Misoprostol - Generic Drug Details
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What are the generic drug sources for misoprostol and what is the scope of patent protection?
Misoprostol
is the generic ingredient in two branded drugs marketed by Pfizer, Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for misoprostol. Fifteen suppliers are listed for this compound.
Summary for misoprostol
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 454 |
Patent Applications: | 7,472 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms | MISOPROSTOL | misoprostol | TABLET;ORAL | 076095-001 | Jul 10, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | AB | RX | Yes | Yes | ⤷ 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 | 210201-001 | Jul 2, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Micro Labs | MISOPROSTOL | misoprostol | TABLET;ORAL | 216872-001 | Oct 17, 2022 | AB | RX | 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 | |||
>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 misoprostol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-003 | Sep 21, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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