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Serving leading biopharmaceutical companies globally:

Julphar
Cerilliant
Farmers Insurance
Chinese Patent Office
US Army
Merck
Queensland Health
UBS
Citi
Healthtrust

Generated: February 25, 2018

DrugPatentWatch Database Preview

MONISTAT Drug Profile

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When do Monistat patents expire, and when can generic versions of Monistat launch?

Monistat is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms. and is included in twelve NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in MONISTAT is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

US Patents and Regulatory Information for MONISTAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Personal Prods MONISTAT 5 miconazole nitrate TAMPON;VAGINAL 018592-001 Oct 27, 1989 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Medtech Products MONISTAT 3 miconazole nitrate CREAM;VAGINAL 020827-001 Mar 30, 1998 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medtech Products MONISTAT 7 miconazole nitrate SUPPOSITORY;VAGINAL 018520-002 Feb 15, 1991 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for MONISTAT

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 ➤ Sign Up ➤ Sign Up
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MONISTAT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Vaginal Cream and Suppository 2% and 1.2 g ➤ Subscribe 12/5/2007

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Mallinckrodt
Daiichi Sankyo
Boehringer Ingelheim
Chinese Patent Office
Harvard Business School
McKesson
Covington
Julphar

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 verifification 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.

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