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Last Updated: March 3, 2021

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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, P And L, Actavis Mid Atlantic, Cosette, Perrigo R And D, Perrigo, Medtech Products, Insight Pharms, Taro, Taro Pharms, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There are five 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.

Summary for miconazole
International Patents:24
US Patents:5
Tradenames:19
Applicants:16
NDAs:32
Drug Master File Entries: 28
Bulk Api Vendors: 93
Clinical Trials: 26
Patent Applications: 4,535
Formulation / Manufacturing:see details
Drug Prices: Drug price trends for miconazole
What excipients (inactive ingredients) are in miconazole?miconazole excipients list
DailyMed Link:miconazole at DailyMed
Drug Prices for miconazole

See drug prices for miconazole

Drug Sales Revenue Trends for miconazole

See drug sales revenues for miconazole

Recent Clinical Trials for miconazole

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

SponsorPhase
Abond CRO Inc.Phase 2/Phase 3
Hill Dermaceuticals, Inc.Phase 2/Phase 3
William N HandelmanPhase 2

See all miconazole clinical trials

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
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 091366-001 Jan 15, 2010 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074760-001 May 15, 1997 OTC No No   Start Trial   Start Trial   Start Trial
Mylan VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026-001 Feb 16, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Perrigo MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 074395-001 Mar 20, 1997 OTC No Yes   Start Trial   Start Trial   Start Trial
Taro MICONAZOLE 3 miconazole nitrate CREAM;VAGINAL 076773-001 Mar 2, 2005 OTC No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Merck
Medtronic
Baxter
Express Scripts

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