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Last Updated: March 29, 2024

AGENERASE Drug Patent Profile


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Which patents cover Agenerase, and what generic alternatives are available?

Agenerase is a drug marketed by Glaxosmithkline and is included in two NDAs.

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.

Drug patent expirations by year for AGENERASE
Recent Clinical Trials for AGENERASE

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

SponsorPhase
National Institute of Mental Health (NIMH)Phase 2/Phase 3
University of California, San DiegoPhase 2/Phase 3
National Institutes of Health (NIH)Phase 2/Phase 3

See all AGENERASE clinical trials

US Patents and Regulatory Information for AGENERASE

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 021007-001 Apr 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 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 AGENERASE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline AGENERASE amprenavir SOLUTION;ORAL 021039-001 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 SOLUTION;ORAL 021039-001 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 AGENERASE

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

International Patents for AGENERASE

See the table below for patents covering AGENERASE around the world.

Country Patent Number Title Estimated Expiration
Argentina 006345 UNA COMPOSICION FARMACEUTICA PARA ADMINISTRACION ORAL QUE COMPRENDE UN INHIBIDOR DE PROTEASA DEL VIH Y UN DERIVADO DE TOCOFEROL SOLUBLE EN AGUA, Y UN METODO PARA PREPARAR DICHA COMPOSICION. ⤷  Try a Trial
Bulgaria 63677 ⤷  Try a Trial
Bulgaria 102838 ⤷  Try a Trial
Malaysia 142901 NOVEL SULFONAMIDE INHIBITORS OF ASPARTYL PROTEASE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AGENERASE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 13/2008 Austria ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
0933372 C00933372/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
0659181 CA 2001 00007 Denmark ⤷  Try a Trial
0933372 08C0015 France ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.