FOSAMPRENAVIR CALCIUM Drug Patent Profile
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Which patents cover Fosamprenavir Calcium, and what generic alternatives are available?
Fosamprenavir Calcium is a drug marketed by Mylan and Sun Pharm and is included in two NDAs.
The generic ingredient in FOSAMPRENAVIR CALCIUM is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fosamprenavir Calcium
A generic version of FOSAMPRENAVIR CALCIUM was approved as fosamprenavir calcium by MYLAN on April 15th, 2016.
Summary for FOSAMPRENAVIR CALCIUM
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | FOSAMPRENAVIR CALCIUM | fosamprenavir calcium | TABLET;ORAL | 204024-001 | Nov 20, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
