➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Medtronic
Colorcon
AstraZeneca
Johnson and Johnson

Last Updated: August 4, 2021

DrugPatentWatch Database Preview

MICONAZOLE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic drug sources for miconazole and what is the scope of freedom to operate?

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
Abond CRO Inc.Phase 2/Phase 3
Hill Dermaceuticals, 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 SUPPOSITORY;VAGINAL 018520-002 Feb 15, 1991 OTC Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026-001 Feb 16, 2006 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074136-001 Jan 4, 1995 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cosette MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 074414-001 Apr 30, 1997 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Medtronic
Colorcon
AstraZeneca
Johnson and Johnson

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.