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 |
---|---|---|---|
Finland | 751886 | ⤷ Try a Trial | |
Sweden | 394432 | IMIDAZOLDERIVAT TILL ANVENDNING FOR BEKEMPNING AV SVAMPAR | ⤷ Try a Trial |
Austria | 299194 | ⤷ Try a Trial | |
United Kingdom | 1318590 | ⤷ Try a Trial | |
Denmark | 137947 | ⤷ Try a Trial | |
Italy | 974527 | PROCEDIMENTO PER LA PRODUZIONE DI DERIVATI DELLO IMIDAZOL | ⤷ Try a Trial |
Denmark | 140213 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |