FOSAMPRENAVIR CALCIUM - Generic Drug Details
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What are the generic sources for fosamprenavir calcium and what is the scope of patent protection?
Fosamprenavir calcium
is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Mylan, and Sun Pharm, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for fosamprenavir calcium. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FOSAMPRENAVIR CALCIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 2 |
Patent Applications: | 782 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSAMPRENAVIR CALCIUM |
What excipients (inactive ingredients) are in FOSAMPRENAVIR CALCIUM? | FOSAMPRENAVIR CALCIUM excipients list |
DailyMed Link: | FOSAMPRENAVIR CALCIUM at DailyMed |
Recent Clinical Trials for FOSAMPRENAVIR CALCIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
PENTA Foundation | Phase 2/Phase 3 |
Generic filers with tentative approvals for FOSAMPRENAVIR CALCIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 700MG | TABLET;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 FOSAMPRENAVIR CALCIUM
Drug Class | Protease Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inducers |
Anatomical Therapeutic Chemical (ATC) Classes for FOSAMPRENAVIR CALCIUM
Paragraph IV (Patent) Challenges for FOSAMPRENAVIR CALCIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LEXIVA | Tablets | fosamprenavir calcium | 700 mg | 021548 | 1 | 2012-01-18 |
US Patents and Regulatory Information for FOSAMPRENAVIR CALCIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | FOSAMPRENAVIR CALCIUM | fosamprenavir calcium | TABLET;ORAL | 204060-001 | Apr 15, 2016 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | FOSAMPRENAVIR CALCIUM | fosamprenavir calcium | TABLET;ORAL | 204024-001 | Nov 20, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Viiv Hlthcare | LEXIVA | fosamprenavir calcium | SUSPENSION;ORAL | 022116-001 | Jun 14, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | DISCN | Yes | 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 FOSAMPRENAVIR CALCIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | LEXIVA | fosamprenavir calcium | SUSPENSION;ORAL | 022116-001 | Jun 14, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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