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Last Updated: August 13, 2020

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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, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol-myers Squibb, and is included in nine 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. Ten 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

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SponsorPhase
GlaxoSmithKlinePhase 4
ViiV HealthcarePhase 4

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Generic filers with tentative approvals for ATAZANAVIR SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MG/100MGTABLET; ORAL
  Start Trial  Start Trial200MGCAPSULE; ORAL
  Start Trial  Start 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
Zydus Pharms ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 210575-001 Jun 4, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 209717-002 Jun 1, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-003 Jun 25, 2018 AB RX No No   Start Trial   Start Trial   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003   Start Trial   Start Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003   Start Trial   Start Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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