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Last Updated: August 4, 2020

DrugPatentWatch Database Preview

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. There is one patent protecting this drug.

This drug has sixteen patent family members in thirteen countries.

The generic ingredient in MONISTAT 1 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 1 Combination Pack

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

  Start Trial

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
Hospital Central "Dr. Ignacio Morones Prieto"Phase 4
Universidad Autonoma de San Luis PotosíPhase 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   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Premature patent expiration for: MONISTAT 1 COMBINATION PACK

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
  Start Trial MONISTAT 1 COMBINATION PACK   Start Trial

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Baxter
Johnson and Johnson
Merck
McKesson

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