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Last Updated: October 10, 2024

Miconazole nitrate - Generic Drug Details


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What are the generic drug sources for miconazole nitrate and what is the scope of patent protection?

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for miconazole nitrate. Fifty-one suppliers are listed for this compound.

Summary for miconazole nitrate
Drug Prices for miconazole nitrate

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Drug Sales Revenue Trends for miconazole nitrate

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Recent Clinical Trials for miconazole nitrate

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

SponsorPhase
Aesculape CRO Belgium BVPhase 2
Population CouncilPhase 1
Biolab Sanus FarmaceuticaPhase 2

See all miconazole nitrate clinical trials

Pharmacology for miconazole nitrate
Drug ClassAzole Antifungal

US Patents and Regulatory Information for miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cosette MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 073507-001 Nov 19, 1993 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette M-ZOLE 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074926-001 Apr 16, 1999 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 074414-001 Apr 30, 1997 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 miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Sign Up ⤷  Sign Up
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

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