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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	37
Patent Applications:	7,798
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
Boston University	Phase 2/Phase 3
University of Alabama at Birmingham	Phase 4
Carilion Clinic	Early Phase 1

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
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Fougera Pharms	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078305-001	May 6, 2008	AT	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	CREAM;TOPICAL	020554-001	Jul 22, 1996	See Plans and Pricing	See Plans and Pricing
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	See Plans and Pricing	See Plans and Pricing
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	See Plans and Pricing	See Plans and Pricing
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	See Plans and Pricing	See Plans and Pricing
>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
Spain	2431330		See Plans and Pricing
New Zealand	508259	Mousse composition	See Plans and Pricing
Brazil	9913154	Composição de musse	See Plans and Pricing
Australia	2006253913	Vitamin formulation	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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