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 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Hospital Universitario 12 de Octubre | Phase 3 |
Spanish Clinical Research Network - SCReN | Phase 3 |
Instituto de Salud Carlos III | Phase 3 |
Pharmacology for dinoprostone
Drug Class | Prostaglandin Analog |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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
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 | ⤷ Sign Up | ⤷ Sign Up |
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 | 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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