27 Drugs Facing Patent Expirations and Generic Entry in 2019 - 2020
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "27 Drugs Facing Patent Expirations and Generic Entry in 2019 - 2020" DrugPatentWatch.com thinkBiotech, 2019 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.
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.
This drug has thirty-two patent family members in sixteen countries.
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.
This drug has sixty-nine patent family members in thirty-three countries. 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
This drug has ten patent family members in nine countries. 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. Nine 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.
This drug has twenty-eight patent family members in twenty-two countries.
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.
This drug has twenty-eight patent family members in twenty-two countries.
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.
This drug has one hundred and ten patent family members in twenty-seven countries.
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
This drug has sixteen patent family members in thirteen countries.
See drug price trends for OTOVEL.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four 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
This drug has thirty-seven patent family members in fifteen countries.
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.
This drug has twenty-five patent family members in twenty countries.
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
This drug has forty-eight patent family members in thirty countries.
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.
This drug has twenty-three patent family members in thirteen countries.
The generic ingredient in KOVANAZE is oxymetazoline hydrochloride; tetracaine hydrochloride. There are three drug master file entries for this API. One supplier is listed for this generic product. 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.
This drug has one hundred and fourteen patent family members in thirty-three countries. There has been litigation on patents covering FIRAZYR
See drug price trends for FIRAZYR.
The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen 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
This drug has one hundred and thirty-eight patent family members in thirty-four countries. There has been litigation on patents covering NOXAFIL
See drug price trends for NOXAFIL.
The generic ingredient in NOXAFIL is posaconazole. 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 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.
This drug has ten patent family members in seven countries.
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.
This drug has ten patent family members in six 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.
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.
This drug has forty-five patent family members in twenty-three countries. 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.
This drug has forty-five patent family members in twenty-three countries.
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.
This drug has one hundred and forty-one patent family members in twenty-eight countries.
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. Two suppliers are 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.
This drug has forty-nine patent family members in nineteen 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. 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.
This drug has one hundred and seventy-five patent family members in thirty-three countries.
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
This drug has thirty-nine patent family members in twenty-four countries.
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
This drug has six patent family members in five countries. 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.
VASCEPA
Generic name: icosapent ethyl
Patent Expiration / Generic Entry Opportunity January 27, 2020
Generic Entry Controlled by: Patent 8,188,146
This drug has one hundred and sixty-one patent family members in forty-one countries. There has been litigation on patents covering VASCEPA
See drug price trends for VASCEPA.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the icosapent ethyl profile page.
POMALYST
Generic name: pomalidomide
Patent Expiration / Generic Entry Opportunity February 08, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
POMALYST is a drug marketed by Celgene. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and forty patent family members in forty-three countries. There has been litigation on patents covering POMALYST
See drug price trends for POMALYST.
The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pomalidomide profile page.
JUXTAPID
Generic name: lomitapide mesylate
Patent Expiration / Generic Entry Opportunity February 21, 2020
Generic Entry Controlled by: Patent 5,712,279
JUXTAPID is a drug marketed by Aegerion. There are nine patents protecting this drug.
This drug has ninety-two patent family members in thirty-seven 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. One supplier is listed for this generic product. Additional details are available on the lomitapide mesylate profile page.
QBREXZA
Generic name: glycopyrronium tosylate
Patent Expiration / Generic Entry Opportunity April 10, 2020
Generic Entry Controlled by: Patent 6,433,003
This drug has twenty-two patent family members in twelve countries.
See drug price trends for QBREXZA.
The generic ingredient in QBREXZA is glycopyrronium tosylate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the glycopyrronium tosylate profile page.
GATTEX KIT
Generic name: teduglutide recombinant
Patent Expiration / Generic Entry Opportunity April 14, 2020
Generic Entry Controlled by: Patent 5,789,379
GATTEX KIT is a drug marketed by Nps Pharms Inc. There are twenty-one patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-two patent family members in eighteen 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. One supplier is listed for this generic product. Additional details are available on the teduglutide recombinant profile page.