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Last Updated: March 28, 2024

Miconazole nitrate - Generic Drug Details


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What are the generic sources for miconazole nitrate and what is the scope of patent protection?

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by 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 NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for miconazole nitrate. Forty-seven suppliers are listed for this compound.

Drug Prices for miconazole nitrate

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Drug Sales Revenue Trends for miconazole nitrate

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Recent Clinical Trials for miconazole nitrate

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

SponsorPhase
Aesculape CRO Belgium BVPhase 2
Population CouncilPhase 1
Galeno Desenvolvimento de Pesquisas ClínicasPhase 2

See all miconazole nitrate clinical trials

Pharmacology for miconazole nitrate
Drug ClassAzole Antifungal

US Patents and Regulatory Information for miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Personal Prods MONISTAT 5 miconazole nitrate TAMPON;VAGINAL 018592-001 Oct 27, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 073507-001 Nov 19, 1993 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074030-001 Oct 30, 1992 DISCN 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
>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 nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 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.