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Last Updated: September 25, 2020

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MONISTAT 3 COMBINATION PACK Drug Profile

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Which patents cover Monistat 3 Combination Pack, and what generic alternatives are available?

Monistat 3 Combination Pack is a drug marketed by Medtech Products and is included in two NDAs.

The generic ingredient in MONISTAT 3 COMBINATION PACK 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 3 Combination Pack

A generic version of MONISTAT 3 COMBINATION PACK was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Drug patent expirations by year for MONISTAT 3 COMBINATION PACK
Recent Clinical Trials for MONISTAT 3 COMBINATION PACK

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

See all MONISTAT 3 COMBINATION PACK clinical trials

US Patents and Regulatory Information for MONISTAT 3 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 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Boehringer Ingelheim
Harvard Business School
Colorcon
Johnson and Johnson

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