ENFUVIRTIDE - Generic Drug Details
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What are the generic drug sources for enfuvirtide and what is the scope of patent protection?
Enfuvirtide
is the generic ingredient in one branded drug marketed by Roche and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for ENFUVIRTIDE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 19 |
| Clinical Trials: | 51 |
| Patent Applications: | 7,260 |
| What excipients (inactive ingredients) are in ENFUVIRTIDE? | ENFUVIRTIDE excipients list |
| DailyMed Link: | ENFUVIRTIDE at DailyMed |
Recent Clinical Trials for ENFUVIRTIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Orlando Immunology Center | Phase 4 |
| ViiV Healthcare | Phase 4 |
| University of Washington | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ENFUVIRTIDE
US Patents and Regulatory Information for ENFUVIRTIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | RX | Yes | Yes | ⤷ 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 ENFUVIRTIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ENFUVIRTIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Roche Registration GmbH | Fuzeon | enfuvirtide | EMEA/H/C/000514 Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate. |
Authorised | no | no | no | 2003-05-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
