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Last Updated: September 19, 2020

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EVOTAZ Drug Profile

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Which patents cover Evotaz, and when can generic versions of Evotaz launch?

Evotaz is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-six patent family members in thirty-nine countries.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

US ANDA Litigation and Generic Entry Outlook for Evotaz

Evotaz was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2032. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for EVOTAZ
Drug Prices for EVOTAZ

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Generic Entry Opportunity Date for EVOTAZ
Generic Entry Date for EVOTAZ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EVOTAZ

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St Stephens Aids TrustPhase 1
Gilead SciencesPhase 3
Bristol-Myers SquibbPhase 1

See all EVOTAZ clinical trials

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

US Patents and Regulatory Information for EVOTAZ

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 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 EVOTAZ

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 EVOTAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 PA2016039 Lithuania   Start Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2049506 300780 Netherlands   Start Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506 PA2015040 Lithuania   Start Trial PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2487162 17C1002 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2487162 1790003-6 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REG. NO/DATE: EU/1/14/967 20141121
2049506 C20150046 00250 Estonia   Start Trial PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
3150586 PA2020508 Lithuania   Start Trial PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Colorcon
Express Scripts
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.