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Last Updated: March 29, 2024

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
Instituto de Salud Carlos IIIPhase 3
Hospital Universitario 12 de OctubrePhase 3
Spanish Clinical Research Network - SCReNPhase 3

See all dinoprostone clinical trials

Pharmacology for dinoprostone
Medical Subject Heading (MeSH) Categories for dinoprostone
Anatomical Therapeutic Chemical (ATC) Classes 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
Pfizer PREPIDIL dinoprostone GEL;ENDOCERVICAL 019617-001 Dec 9, 1992 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ferring Pharms Inc CERVIDIL dinoprostone INSERT, EXTENDED RELEASE;VAGINAL 020411-001 Mar 30, 1995 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 PREPIDIL dinoprostone GEL;ENDOCERVICAL 019617-001 Dec 9, 1992 ⤷  Try a Trial ⤷  Try a Trial
Pfizer PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Pfizer PREPIDIL dinoprostone GEL;ENDOCERVICAL 019617-001 Dec 9, 1992 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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