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Calcipotriene - Generic Drug Details

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What are the generic drug sources for calcipotriene and what is the scope of patent protection?

Calcipotriene is the generic ingredient in three branded drugs marketed by Mayne Pharma, Glenmark Pharms, Tolmar, Leo Pharma As, Glenmark Pharms Inc, Akorn, Cosette, Fougera Pharms, Novel Labs Inc, and Leo Pharm, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Calcipotriene has twenty-eight patent family members in thirteen countries.

There are twelve drug master file entries for calcipotriene. Fourteen suppliers are listed for this compound.

Summary for calcipotriene

International Patents:	28
US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	32
Patent Applications:	6,933
Drug Prices:	Drug price trends for calcipotriene
What excipients (inactive ingredients) are in calcipotriene?	calcipotriene excipients list
DailyMed Link:	calcipotriene at DailyMed

See drug prices for calcipotriene

Recent Clinical Trials for calcipotriene

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

Sponsor	Phase
Carilion Clinic	Early Phase 1
University of Alabama at Birmingham	Phase 4
Skin Sciences, PLLC	Phase 4

See all calcipotriene clinical trials

Pharmacology for calcipotriene

Drug Class

Vitamin D Analog

Paragraph IV (Patent) Challenges for CALCIPOTRIENE

Tradename	Dosage	Ingredient	NDA	Submissiondate
DOVONEX	CREAM;TOPICAL	calcipotriene	020554	2009-12-02
DOVONEX	SOLUTION;TOPICAL	calcipotriene	020611	2006-05-19

US Patents and Regulatory Information for calcipotriene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772-001	Jun 9, 2015	AB	RX	No	No
Tolmar	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	200935-001	May 30, 2012	AB	RX	No	No
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997		DISCN	Yes	No
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes			Y
Glenmark Pharms Inc	CALCIPOTRIENE	calcipotriene	OINTMENT;TOPICAL	090633-001	Mar 24, 2010		RX	No	Yes

Expired US Patents for calcipotriene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997

International Patents for calcipotriene

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006129161
Canada	2611147
European Patent Office	2526930
World Intellectual Property Organization (WIPO)	0015193
Austria	381315