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.
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Questions you can ask:
- What is the 5 year forecast for MISOPROSTOL?
- What are the global sales for MISOPROSTOL?
- What is Average Wholesale Price for MISOPROSTOL?
Summary for MISOPROSTOL
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 454 |
| 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 |
See drug prices for MISOPROSTOL
Recent Clinical Trials for MISOPROSTOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Asfendiyarov Kazakh National Medical University | Phase 4 |
| Kazakhstan's Medical University "KSPH" | Phase 4 |
| French Ministry of Social Affairs and Health | N/A |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novel Labs Inc | MISOPROSTOL | misoprostol | TABLET;ORAL | 091667-001 | Jul 25, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | MISOPROSTOL | misoprostol | TABLET;ORAL | 076095-002 | Jul 10, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novel Labs Inc | MISOPROSTOL | misoprostol | TABLET;ORAL | 091667-002 | Jul 25, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acq Pharma | MISOPROSTOL | misoprostol | TABLET;ORAL | 210201-002 | Jul 2, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | MISOPROSTOL | misoprostol | TABLET;ORAL | 076095-001 | Jul 10, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | MISOPROSTOL | misoprostol | TABLET;ORAL | 216872-002 | Oct 17, 2022 | AB | RX | No | No | ⤷ 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 |
