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Last Updated: November 22, 2024

Misoprostol - Generic Drug Details


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

Misoprostol is the generic ingredient in two branded drugs marketed by Pfizer, Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc, and is included in five 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.

Summary for misoprostol
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 Maryland, BaltimoreEarly Phase 1
Kazakhstan's Medical University "KSPH"Phase 4
Asfendiyarov Kazakh National Medical UniversityPhase 4

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
Acq Pharma MISOPROSTOL misoprostol TABLET;ORAL 210201-002 Jul 2, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novel Labs Inc MISOPROSTOL misoprostol TABLET;ORAL 091667-001 Jul 25, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms MISOPROSTOL misoprostol TABLET;ORAL 076095-002 Jul 10, 2002 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novel Labs Inc MISOPROSTOL misoprostol TABLET;ORAL 091667-002 Jul 25, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acq Pharma MISOPROSTOL misoprostol TABLET;ORAL 210201-001 Jul 2, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990 ⤷  Sign Up ⤷  Sign Up
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ⤷  Sign Up ⤷  Sign Up
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ⤷  Sign Up ⤷  Sign Up
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ⤷  Sign Up ⤷  Sign Up
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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