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.
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 |
---|---|
University of California, San Diego | Phase 2/Phase 3 |
National Institutes of Health (NIH) | Phase 2/Phase 3 |
National Institute of Mental Health (NIMH) | 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 | 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 |
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 |
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 |
>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 |
---|---|---|---|
Hungary | 9901887 | ⤷ Try a Trial | |
Poland | 187919 | ⤷ Try a Trial | |
Bulgaria | 102048 | ⤷ 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 |
New Zealand | 331645 | 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 |
Denmark | 0906107 | ⤷ Try a Trial | |
Russian Federation | 2203658 | ЛЕЧЕНИЕ ПОРАЖЕНИЯ ЦЕНТРАЛЬНОЙ НЕРВНОЙ СИСТЕМЫ, ВЫЗВАННОГО ВИЧ, С ПОМОЩЬЮ VX-478, ИЗОЛИРОВАННО ЛИБО В КОМБИНАЦИИ С AZT ИЛИ ЗТС (METHOD FOR TREATING THE CASES OF CENTRAL NERVOUS SYSTEM INJURIES CAUSED BY HIV INFECTION BY APPLYING VX-478 ONLY OR IN COMBINATION AZT OR ZTS) | ⤷ 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 | PA2008006,C0933372 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
0933372 | C00933372/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005 |
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 | 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 |
0659181 | SPC/GB01/009 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AMPRENAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: CH 5507201 19990512; CH 5507202 & 5507301 19990512; UK EU/1/00/148/001 20001020; UK EU/1/00/148/002 20001020; UK EU/1/001/148/003 20001020; UK EU/1/00/148/004 20001020 |
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 |