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.
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Summary for AGENERASE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 3 |
| Patent Applications: | 5,393 |
| 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 Institutes of Health (NIH) | Phase 2/Phase 3 |
| National Institute of Mental Health (NIMH) | Phase 2/Phase 3 |
| University of California, San Diego | Phase 2/Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-002 | Apr 15, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | AGENERASE | amprenavir | SOLUTION;ORAL | 021039-001 | Apr 15, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-002 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-001 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-002 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | SOLUTION;ORAL | 021039-001 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-001 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Austria | 279922 | ⤷ Sign Up | |
| Austria | 230602 | ⤷ Sign Up | |
| African Regional IP Organization (ARIPO) | 9300572 | ⤷ Sign Up | |
| Czech Republic | 291994 | ⤷ Sign Up | |
| Iceland | 4574 | ⤷ Sign Up | |
| Denmark | 0906107 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AGENERASE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0659181 | SPC004/2001 | Ireland | ⤷ Sign Up | SPC004/2001: 20050808, EXPIRES: 20140511 |
| 0933372 | 13/2008 | Austria | ⤷ Sign Up | 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 | PA2008006,C0933372 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
| 0659181 | 5/2001 | Austria | ⤷ Sign Up | 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 |
| 0933372 | PA2008006 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
| 0659181 | CA 2001 00007 | Denmark | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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