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Last Updated: March 19, 2024

AGENERASE Drug Patent Profile


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When do Agenerase patents expire, and when can generic versions of Agenerase launch?

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 Institutes of Health (NIH)Phase 2/Phase 3
National Institute of Mental Health (NIMH)Phase 2/Phase 3
University of California, San DiegoPhase 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 021007-002 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
>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
Hong Kong 1012631 ⤷  Try a Trial
New Zealand 256238 SUBSTITUTED SULPHONAMIDES AND PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Turkey 9701199 ⤷  Try a Trial
Poland 185635 ⤷  Try a Trial
Brazil 9611861 ⤷  Try a Trial
Russian Federation 2135496 SULFONEAMIDE INHIBITORS OF HIV-ASPARTYLPROTEASE, PHARMACEUTICAL COMPOSITION, METHOD OF TREATMENT, METHOD OF INHIBITOR IDENTIFICATION ⤷  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 SPC/GB08/018 United Kingdom ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0933372 C00933372/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
0933372 08C0015 France ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
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
0659181 SPC004/2001 Ireland ⤷  Try a Trial SPC004/2001: 20050808, EXPIRES: 20140511
0659181 CA 2001 00007 Denmark ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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