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Last Updated: April 17, 2021

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CLOMIPHENE CITRATE - Generic Drug Details

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What are the generic drug sources for clomiphene citrate and what is the scope of patent protection?

Clomiphene citrate is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us, Par Pharm, Granata Bio, and Emd Serono, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for clomiphene citrate. Five suppliers are listed for this compound.


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Recent Clinical Trials for CLOMIPHENE CITRATE

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

Baylor College of MedicineEarly Phase 1
Assiut UniversityEarly Phase 1
Karachi Medical and Dental CollegePhase 4

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Medical Subject Heading (MeSH) Categories for CLOMIPHENE CITRATE

US Patents and Regulatory Information for CLOMIPHENE CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm CLOMIPHENE CITRATE clomiphene citrate TABLET;ORAL 075528-001 Aug 30, 1999 RX No Yes   Start Trial   Start Trial   Start Trial
Emd Serono SEROPHENE clomiphene citrate TABLET;ORAL 018361-001 Mar 22, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us CLOMID clomiphene citrate TABLET;ORAL 016131-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Granata Bio MILOPHENE clomiphene citrate TABLET;ORAL 072196-001 Dec 20, 1988 DISCN No No   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:

Johnson and Johnson

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