CYTOTEC Drug Patent Profile

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Which patents cover Cytotec, and what generic alternatives are available?

Cytotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cytotec

A generic version of CYTOTEC was approved as misoprostol by ANI PHARMS on July 10^th, 2002.

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Summary for CYTOTEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	106
Patent Applications:	6,382
Drug Prices:	Drug price information for CYTOTEC
What excipients (inactive ingredients) are in CYTOTEC?	CYTOTEC excipients list
DailyMed Link:	CYTOTEC at DailyMed

Drug patent expirations by year for CYTOTEC

Recent Clinical Trials for CYTOTEC

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

Sponsor	Phase
Stanford University	Phase 3
Cairo University	N/A
University of Texas at Austin	Phase 4

See all CYTOTEC clinical trials

Pharmacology for CYTOTEC

Drug Class	Prostaglandin E1 Analog

US Patents and Regulatory Information for CYTOTEC

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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
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	AB	RX	Yes	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 CYTOTEC

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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

International Patents for CYTOTEC

See the table below for patents covering CYTOTEC around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	128075		⤷ Sign Up
Canada	1040197	DERIVES D'ACIDE PROSTANOIQUE OXYGENE EN 16 (16-OXYGENATED PROSTANOIC ACID DERIVATIVES)	⤷ Sign Up
Germany	2513212		⤷ Sign Up
Austria	351684		⤷ Sign Up
Hungary	174973	SPOSOB POLUCHENIJA PROIZVODNYKH 16-ALKIL-16-GIDROKSI-PROSTANOVYKH KISLOT (PROCESS FOR PREPARING 16-ALKYL-16-HYDROXY-PROSTANOIC ACID DERIVATIVES)	⤷ Sign Up
Israel	46919	16-HYDROXY-16-ALKYL PROSTANOIC ACID DERIVATIVES AND THEIR PREPARATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for CYTOTEC

Recent Clinical Trials for CYTOTEC

Pharmacology for CYTOTEC

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