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Last Updated: August 15, 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
Medtech Products MONISTAT 7 miconazole nitrate SUPPOSITORY;VAGINAL 018520-002 Feb 15, 1991 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro Pharms MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074444-001 Jan 13, 1997 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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
Mylan VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026-001 Feb 16, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes 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
France 2827517 SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE See Plans and Pricing
Japan 2004537558 See Plans and Pricing
European Patent Office 1408911 SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE (SUSTAINED-RELEASE THERAPEUTIC BIOADHESIVE SYSTEMS) See Plans and Pricing
China 101524337 See Plans and Pricing
Spain 2316108 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
Colorcon
Harvard Business School
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.