FUZEON Drug Patent Profile
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Which patents cover Fuzeon, and what generic alternatives are available?
Fuzeon is a drug marketed by Roche and is included in one NDA.
The generic ingredient in FUZEON is enfuvirtide. One supplier is listed for this compound. Additional details are available on the enfuvirtide profile page.
Summary for FUZEON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 19 |
| Clinical Trials: | 24 |
| Patent Applications: | 5,864 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FUZEON |
| What excipients (inactive ingredients) are in FUZEON? | FUZEON excipients list |
| DailyMed Link: | FUZEON at DailyMed |
Recent Clinical Trials for FUZEON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Early Phase 1 |
| Sidney Kimmel Comprehensive Cancer Center | Early Phase 1 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for FUZEON
US Patents and Regulatory Information for FUZEON
| 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 | ⤷ 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 FUZEON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Roche | FUZEON | enfuvirtide | INJECTABLE;SUBCUTANEOUS | 021481-001 | Mar 13, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FUZEON
| 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 |
International Patents for FUZEON
See the table below for patents covering FUZEON around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2238674 | ⤷ Try a Trial | |
| European Patent Office | 0831873 | ⤷ Try a Trial | |
| Japan | H08511525 | ⤷ Try a Trial | |
| Japan | 2006176529 | METHODS AND COMPOSITIONS FOR INHIBITION OF MEMBRANE FUSION-ASSOCIATED EVENTS, INCLUDING HIV TRANSMISSION | ⤷ Try a Trial |
| Germany | 69434335 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FUZEON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0774971 | C300192 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ENFUVIRTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER; NAT. REGISTRATION NO/DATE: EU/1/03/252/001EU/1/03/252/002EU/1/03/252/003 2003270527; FIRST REGISTRATION: CH/56282 20030430 |
| 0774971 | SPC/GB05/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ENFUVIRTIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; REGISTERED: CH CH 56,282 20030430; UK EU/1/03/252/001 20030527; UK EU/1/03/252/002 20030527; UK EU/1/03/252/003 20030527 |
| 0774971 | C00774971/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH |
| 0774971 | 300192 | Netherlands | ⤷ Try a Trial | 300192, 20140607, EXPIRES: 20180429 |
| 0774971 | CA 2005 00042 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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