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.

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

Sponsor

Phase

University of Maryland, Baltimore

Early Phase 1

Asfendiyarov Kazakh National Medical University

Phase 4

Kazakhstan's Medical University "KSPH"

Phase 4

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
Ani Pharms	MISOPROSTOL	misoprostol	TABLET;ORAL	076095-002	Jul 10, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	MISOPROSTOL	misoprostol	TABLET;ORAL	216872-001	Oct 17, 2022	AB	RX	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

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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
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

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

TABLET;ORAL

Dec 27, 1988

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TABLET;ORAL

Sep 21, 1990

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TABLET;ORAL

Dec 27, 1988

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TABLET;ORAL

Dec 27, 1988

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TABLET;ORAL

Dec 27, 1988

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>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

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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

Misoprostol - Generic Drug Details

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

Summary for misoprostol

Recent Clinical Trials for misoprostol

Pharmacology for misoprostol

Medical Subject Heading (MeSH) Categories for misoprostol

Anatomical Therapeutic Chemical (ATC) Classes for misoprostol

US Patents and Regulatory Information for misoprostol

Expired US Patents for misoprostol

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