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Last Updated: October 26, 2021

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Atazanavir sulfate - Generic Drug Details

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

Atazanavir sulfate is the generic ingredient in three branded drugs marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Laurus Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol-myers Squibb, and is included in ten NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for atazanavir sulfate. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for atazanavir sulfate

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Recent Clinical Trials for atazanavir sulfate

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

SponsorPhase
GlaxoSmithKlinePhase 4
ViiV HealthcarePhase 4

See all atazanavir sulfate clinical trials

Generic filers with tentative approvals for ATAZANAVIR SULFATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial300MG/100MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial200MGCAPSULE; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial150MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for atazanavir sulfate
Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE
Tradename Dosage Ingredient NDA Submissiondate
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2010-03-19
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2010-02-16
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2009-07-20

US Patents and Regulatory Information for atazanavir sulfate

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Teva Pharms Usa ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673-002 Apr 22, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 210575-002 Jun 4, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cipla ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626-004 Aug 9, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Baxter
McKesson
McKinsey
Merck

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