Betamethasone dipropionate; calcipotriene - Generic Drug Details

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

Betamethasone dipropionate; calcipotriene is the generic ingredient in five branded drugs marketed by Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Padagis Israel, Cosette, and Taro, and is included in ten NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate; calcipotriene has eighty-four patent family members in thirty-two countries.

Eight suppliers are listed for this compound.

Summary for betamethasone dipropionate; calcipotriene

International Patents:	84
US Patents:	10
Tradenames:	5
Applicants:	7
NDAs:	10
Finished Product Suppliers / Packagers:	8
Clinical Trials:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for betamethasone dipropionate; calcipotriene
DailyMed Link:	betamethasone dipropionate; calcipotriene at DailyMed

Recent Clinical Trials for betamethasone dipropionate; calcipotriene

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 4
Eli Lilly and Company	Phase 4
Celgene Corporation	Phase 4

See all betamethasone dipropionate; calcipotriene clinical trials

Pharmacology for betamethasone dipropionate; calcipotriene

Drug Class	Corticosteroid Vitamin D Analog
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENSTILAR	Topical Foam	betamethasone dipropionate; calcipotriene	0.005%/0.064%	207589	1	2020-06-22
TACLONEX	Ointment	betamethasone dipropionate; calcipotriene	0.005%/0.064%	021852	1	2010-03-31

US Patents and Regulatory Information for betamethasone dipropionate; calcipotriene

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	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes					Y
Glenmark Pharms Ltd	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	214688-001	Mar 21, 2023	AB	RX	No	No
Cosette	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	210765-001	May 11, 2020	AB	RX	No	No
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes			Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes					Y
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422-001	Jul 20, 2020		RX	Yes	Yes			Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes			Y

Expired US Patents for betamethasone dipropionate; calcipotriene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008

International Patents for betamethasone dipropionate; calcipotriene

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115991
World Intellectual Property Organization (WIPO)	2011154004
Mexico	2020009764	COMPOSICION TOPICA. (TOPICAL COMPOSITION.)
Spain	2896931
Poland	3768241
Argentina	065740	COMPOSICION TOPICA DE POLIAPHONES CON VITAMINA D Y CORTICOIDE.
China	101674808	Polyaphron topical composition with vitamin d and corticosteroid