Drug Patent Expirations and Generic Entry Opportunities
2018 - 2019

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Preferred citation:
Friedman, Yali, "Drug Patent Expirations and Generic Entry Opportunities 2018 - 2019" DrugPatentWatch.com thinkBiotech, 2018 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 employed here is described in this blog post.

ONFI

Generic name: clobazam
Patent Expiration / Generic Entry Opportunity October 21, 2018
Generic Entry Controlled by: FDA Regulatory Exclusivity

ONFI is a drug marketed by Lundbeck Pharms Llc.

See drug price trends for ONFI.

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

FORTEO

Generic name: teriparatide recombinant human
Patent Expiration / Generic Entry Opportunity December 08, 2018
Generic Entry Controlled by: Patent 6,770,623

FORTEO is a drug marketed by Lilly. There are seven patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering FORTEO

See drug price trends for FORTEO.

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

ACTONEL WITH CALCIUM (COPACKAGED)

Generic name: calcium carbonate; risedronate sodium
Patent Expiration / Generic Entry Opportunity December 10, 2018
Generic Entry Controlled by: Patent 6,165,513

ACTONEL WITH CALCIUM (COPACKAGED) is a drug marketed by Warner Chilcott. There are five patents protecting this drug. There has been litigation on patents covering ACTONEL WITH CALCIUM (COPACKAGED)

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) is calcium carbonate; risedronate sodium. There are two hundred and seventy-eight drug master file entries for this API. Additional details are available on the calcium carbonate; risedronate sodium profile page.

MOZOBIL

Generic name: plerixafor
Patent Expiration / Generic Entry Opportunity December 10, 2018
Generic Entry Controlled by: Patent RE42152

MOZOBIL is a drug marketed by Genzyme. There are three patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering MOZOBIL

See drug price trends for MOZOBIL.

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

PYLERA

Generic name: bismuth subcitrate potassium; metronidazole; tetracycline
Patent Expiration / Generic Entry Opportunity December 14, 2018
Generic Entry Controlled by: Patent 6,350,468

PYLERA is a drug marketed by Allergan Sales Llc. There is one patent protecting this drug and one Paragraph IV challenge.

See drug price trends for PYLERA.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline profile page.

BASAGLAR

Generic name: insulin glargine
Patent Expiration / Generic Entry Opportunity December 16, 2018
Generic Entry Controlled by: FDA Regulatory Exclusivity

BASAGLAR is a drug marketed by Eli Lilly And Co.

See drug price trends for BASAGLAR.

The generic ingredient in BASAGLAR is insulin glargine. There are forty drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the insulin glargine profile page.

ELIDEL

Generic name: pimecrolimus
Patent Expiration / Generic Entry Opportunity December 26, 2018
Generic Entry Controlled by: Patent 6,423,722

ELIDEL is a drug marketed by Valeant Bermuda. There is one patent protecting this drug. There has been litigation on patents covering ELIDEL

See drug price trends for ELIDEL.

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

FOSAMAX PLUS D

Generic name: alendronate sodium; cholecalciferol
Patent Expiration / Generic Entry Opportunity January 17, 2019
Generic Entry Controlled by: Patent 5,994,329

FOSAMAX PLUS D is a drug marketed by Merck. There is one patent protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering FOSAMAX PLUS D

See drug price trends for FOSAMAX PLUS D.

The generic ingredient in FOSAMAX PLUS D is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the alendronate sodium; cholecalciferol profile page.

SYMLIN

Generic name: pramlintide acetate
Patent Expiration / Generic Entry Opportunity March 16, 2019
Generic Entry Controlled by: Patent 5,686,411

SYMLIN is a drug marketed by Astrazeneca Ab. There is one patent protecting this drug.

See drug price trends for SYMLIN.

The generic ingredient in SYMLIN is pramlintide acetate. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pramlintide acetate profile page.

TECFIDERA

Generic name: dimethyl fumarate
Patent Expiration / Generic Entry Opportunity April 01, 2019
Generic Entry Controlled by: Patent 6,509,376

TECFIDERA is a drug marketed by Biogen Idec Inc. There are seven patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering TECFIDERA

See drug price trends for TECFIDERA.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dimethyl fumarate profile page.

FLECTOR

Generic name: diclofenac epolamine
Patent Expiration / Generic Entry Opportunity April 13, 2019
Generic Entry Controlled by: Patent 5,607,690

FLECTOR is a drug marketed by Inst Biochem. There is one patent protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering FLECTOR

See drug price trends for FLECTOR.

The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this API. Ten suppliers are listed for this generic product. Additional details are available on the diclofenac epolamine profile page.

CETROTIDE

Generic name: cetrorelix
Patent Expiration / Generic Entry Opportunity April 23, 2019
Generic Entry Controlled by: Patent 5,198,533

CETROTIDE is a drug marketed by Emd Serono Inc. There is one patent protecting this drug.

See drug price trends for CETROTIDE.

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

OMTRYG

Generic name: omega-3-acid ethyl esters type a
Patent Expiration / Generic Entry Opportunity April 23, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

OMTRYG is a drug marketed by Osmotica.

The generic ingredient in OMTRYG is omega-3-acid ethyl esters type a. There are thirteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the omega-3-acid ethyl esters type a profile page.

BEVESPI AEROSPHERE

Generic name: formoterol fumarate; glycopyrrolate
Patent Expiration / Generic Entry Opportunity April 25, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

BEVESPI AEROSPHERE is a drug marketed by Astrazeneca Pharms. There are six patents protecting this drug.

