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Last Updated: November 4, 2024

MONISTAT-DERM Drug Patent Profile


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Which patents cover Monistat-derm, and when can generic versions of Monistat-derm launch?

Monistat-derm is a drug marketed by Insight Pharms and is included in two NDAs.

The generic ingredient in MONISTAT-DERM is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat-derm

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

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Summary for MONISTAT-DERM
Drug patent expirations by year for MONISTAT-DERM
Recent Clinical Trials for MONISTAT-DERM

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-DERM clinical trials

US Patents and Regulatory Information for MONISTAT-DERM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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-DERM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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