AGENERASE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Agenerase, 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 |
>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 |
---|---|---|---|
Brazil | 9708238 | ⤷ Try a Trial | |
Estonia | 04307 | Aspartüüli proteaasi THF-i sisaldavad sulfoonamiidinhibiitorid | ⤷ Try a Trial |
China | 1061339 | ⤷ Try a Trial | |
United Kingdom | 9606372 | ⤷ Try a Trial | |
Hungary | 228026 | COMPOSITIONS COMPRISING AN HIV PROTEASE INHIBITOR AND A WATER SOLUBLE VITAMIN E COMPOUND | ⤷ Try a Trial |
Canada | 2143208 | INHIBITEURS DE TYPE SULONAMIDE DE L'ASPARTYL-PROTEASE DU VIH (SULFONAMIDE INHIBITORS OF HIV-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 |
---|---|---|---|---|
0659181 | 5/2001 | Austria | ⤷ Try a Trial | PRODUCT NAME: AMPRENAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/00/148/001 - EU/1/00/148/004 20001020; FIRST REGISTRATION: LI 55072 01, 55072 02 UND 55073 01 19990512 |
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 |
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 | PA2008006 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
0933372 | PA2008006,C0933372 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
0659181 | SPC004/2001 | Ireland | ⤷ Try a Trial | SPC004/2001: 20050808, EXPIRES: 20140511 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |