MISOPROSTOL Drug Patent Profile
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Which patents cover Misoprostol, and when can generic versions of Misoprostol launch?
Misoprostol is a drug marketed by Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc. and is included in four NDAs.
The generic ingredient in MISOPROSTOL 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 Misoprostol
A generic version of MISOPROSTOL was approved as misoprostol by ANI PHARMS on July 10th, 2002.
Summary for MISOPROSTOL
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 449 |
Patent Applications: | 6,382 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MISOPROSTOL |
What excipients (inactive ingredients) are in MISOPROSTOL? | MISOPROSTOL excipients list |
DailyMed Link: | MISOPROSTOL at DailyMed |
Recent Clinical Trials for MISOPROSTOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital, Bordeaux | N/A |
French Ministry of Social Affairs and Health | N/A |
Planned Parenthood League of Massachusetts | Phase 3 |
Pharmacology for MISOPROSTOL
Drug Class | Prostaglandin E1 Analog |
Medical Subject Heading (MeSH) Categories for MISOPROSTOL
Anatomical Therapeutic Chemical (ATC) Classes for MISOPROSTOL
US Patents and Regulatory Information for MISOPROSTOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acq Pharma | MISOPROSTOL | misoprostol | TABLET;ORAL | 210201-001 | Jul 2, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novel Labs Inc | MISOPROSTOL | misoprostol | TABLET;ORAL | 091667-001 | Jul 25, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ani Pharms | MISOPROSTOL | misoprostol | TABLET;ORAL | 076095-002 | Jul 10, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novel Labs Inc | MISOPROSTOL | misoprostol | TABLET;ORAL | 091667-002 | Jul 25, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acq Pharma | MISOPROSTOL | misoprostol | TABLET;ORAL | 210201-002 | Jul 2, 2019 | DISCN | No | 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 |