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. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for ATAZANAVIR SULFATE
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 10 |
NDAs: | 11 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 1 |
Patent Applications: | 43 |
Drug Prices: | Drug price trends for ATAZANAVIR SULFATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE |
What excipients (inactive ingredients) are in ATAZANAVIR SULFATE? | ATAZANAVIR SULFATE excipients list |
DailyMed Link: | ATAZANAVIR SULFATE at DailyMed |
Recent Clinical Trials for ATAZANAVIR SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ViiV Healthcare | Phase 4 |
GlaxoSmithKline | Phase 4 |
Generic filers with tentative approvals for ATAZANAVIR SULFATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 300MG/100MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 150MG | CAPSULE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | REYATAZ | atazanavir sulfate | POWDER;ORAL | 206352-001 | Jun 2, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd Iii | ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 212278-001 | Feb 2, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 091673-002 | Apr 22, 2014 | 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 |
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 | 021567-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-002 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-003 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>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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