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Atazanavir sulfate; cobicistat - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for atazanavir sulfate; cobicistat?

Atazanavir sulfate; cobicistat is the generic ingredient in one branded drug marketed by Bristol-myers Squibb and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ninety-six patent family members in forty-eight countries.

There are twenty-two drug master file entries for atazanavir sulfate; cobicistat. Two suppliers are listed for this compound.

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYesYes5,849,911*PED► SubscribeY► Subscribe
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYesYes8,148,374► SubscribeYY ► Subscribe
Bristol-myers Squibb
EVOTAZ
atazanavir sulfate; cobicistat
TABLET;ORAL206353-001Jan 29, 2015RXYesYes6,087,383*PED► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: atazanavir sulfate; cobicistat

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,486,942Modulators of pharmacokinetic properties of therapeutics► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
6,110,946 Antivirally active heterocyclic azahexane derivatives► Subscribe
6,166,004 Combinations of HIV protease inhibitors with reverse transcriptase inhibitors► Subscribe
8,383,655Modulators of pharmacokinetic properties of therapeutics► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: atazanavir sulfate; cobicistat

Country Document Number Estimated Expiration
Eurasian Patent Organization201270738► Subscribe
Latvia12522► Subscribe
Denmark2487163► Subscribe
European Patent Office2487163► Subscribe
South Korea101664154► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ATAZANAVIR SULFATE; COBICISTAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0030France► SubscribePRODUCT NAME: ATAZANAVIR ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/03/267/001 DU 20040302; REGISTRATION NO/DATE AT EEC: EU/1/03/237/001 DU 20040302
2016038Lithuania► SubscribePRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0861Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
0860Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
/2015Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
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