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: | 449 |
| 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 |
|---|---|
| French Ministry of Social Affairs and Health | N/A |
| University Hospital, Bordeaux | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | MISOPROSTOL | misoprostol | TABLET;ORAL | 076095-001 | Jul 10, 2002 | AB | RX | 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 | ||||
| Novel Labs Inc | MISOPROSTOL | misoprostol | TABLET;ORAL | 091667-002 | 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 | |||
| Micro Labs | MISOPROSTOL | misoprostol | TABLET;ORAL | 216872-001 | Oct 17, 2022 | AB | RX | No | 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 | |||
| Acq Pharma | MISOPROSTOL | misoprostol | TABLET;ORAL | 210201-001 | 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 |
Expired US Patents for misoprostol
| 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 |
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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