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Last Updated: August 10, 2020

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MISOPROSTOL - Generic Drug Details

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What are the generic sources for misoprostol and what is the scope of patent protection?

Misoprostol is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Ani Pharms Inc, Novel Labs Inc, and Zydus Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for misoprostol. Sixteen suppliers are listed for this compound.

Drug Prices for MISOPROSTOL

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Drug Sales Revenue Trends for MISOPROSTOL

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Recent Clinical Trials for MISOPROSTOL

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

SponsorPhase
University of Wisconsin, MadisonEarly Phase 1
Suez Canal UniversityEarly Phase 1
Aljazeera HospitalEarly Phase 1

See all MISOPROSTOL clinical trials

Pharmacology for MISOPROSTOL
Medical Subject Heading (MeSH) Categories for MISOPROSTOL

US Patents and Regulatory Information for MISOPROSTOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc MISOPROSTOL misoprostol TABLET;ORAL 091667-001 Jul 25, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms MISOPROSTOL misoprostol TABLET;ORAL 210201-001 Jul 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc MISOPROSTOL misoprostol TABLET;ORAL 076095-001 Jul 10, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms MISOPROSTOL misoprostol TABLET;ORAL 210201-002 Jul 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc MISOPROSTOL misoprostol TABLET;ORAL 091667-002 Jul 25, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990 AB RX Yes 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

Expired US Patents for MISOPROSTOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Express Scripts
Dow

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