AGENERASE Drug Patent Profile
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When do Agenerase patents expire, 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.
Summary for AGENERASE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 3 |
Patent Applications: | 4,405 |
Formulation / Manufacturing: | see details |
DailyMed Link: | AGENERASE at DailyMed |
Recent Clinical Trials for AGENERASE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Mental Health (NIMH) | Phase 2/Phase 3 |
University of California, San Diego | Phase 2/Phase 3 |
National Institutes of Health (NIH) | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for AGENERASE
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 |
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 | 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 |
---|---|---|---|
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 |
Czech Republic | 9801708 | ⤷ Try a Trial | |
Slovakia | 126998 | COMPOSITIONS COMPRISING AN HIV PROTEASE INHIBITOR SUCH AS VX 478 AND A WATER SOLUBLE VITAMIN E COMPOUND SUCH AS VITAMIN E-TPGS | ⤷ Try a Trial |
Portugal | 846110 | ⤷ 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 |
0933372 | PA2008006 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
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 |
0659181 | 2001C/014 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AMPRENAVIR; NATL. REGISTRATION NO/DATE: EU/1/00/148/001 20001020; FIRST REGISTRATION: CH 55072 01 19990512 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |