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Last Updated: January 16, 2021

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Miltefosine - Generic Drug Details

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What are the generic drug sources for miltefosine and what is the scope of freedom to operate?

Miltefosine is the generic ingredient in one branded drug marketed by Knight Theraps and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for miltefosine
Recent Clinical Trials for miltefosine

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

Universidad de AntioquiaPhase 1/Phase 2
Hospital Dermatológico de JorochitoPhase 2/Phase 3
Ministerio de Salud de Bolivia, Programa Nacional de LeishmaniasisPhase 2/Phase 3

See all miltefosine clinical trials

US Patents and Regulatory Information for miltefosine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Knight Theraps IMPAVIDO miltefosine CAPSULE;ORAL 204684-001 Mar 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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