CALCIPOTRIENE - Generic Drug Details

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

Calcipotriene is the generic ingredient in three branded drugs marketed by Mayne Pharma, Chartwell Rx, Glenmark Speclt, Leo Pharma As, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, 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-nine patent family members in thirteen countries.

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

Summary for CALCIPOTRIENE

International Patents:	29
US Patents:	2
Tradenames:	3
Applicants:	9
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	38
Patent Applications:	7,069
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
National Cancer Institute (NCI)	Phase 2
Boston University	Phase 2/Phase 3
University of Alabama at Birmingham	Phase 4

See all CALCIPOTRIENE clinical trials

Pharmacology for CALCIPOTRIENE

Drug Class	Vitamin D Analog

Paragraph IV (Patent) Challenges for CALCIPOTRIENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVONEX	Topical Cream	calcipotriene	0.005%	020554	1	2009-12-02
DOVONEX	Topical Solution	calcipotriene	0.005%	020611	1	2006-05-19

US Patents and Regulatory Information for CALCIPOTRIENE

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Glossary

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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
Cosette	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078468-001	Mar 24, 2011	AT	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078305-001	May 6, 2008	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772-001	Jun 9, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	077579-001	Nov 19, 2009		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

Expired US Patents for CALCIPOTRIENE

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

International Patents for CALCIPOTRIENE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006129161		⤷ Sign Up
Denmark	1112062		⤷ Sign Up
European Patent Office	1112062	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)	⤷ Sign Up
Canada	2333869	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	0015193		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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