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Last Updated: May 10, 2021

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MONISTAT 1 COMBINATION PACK Drug Profile

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Which patents cover Monistat 1 Combination Pack, and when can generic versions of Monistat 1 Combination Pack launch?

Monistat 1 Combination Pack is a drug marketed by Medtech Products and is included in one NDA.

The generic ingredient in MONISTAT 1 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat 1 Combination Pack

A generic version of MONISTAT 1 COMBINATION PACK was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Summary for MONISTAT 1 COMBINATION PACK
Drug patent expirations by year for MONISTAT 1 COMBINATION PACK
Recent Clinical Trials for MONISTAT 1 COMBINATION PACK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Universidad Autonoma de San Luis PotosíPhase 4
Hospital Central "Dr. Ignacio Morones Prieto"Phase 4

See all MONISTAT 1 COMBINATION PACK clinical trials

Paragraph IV (Patent) Challenges for MONISTAT 1 COMBINATION PACK
Tradename Dosage Ingredient NDA Submissiondate
MONISTAT 1 COMBINATION PACK CREAM, SUPPOSITORY;TOPICAL, VAGINAL miconazole nitrate 021308 2007-12-05

US Patents and Regulatory Information for MONISTAT 1 COMBINATION PACK

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 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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 1 COMBINATION PACK

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MONISTAT 1 COMBINATION PACK

Country Patent Number Estimated Expiration
Japan 2002530327   Get Started for $10
Taiwan I229599   Get Started for $10
South Korea 20010034150   Get Started for $10
Canada 2318125   Get Started for $10
World Intellectual Property Organization (WIPO) 0030626   Get Started for $10
Argentina 021863   Get Started for $10
China 1332663   Get Started for $10
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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