MYCELEX Drug Patent Profile

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Mycelex is a drug marketed by Bayer Healthcare Llc, Bayer Hlthcare, and Bayer Pharms. and is included in seven NDAs.

The generic ingredient in MYCELEX is clotrimazole. There are eleven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

A generic version of MYCELEX was approved as clotrimazole by P AND L on July 16^th, 1993.

US Patents:	0
Applicants:	3
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	3
Patent Applications:	4,029
Formulation / Manufacturing:	see details
DailyMed Link:	MYCELEX at DailyMed

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 4
Onxeo	Phase 3
Boehringer Ingelheim	Phase 3

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	CREAM;VAGINAL	018230-002	Dec 26, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare Llc	MYCELEX-7 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020389-002	Jun 23, 1994		DISCN	No	No	⤷ 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983	⤷ Sign Up	⤷ Sign Up
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering MYCELEX around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	285600		⤷ Sign Up
Ireland	32348	N-TRITYL-IMIDAZOLES AND SALTS AND USES THEREOF	⤷ Sign Up
Yugoslavia	34085		⤷ Sign Up
Switzerland	571503		⤷ Sign Up
Sweden	370074		⤷ Sign Up
Canada	946391	N-TRITYL-IMIDAZOLES AND THEIR PRODUCTION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration