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Last Updated: March 28, 2024

ENFUVIRTIDE - Generic Drug Details


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What are the generic 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
Recent Clinical Trials for ENFUVIRTIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 4
Orlando Immunology CenterPhase 4
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de FannPhase 4

See all ENFUVIRTIDE clinical trials

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 ⤷  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 ENFUVIRTIDE

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 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

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