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Last Updated: August 12, 2020

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AGENERASE Drug 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.

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

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

SponsorPhase
University of California, San DiegoPhase 2/Phase 3
National Institute of Mental Health (NIMH)Phase 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   Start Trial   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir SOLUTION;ORAL 021039-001 Apr 15, 1999 DISCN Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-002 Apr 15, 1999   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir SOLUTION;ORAL 021039-001 Apr 15, 1999   Start Trial   Start Trial
Glaxosmithkline AGENERASE amprenavir CAPSULE;ORAL 021007-001 Apr 15, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AGENERASE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 PA2008006 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0659181 CA 2001 00007 Denmark   Start Trial
0933372 C00933372/01 Switzerland   Start Trial PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
0933372 SPC/GB08/018 United Kingdom   Start 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 08C0015 France   Start 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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