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
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
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3

See all FOSAMPRENAVIR CALCIUM clinical trials

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

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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

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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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