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 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

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	455
Patent Applications:	7,472
Drug Prices:	Drug price trends for MISOPROSTOL
What excipients (inactive ingredients) are in MISOPROSTOL?	MISOPROSTOL excipients list
DailyMed Link:	MISOPROSTOL at DailyMed

See drug prices for MISOPROSTOL

Drug Sales Revenue Trends for MISOPROSTOL

See drug sales revenues for MISOPROSTOL

Recent Clinical Trials for MISOPROSTOL

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

Sponsor	Phase
University of Maryland, Baltimore	Early Phase 1
Kazakhstan's Medical University "KSPH"	Phase 4
Asfendiyarov Kazakh National Medical University	Phase 4

See all MISOPROSTOL clinical trials

Pharmacology for MISOPROSTOL

Drug Class	Prostaglandin E1 Analog

Medical Subject Heading (MeSH) Categories for MISOPROSTOL

Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for MISOPROSTOL

A02BB	Prostaglandins
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for MISOPROSTOL

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Glossary

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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		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	MISOPROSTOL	misoprostol	TABLET;ORAL	216872-002	Oct 17, 2022	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Sign Up	⤷ Sign Up
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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