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Last Updated: January 27, 2023

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, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol, and is included in eleven 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-one drug master file entries for atazanavir sulfate. Eleven 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
ViiV HealthcarePhase 4
GlaxoSmithKlinePhase 4

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Generic filers with tentative approvals for ATAZANAVIR SULFATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing300MG/100MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing200MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing150MGCAPSULE; 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 Strength NDA ANDAs Submitted Submissiondate
REYATAZ Capsules atazanavir sulfate 100 mg and 150 mg 021567 1 2010-03-19
REYATAZ Capsules atazanavir sulfate 200 mg 021567 1 2010-02-16
REYATAZ Capsules atazanavir sulfate 300 mg 021567 1 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 210575-002 Jun 4, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626-004 Aug 9, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 POWDER;ORAL 206352-001 Jun 2, 2014 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for atazanavir sulfate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Reyataz atazanavir sulfate EMEA/H/C/000494
Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).
Authorised no no no 2004-03-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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