AMPRENAVIR - Generic Drug Details
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What are the generic drug sources for amprenavir and what is the scope of freedom to operate?
Amprenavir
is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for amprenavir.
Summary for AMPRENAVIR
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 63 |
| Patent Applications: | 8,175 |
| DailyMed Link: | AMPRENAVIR at DailyMed |
Recent Clinical Trials for AMPRENAVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| PPD | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for AMPRENAVIR
US Patents and Regulatory Information for AMPRENAVIR
| 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 | 021007-002 | 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 | ||||
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-001 | Apr 15, 1999 | DISCN | No | 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 AMPRENAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | AGENERASE | amprenavir | SOLUTION;ORAL | 021039-001 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | CAPSULE;ORAL | 021007-002 | Apr 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | AGENERASE | amprenavir | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AMPRENAVIR
| 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 |
