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Profile for Tradename: AGENERASE

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Agenerase is a drug marketed by Glaxosmithkline and is included in two NDAs. There are three patents protecting this drug.

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

The generic ingredient in AGENERASE is amprenavir. There are five drug master file entries for this compound. Additional details are available on the amprenavir profile page.

Summary for Tradename: AGENERASE

Patents:3
Applicants:1
NDAs:2

Clinical Trials for: AGENERASE

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, 1999DISCNNo5,646,180<disabled><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>
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 1999DISCNNo5,723,490<disabled><disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 1999DISCNNo5,723,490<disabled><disabled>
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Non-Orange Book Patents for Tradename: AGENERASE

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 Tradename: AGENERASE

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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