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. Fifteen 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 10th, 2002.
Summary for CYTOTEC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 104 |
Patent Applications: | 6,320 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CYTOTEC |
What excipients (inactive ingredients) are in CYTOTEC? | CYTOTEC excipients list |
DailyMed Link: | CYTOTEC at DailyMed |
Recent Clinical Trials for CYTOTEC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Texas at Austin | Phase 4 |
University of North Carolina, Chapel Hill | Phase 2 |
Karolinska Institutet | Phase 3 |
Pharmacology for CYTOTEC
Drug Class | Prostaglandin E1 Analog |
Anatomical Therapeutic Chemical (ATC) Classes for CYTOTEC
US Patents and Regulatory Information for CYTOTEC
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | AB | RX | Yes | Yes | ⤷ 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 CYTOTEC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-003 | Sep 21, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Netherlands | 930058 | ⤷ Try a Trial | |
Germany | 3463613 | ⤷ Try a Trial | |
South Africa | 7501391 | ⤷ Try a Trial | |
Argentina | 207355 | UN PROCEDIMIENTO PARA LA PREPARACION DE DERIVADOS DEL ACIDO 7-(-(4-HIDROXI-4-ALQUIL-1-ALQUENIL)CICLOPENTANO)-1-HEPTANOICO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |