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Last Updated: March 19, 2024

Amprenavir - Generic Drug Details


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What are the generic sources for amprenavir and what is the scope of freedom to operate?

Amprenavir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for amprenavir.

Recent Clinical Trials for amprenavir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
PPDPhase 3

See all amprenavir clinical trials

US Patents and Regulatory Information for amprenavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir SOLUTION;ORAL 021039-001 Apr 15, 1999 DISCN Yes 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

Expired US Patents for amprenavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for amprenavir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Glaxo Group Ltd. Agenerase amprenavir EMEA/H/C/000264
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)
Withdrawn no no no 2000-10-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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