Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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Atazanavir sulfate; cobicistat - Generic Drug Details

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What are the generic drug sources for atazanavir sulfate; cobicistat and what is the scope of freedom to operate?

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.

Atazanavir sulfate; cobicistat has three hundred and thirteen patent family members in fifty-two countries.

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

Summary for atazanavir sulfate; cobicistat
Recent Litigation for atazanavir sulfate; cobicistat

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bristol-Myers Squibb Company v. Apotex Inc.2017-10-24
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc.2017-02-22
Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc.2016-03-25

See all atazanavir sulfate; cobicistat litigation

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE; COBICISTAT
Tradename Dosage Ingredient NDA Submissiondate
EVOTAZ TABLET;ORAL atazanavir sulfate; cobicistat 206353 2017-09-13

US Patents and Regulatory Information for atazanavir sulfate; cobicistat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for atazanavir sulfate; cobicistat

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015   Start Trial   Start Trial
Bristol-myers Squibb EVOTAZ atazanavir sulfate; cobicistat TABLET;ORAL 206353-001 Jan 29, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for atazanavir sulfate; cobicistat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 122016000103 Germany   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487163 60/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2049506 262 5024-2015 Slovakia   Start Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZA-; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487162 93352 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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