MONISTAT 3 Drug Patent Profile
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When do Monistat 3 patents expire, and when can generic versions of Monistat 3 launch?
Monistat 3 is a drug marketed by Medtech Products and is included in four NDAs.
The generic ingredient in MONISTAT 3 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat 3
A generic version of MONISTAT 3 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MONISTAT 3?
- What are the global sales for MONISTAT 3?
- What is Average Wholesale Price for MONISTAT 3?
Summary for MONISTAT 3
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 238 |
Clinical Trials: | 1 |
Patent Applications: | 2,906 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in MONISTAT 3? | MONISTAT 3 excipients list |
DailyMed Link: | MONISTAT 3 at DailyMed |
![MONISTAT 3 drug patent expirations Drug patent expirations by year for MONISTAT 3](/p/graph/s/t/MONISTAT_3-patent-expirations.png)
![Drug Sales Revenue Trends for MONISTAT 3](/p/graph/drug-sales-revenues/MONISTAT+3.png)
Recent Clinical Trials for MONISTAT 3
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital Central "Dr. Ignacio Morones Prieto" | Phase 4 |
Universidad Autonoma de San Luis Potosà | Phase 4 |
Pharmacology for MONISTAT 3
Drug Class | Azole Antifungal |
US Patents and Regulatory Information for MONISTAT 3
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 3 | miconazole nitrate | CREAM;VAGINAL | 020827-001 | Mar 30, 1998 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Medtech Products | MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 021261-003 | Jun 17, 2003 | OTC | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | AB | RX | Yes | Yes | ⤷ 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 MONISTAT 3
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MONISTAT 3
See the table below for patents covering MONISTAT 3 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 126180 | ⤷ Sign Up | |
Denmark | 579675 | ⤷ Sign Up | |
Israel | 32840 | 1-(BETA-ARYL-ETHYL)-IMIDAZOLE ETHERS AND AMINES | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |