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Last Updated: November 2, 2024

ATAZANAVIR SULFATE Drug Patent Profile


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When do Atazanavir Sulfate patents expire, and what generic alternatives are available?

Atazanavir Sulfate is a drug marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Atazanavir Sulfate

A generic version of ATAZANAVIR SULFATE was approved as atazanavir sulfate by TEVA PHARMS USA on April 22nd, 2014.

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Drug patent expirations by year for ATAZANAVIR SULFATE
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

See all ATAZANAVIR SULFATE clinical trials

Medical Subject Heading (MeSH) Categories for ATAZANAVIR SULFATE
Anatomical Therapeutic Chemical (ATC) Classes 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 210575-003 Jun 4, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 209717-001 Jun 1, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Laurus ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 212579-003 Apr 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673-003 Apr 22, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-003 Jun 25, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 209717-004 Jun 1, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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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