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Last Updated: July 26, 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 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.

Summary for miconazole
International Patents:24
US Patents:4
Tradenames:19
Applicants:16
NDAs:32
Drug Master File Entries: 28
Raw Ingredient (Bulk) Api Vendors: 96
Clinical Trials: 27
Patent Applications: 6,805
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
Aesculape CRO Belgium BVPhase 2
Hill Dermaceuticals, Inc.Phase 2/Phase 3
Abond CRO Inc.Phase 2/Phase 3

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
Medtech Products MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450-002 Feb 15, 1991 OTC Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
P And L MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 073507-001 Nov 19, 1993 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cosette MICONAZOLE 7 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 076585-001 Mar 26, 2004 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Perrigo MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074760-001 May 15, 1997 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
P And L M-ZOLE 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074926-001 Apr 16, 1999 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
Colorcon
Harvard Business School
Baxter

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