2025

DrugPatentWatch® Estimated Loss of Exclusivity Dates in the United States

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Preferred citation:
Friedman, Yali, "United States: These 35 Drugs Face Patent Expirations and Generic Entry From 2024 - 2025" DrugPatentWatch.com thinkBiotech, 2024 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 XOPENEX HFA (levalbuterol tartrate) generic drug versions launch?

Generic name: levalbuterol tartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 08, 2024
Generic Entry Controlled by: United States Patent Patent 7,256,310

Drug Price Trends for XOPENEX HFA
XOPENEX HFA is a drug marketed by Lupin. There is one patent protecting this drug.

This drug has thirty-six patent family members in eighteen countries. There has been litigation on patents covering XOPENEX HFA

See drug price trends for XOPENEX HFA.

The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the levalbuterol tartrate profile page.

When can FLUORODOPA F18 (fluorodopa f-18) generic drug versions launch?

Generic name: fluorodopa f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 10, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

FLUORODOPA F18 is a drug marketed by Feinstein.

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

The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this generic product. Additional details are available on the fluorodopa f-18 profile page.

When can BYETTA (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 04, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

Drug Price Trends for BYETTA
BYETTA is a drug marketed by Astrazeneca Ab.

This drug has thirty-six patent family members in eighteen countries. There has been litigation on patents covering BYETTA

See drug price trends for BYETTA.

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

When can EXEM FOAM KIT (air polymer-type a) generic drug versions launch?

Generic name: air polymer-type a
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity

EXEM FOAM KIT is a drug marketed by Giskit. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the air polymer-type a profile page.

When can NOURIANZ (istradefylline) generic drug versions launch?

Generic name: istradefylline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2024
Generic Entry Controlled by: United States Patent Patent 7,541,363

NOURIANZ is a drug marketed by Kyowa Kirin. There are three patents protecting this drug.

This drug has sixty-three patent family members in eighteen countries.

See drug price trends for NOURIANZ.

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

When can MACRILEN (macimorelin acetate) generic drug versions launch?

Generic name: macimorelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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.

When can RYALTRIS (mometasone furoate; olopatadine hydrochloride) generic drug versions launch?

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

Drug Price Trends for RYALTRIS
RYALTRIS is a drug marketed by Glenmark Speclt. There are fourteen patents protecting this drug.

This drug has eighty-eight patent family members in thirty-two 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.

When can SANCUSO (granisetron) generic drug versions launch?

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

Drug Price Trends for SANCUSO
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. One supplier is listed for this generic product. Additional details are available on the granisetron profile page.

When can DUAKLIR PRESSAIR (aclidinium bromide; formoterol fumarate) generic drug versions launch?

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

When can TUDORZA PRESSAIR (aclidinium bromide) generic drug versions launch?

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

When can PIZENSY (lactitol) generic drug versions launch?

Generic name: lactitol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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.

When can IZERVAY (avacincaptad pegol sodium) generic drug versions launch?

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

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

This drug has one hundred 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.

When can IXEMPRA KIT (ixabepilone) generic drug versions launch?

Generic name: ixabepilone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 21, 2025
Generic Entry Controlled by: United States Patent 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.

When can BARHEMSYS (amisulpride) generic drug versions launch?

Generic name: amisulpride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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.

When can XARELTO (rivaroxaban) generic drug versions launch?

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

Drug Price Trends for XARELTO
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.

When can JUXTAPID (lomitapide mesylate) generic drug versions launch?

Generic name: lomitapide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 07, 2025
Generic Entry Controlled by: United States Patent 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.

When can SMOFLIPID 20% (fish oil; medium chain triglycerides; olive oil; soybean oil) generic drug versions launch?

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

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

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

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.

When can XELSTRYM (dextroamphetamine) generic drug versions launch?

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

Drug Price Trends for XELSTRYM
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.

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

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

Drug Price Trends for TLANDO
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.

When can TARGINIQ (naloxone hydrochloride; oxycodone hydrochloride) generic drug versions launch?

Generic name: naloxone hydrochloride; oxycodone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2025
Generic Entry Controlled by: United States Patent 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.

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

Generic name: rilpivirine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2025
Generic Entry Controlled by: United States Patent 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.

When can XARELTO (rivaroxaban) generic drug versions launch?

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

Drug Price Trends for XARELTO
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.

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.

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

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 FOLOTYN (pralatrexate) generic drug versions launch?

Generic name: pralatrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2025
Generic Entry Controlled by: United States Patent 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.

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.

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

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 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 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.

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-one patents protecting this drug.

This drug has two hundred and thirty-five 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. Two suppliers are listed for this generic product. Additional details are available on the nepafenac profile page.

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