26 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, "26 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.
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 are two patents 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 eleven patents protecting this drug.
This drug has one hundred and sixty-eight 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 forty-one patent family members in twenty-five 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 thirty-two 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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and fifty-nine patent family members in forty-five 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-one 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.
APTIVUS
Generic name: tipranavir
Patent Expiration / Generic Entry Opportunity April 29, 2020
Generic Entry Controlled by: Patent 5,852,195
This drug has one hundred and fifty-six patent family members in thirty-one countries.
See drug price trends for APTIVUS.
The generic ingredient in APTIVUS is tipranavir. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the tipranavir profile page.
ABLAVAR
Generic name: gadofosveset trisodium
Patent Expiration / Generic Entry Opportunity May 04, 2020
Generic Entry Controlled by: Patent 6,676,929
ABLAVAR is a drug marketed by Lantheus Medcl. There is one patent protecting this drug.
This drug has forty-three patent family members in twenty-six countries.
The generic ingredient in ABLAVAR is gadofosveset trisodium. Additional details are available on the gadofosveset trisodium profile page.
FORTOVASE
Generic name: saquinavir
Patent Expiration / Generic Entry Opportunity May 16, 2020
Generic Entry Controlled by: Patent 6,352,717
FORTOVASE is a drug marketed by Hoffmann La Roche. There is one patent protecting this drug.
This drug has forty patent family members in thirty-four countries.
The generic ingredient in FORTOVASE is saquinavir. There is one drug master file entry for this API. Additional details are available on the saquinavir profile page.
VIVITROL
Generic name: naltrexone
Patent Expiration / Generic Entry Opportunity May 19, 2020
Generic Entry Controlled by: Patent 6,379,704
This drug has one hundred and thirteen patent family members in twenty-eight countries. There has been litigation on patents covering VIVITROL
See drug price trends for VIVITROL.
The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the naltrexone profile page.
EGRIFTA
Generic name: tesamorelin acetate
Patent Expiration / Generic Entry Opportunity May 26, 2020
Generic Entry Controlled by: Patent 5,861,379
EGRIFTA is a drug marketed by Theratechnologies. There are five patents protecting this drug.
This drug has forty-four patent family members in sixteen countries.
See drug price trends for EGRIFTA.
The generic ingredient in EGRIFTA is tesamorelin acetate. One supplier is listed for this generic product. Additional details are available on the tesamorelin acetate profile page.
QSYMIA
Generic name: phentermine hydrochloride; topiramate
Patent Expiration / Generic Entry Opportunity June 14, 2020
Generic Entry Controlled by: Patent 7,674,776
This drug has sixty-four patent family members in nineteen countries. There has been litigation on patents covering QSYMIA
See drug price trends for QSYMIA.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the phentermine hydrochloride; topiramate profile page.
DENAVIR
Generic name: penciclovir
Patent Expiration / Generic Entry Opportunity June 17, 2020
Generic Entry Controlled by: Patent 5,075,445
This drug has one hundred and five patent family members in thirty-four countries. There has been litigation on patents covering DENAVIR
See drug price trends for DENAVIR.
The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the penciclovir profile page.
XTORO
Generic name: finafloxacin
Patent Expiration / Generic Entry Opportunity June 17, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
XTORO is a drug marketed by Merlion Pharms Gmbh. There are three patents protecting this drug.
This drug has thirty-eight patent family members in eighteen countries.
The generic ingredient in XTORO is finafloxacin. Additional details are available on the finafloxacin profile page.
VIMOVO
Generic name: esomeprazole magnesium; naproxen
Patent Expiration / Generic Entry Opportunity July 06, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
VIMOVO is a drug marketed by Horizon. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has fifty patent family members in twenty-three countries. There has been litigation on patents covering VIMOVO
See drug price trends for VIMOVO.
The generic ingredient in VIMOVO is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the esomeprazole magnesium; naproxen profile page.
VYXEOS
Generic name: cytarabine; daunorubicin
Patent Expiration / Generic Entry Opportunity August 03, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
VYXEOS is a drug marketed by Celator Pharms. There are eight patents protecting this drug.
This drug has one hundred and nine patent family members in twenty-one countries.
See drug price trends for VYXEOS.
The generic ingredient in VYXEOS is cytarabine; daunorubicin . There are fifteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the cytarabine; daunorubicin profile page.
CIPRODEX
Generic name: ciprofloxacin; dexamethasone
Patent Expiration / Generic Entry Opportunity August 10, 2020
Generic Entry Controlled by: Patent 6,359,016
CIPRODEX is a drug marketed by Novartis Pharms Corp. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has forty-three patent family members in twenty-two countries. There has been litigation on patents covering CIPRODEX
See drug price trends for CIPRODEX.
The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the ciprofloxacin; dexamethasone profile page.
SOLAGE
Generic name: mequinol; tretinoin
Patent Expiration / Generic Entry Opportunity August 24, 2020
Generic Entry Controlled by: Patent 5,194,247
SOLAGE is a drug marketed by Almirall. There is one patent protecting this drug.
This drug has thirteen patent family members in twelve countries.
The generic ingredient in SOLAGE is mequinol; tretinoin. Additional details are available on the mequinol; tretinoin profile page.
DOTAREM
Generic name: gadoterate meglumine
Patent Expiration / Generic Entry Opportunity August 25, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
DOTAREM is a drug marketed by Guerbet.
This drug has thirteen patent family members in twelve countries.
See drug price trends for DOTAREM.
The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this generic product. Additional details are available on the gadoterate meglumine profile page.
BIDIL
Generic name: hydralazine hydrochloride; isosorbide dinitrate
Patent Expiration / Generic Entry Opportunity September 08, 2020
Generic Entry Controlled by: Patent 6,465,463
BIDIL is a drug marketed by Arbor Pharms Llc. There are two patents protecting this drug.
This drug has four patent family members in four countries.
See drug price trends for BIDIL.
The generic ingredient in BIDIL is hydralazine hydrochloride; isosorbide dinitrate. 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 hydralazine hydrochloride; isosorbide dinitrate profile page.
RAPIVAB
Generic name: peramivir
Patent Expiration / Generic Entry Opportunity September 20, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
RAPIVAB is a drug marketed by Biocryst. There are three patents protecting this drug.
This drug has sixty-one patent family members in twenty-eight countries.
See drug price trends for RAPIVAB.
The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.
CORLANOR
Generic name: ivabradine hydrochloride
Patent Expiration / Generic Entry Opportunity October 15, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity
This drug has ninety-seven patent family members in forty-two countries.
See drug price trends for CORLANOR.
The generic ingredient in CORLANOR is ivabradine hydrochloride. 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 hydrochloride profile page.
THALOMID
Generic name: thalidomide
Patent Expiration / Generic Entry Opportunity October 23, 2020
Generic Entry Controlled by: Patent 6,315,720
THALOMID is a drug marketed by Celgene. There are nine patents protecting this drug and three Paragraph IV challenges.
This drug has forty-seven patent family members in nineteen countries. There has been litigation on patents covering THALOMID
See drug price trends for THALOMID.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the thalidomide profile page.
