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Last Updated: April 18, 2024

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, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

See all miconazole clinical trials

Pharmacology for miconazole
Drug ClassAzole Antifungal

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
L Perrigo Co MICONAZOLE NITRATE COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 075329-001 Apr 20, 1999 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074136-001 Jan 4, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.