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MONISTAT 7 Drug Profile
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Which patents cover Monistat 7, and when can generic versions of Monistat 7 launch?
Monistat 7 is a drug marketed by Medtech Products and is included in three NDAs.
The generic ingredient in MONISTAT 7 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
US ANDA Litigation and Generic Entry Outlook for Monistat 7
A generic version of MONISTAT 7 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.
Summary for MONISTAT 7
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,707 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MONISTAT 7 at DailyMed |
Recent Clinical Trials for MONISTAT 7
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto" | Phase 4 |
| Universidad Autonoma de San Luis Potosí | Phase 4 |
US Patents and Regulatory Information for MONISTAT 7
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medtech Products | MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450-002 | Feb 15, 1991 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Medtech Products | MONISTAT 7 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018520-002 | Feb 15, 1991 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Medtech Products | MONISTAT 7 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020288-002 | Apr 26, 1993 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MONISTAT 7
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czechoslovakia | 184772 | Start Trial |
| U.S.S.R. | 557755 | Start Trial |
| France | 2081427 | Start Trial |
| Czechoslovakia | 184753 | Start Trial |
| Brazil | 6911658 | Start Trial |
| Japan | S51115 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
