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Last Updated: May 26, 2022

Miconazole - Generic Drug Details


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

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

Miconazole has twenty-four patent family members in fourteen countries.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Summary for miconazole
Drug Prices for miconazole

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Drug Sales Revenue Trends for miconazole

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Recent Clinical Trials for miconazole

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

SponsorPhase
Aesculape CRO Belgium BVPhase 2
Hill Dermaceuticals, Inc.Phase 2/Phase 3
Abond CRO Inc.Phase 2/Phase 3

See all miconazole clinical trials

Pharmacology for miconazole

US Patents and Regulatory Information for miconazole

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 LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L MICONAZOLE 7 miconazole nitrate CREAM;VAGINAL 074164-001 Mar 29, 1996 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450-002 Feb 15, 1991 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 091366-001 Jan 15, 2010 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for miconazole

Country Patent Number Title Estimated Expiration
Japan 2004537558 See Plans and Pricing
Spain 2316108 See Plans and Pricing
European Patent Office 1792610 Systèmes thérapeutiques bioadhésifs à libération prolongée (Sustained release bioadhesive therapeutic systems) See Plans and Pricing
World Intellectual Property Organization (WIPO) 03009800 See Plans and Pricing
France 2827517 SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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