MONISTAT Drug Patent Profile
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Which patents cover Monistat, and when can generic versions of Monistat launch?
Monistat is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms. and is included in twelve NDAs.
The generic ingredient in MONISTAT 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat
A generic version of MONISTAT was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.
Summary for MONISTAT
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,220 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MONISTAT at DailyMed |
Recent Clinical Trials for MONISTAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad Autonoma de San Luis Potosí | Phase 4 |
| Hospital Central "Dr. Ignacio Morones Prieto" | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for MONISTAT
US Patents and Regulatory Information for MONISTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medtech Products | MONISTAT 3 COMBINATION PACK (PREFILLED) | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 021261-001 | Feb 2, 2001 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | CREAM;TOPICAL | 017494-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Personal Prods | MONISTAT 5 | miconazole nitrate | TAMPON;VAGINAL | 018592-001 | Oct 27, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medtech Products | MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308-001 | Jun 29, 2001 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medtech Products | MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827-001 | Mar 30, 1998 | OTC | Yes | Yes | ⤷ 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 MONISTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MONISTAT
See the table below for patents covering MONISTAT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czechoslovakia | 184771 | METHOD FOR PRODUCING IMIDAZOLE DERIVATIVES | ⤷ Try a Trial |
| Romania | 56625 | ⤷ Try a Trial | |
| United Kingdom | 1244530 | ⤷ Try a Trial | |
| U.S.S.R. | 408476 | ⤷ Try a Trial | |
| Finland | 52858 | ⤷ Try a Trial | |
| Denmark | 139255 | ⤷ Try a Trial | |
| African Intellectual Property Organization (OAPI) | 3898 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated 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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