See drug price trends for BEVESPI AEROSPHERE.

The generic ingredient in BEVESPI AEROSPHERE is formoterol fumarate; glycopyrrolate. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the formoterol fumarate; glycopyrrolate profile page.

OTOVEL

Generic name: ciprofloxacin hydrochloride; fluocinolone acetonide
Patent Expiration / Generic Entry Opportunity April 29, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

OTOVEL is a drug marketed by Laboratorios Salvat. There is one patent protecting this drug.

See drug price trends for OTOVEL.

The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.

BYVALSON

Generic name: nebivolol hydrochloride; valsartan
Patent Expiration / Generic Entry Opportunity June 03, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

BYVALSON is a drug marketed by Allergan Sales Llc. There are two patents protecting this drug and one Paragraph IV challenge.

See drug price trends for BYVALSON.

The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the nebivolol hydrochloride; valsartan profile page.

RESCRIPTOR

Generic name: delavirdine mesylate
Patent Expiration / Generic Entry Opportunity June 07, 2019
Generic Entry Controlled by: Patent 6,177,101

RESCRIPTOR is a drug marketed by Viiv Hlthcare. There is one patent protecting this drug.

See drug price trends for RESCRIPTOR.

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

NATROBA

Generic name: spinosad
Patent Expiration / Generic Entry Opportunity June 22, 2019
Generic Entry Controlled by: Patent 6,342,482

NATROBA is a drug marketed by Parapro Llc. There are three patents protecting this drug.

See drug price trends for NATROBA.

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

KOVANAZE

Generic name: oxymetazoline hydrochloride; tetracaine hydrochloride
Patent Expiration / Generic Entry Opportunity June 29, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

KOVANAZE is a drug marketed by St Renatus. There are three patents protecting this drug.

The generic ingredient in KOVANAZE is oxymetazoline hydrochloride; tetracaine hydrochloride. There are three drug master file entries for this API. Additional details are available on the oxymetazoline hydrochloride; tetracaine hydrochloride profile page.

FIRAZYR

Generic name: icatibant acetate
Patent Expiration / Generic Entry Opportunity July 15, 2019
Generic Entry Controlled by: Patent 5,648,333

FIRAZYR is a drug marketed by Shire Orphan Therap. There is one patent protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering FIRAZYR

See drug price trends for FIRAZYR.

The generic ingredient in FIRAZYR is icatibant acetate. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the icatibant acetate profile page.

NOXAFIL

Generic name: posaconazole
Patent Expiration / Generic Entry Opportunity July 19, 2019
Generic Entry Controlled by: Patent 5,661,151

NOXAFIL is a drug marketed by Merck Sharp Dohme and ScheringThere are eight patents protecting this drug and three Paragraph IV challenges. There has been litigation on patents covering NOXAFIL

See drug price trends for NOXAFIL.

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

CARDIOTEC

Generic name: technetium tc-99m teboroxime kit
Patent Expiration / Generic Entry Opportunity July 28, 2019
Generic Entry Controlled by: Patent 6,056,941

CARDIOTEC is a drug marketed by Bracco. There is one patent protecting this drug.

The generic ingredient in CARDIOTEC is technetium tc-99m teboroxime kit. There are four drug master file entries for this API. Additional details are available on the technetium tc-99m teboroxime kit profile page.

TROXYCA ER

Generic name: naltrexone hydrochloride; oxycodone hydrochloride
Patent Expiration / Generic Entry Opportunity August 19, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

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

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.

YOSPRALA

Generic name: aspirin; omeprazole
Patent Expiration / Generic Entry Opportunity September 14, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

YOSPRALA is a drug marketed by Genus Lifesciences. There are five patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering YOSPRALA

See drug price trends for YOSPRALA.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the aspirin; omeprazole profile page.

CYSTARAN

Generic name: cysteamine hydrochloride
Patent Expiration / Generic Entry Opportunity October 02, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

CYSTARAN is a drug marketed by Leadiant Biosci Inc.

See drug price trends for CYSTARAN.

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

LUMASON

Generic name: sulfur hexafluoride lipid-type a microspheres
Patent Expiration / Generic Entry Opportunity October 10, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

LUMASON is a drug marketed by Bracco. There is one patent protecting this drug.

See drug price trends for LUMASON.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

SYNRIBO

Generic name: omacetaxine mepesuccinate
Patent Expiration / Generic Entry Opportunity October 26, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

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

See drug price trends for SYNRIBO.

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

IONSYS

Generic name: fentanyl hydrochloride
Patent Expiration / Generic Entry Opportunity November 02, 2019
Generic Entry Controlled by: Patent 6,181,963

IONSYS is a drug marketed by The Medicines Co. There are twelve patents protecting this drug.

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

SIMBRINZA

Generic name: brimonidine tartrate; brinzolamide
Patent Expiration / Generic Entry Opportunity December 07, 2019
Generic Entry Controlled by: Patent 6,316,441

SIMBRINZA is a drug marketed by Novartis Pharms Corp. There are three patents protecting this drug.

See drug price trends for SIMBRINZA.

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

DUREZOL

Generic name: difluprednate
Patent Expiration / Generic Entry Opportunity December 13, 2019
Generic Entry Controlled by: FDA Regulatory Exclusivity

DUREZOL is a drug marketed by Novartis Pharms Corp. There is one patent protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering DUREZOL

See drug price trends for DUREZOL.

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