DINOPROSTONE - Generic Drug Details

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What are the generic sources for dinoprostone and what is the scope of freedom to operate?

Dinoprostone is the generic ingredient in three branded drugs marketed by Pfizer and Ferring Pharms Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dinoprostone. Two suppliers are listed for this compound.

Summary for DINOPROSTONE

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	80
Patent Applications:	7,560
What excipients (inactive ingredients) are in DINOPROSTONE?	DINOPROSTONE excipients list
DailyMed Link:	DINOPROSTONE at DailyMed

Recent Clinical Trials for DINOPROSTONE

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

Sponsor	Phase
Spanish Clinical Research Network - SCReN	Phase 3
Instituto de Salud Carlos III	Phase 3
Hospital Universitario 12 de Octubre	Phase 3

See all DINOPROSTONE clinical trials

Pharmacology for DINOPROSTONE

Drug Class	Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for DINOPROSTONE

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for DINOPROSTONE

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

US Patents and Regulatory Information for DINOPROSTONE

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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
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992		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 DINOPROSTONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	⤷ Sign Up	⤷ Sign Up
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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