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Last Updated: August 3, 2021

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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
Recent Clinical Trials for dinoprostone

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

SponsorPhase
University Medical Centre MariborPhase 4
Aswan University HospitalN/A
Intermountain Health Care, Inc.Phase 3

See all dinoprostone clinical trials

Pharmacology for dinoprostone
Medical Subject Heading (MeSH) Categories for dinoprostone

US Patents and Regulatory Information for dinoprostone

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer PREPIDIL dinoprostone GEL;ENDOCERVICAL 019617-001 Dec 9, 1992 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

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

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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Medtronic
Baxter
Express Scripts
Dow

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