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Details for Generic Name: amprenavir

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Amprenavir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-five patent family members in fifty countries.

There are five drug master file entries for amprenavir.

Summary for Generic Name: amprenavir

Tradenames:1
Patents:3
Applicants:1
NDAs:2
Drug Master File Entries: see list5
Formulation / Manufacturing:see details

Clinical Trials for: amprenavir

Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine, Abacavir and Amprenavir in HIV-1 Infected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Naive Adults
Status: Terminated Condition: HIV Infections

Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.
Status: Completed Condition: HIV Infections

A Study of Amprenavir in HIV-Infected Patients
Status: Completed Condition: HIV Infections

A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
Status: Completed Condition: HIV Infections

A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
Status: Completed Condition: HIV Infections

A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
Status: Completed Condition: HIV Infections

Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz
Status: Completed Condition: HIV Infection

Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers
Status: Completed Condition: HIV Infections

A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications
Status: Completed Condition: HIV Infections

A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
Status: Completed Condition: HIV Infections

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 1999DISCNNo5,723,490<disabled><disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 1999DISCNNo5,723,490<disabled><disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 1999DISCNNo6,730,679<disabled>Y<disabled>
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 1999DISCNNo5,646,180<disabled><disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 1999DISCNNo5,646,180<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: amprenavir

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,977,137 Sulfonamide inhibitors of aspartyl protease<disabled in preview>
5,585,397 Sulfonamide inhibitors of aspartyl protease<disabled in preview>
6,004,957 Sulfonamide inhibitors of aspartyl protease<disabled in preview>
6,720,335 Sulfonamide inhibitors of aspartyl protease<disabled in preview>
7,321,063Sulfonamide inhibitors of aspartyl protease<disabled in preview>
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International Patent Family for Ingredient: amprenavir

Country Document Number Publication Date
Germany10199024Jul 12, 2001
Germany69623298Sep 11, 2003
Georgia, Republic ofP20012579Aug 10, 2001
Norway950876May 08, 1995
Romania119923Jun 30, 2005
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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