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BETAMETHASONE DIPROPIONATE - Generic Drug Details

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What are the generic sources for betamethasone dipropionate and what is the scope of betamethasone dipropionate patent protection?

Betamethasone dipropionate is the generic ingredient in eleven branded drugs marketed by Fougera Pharms, Glenmark Generics, Perrigo New York, Taro, Tolmar, Schering, Merck Sharp Dohme, Savage Labs, Actavis Mid Atlantic, Pharmaderm, Teva, Teligent Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Hi-tech Pharmacal, Promius Pharma Llc, Leo Pharma As, Perrigo Israel, and Glenmark Pharms, and is included in sixty-three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has seven patent family members in five countries.

There are sixty-six drug master file entries for betamethasone dipropionate. Twenty suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE

International Patents:	7
US Patents:	9
Tradenames:	11
Applicants:	20
NDAs:	63
Drug Master File Entries:	66
Suppliers / Packagers:	20
Bulk Api Vendors:	34
Clinical Trials:	201
Patent Applications:	3,496
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE
DailyMed Link:	BETAMETHASONE DIPROPIONATE at DailyMed

Pharmacology for BETAMETHASONE DIPROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE

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	TACLONEX	betamethasone dipropionate; calcipotriene hydrate	SUSPENSION;TOPICAL	022185-001	May 9, 2008		RX	Yes	Yes			Y
Promius Pharma Llc	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Tolmar	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076603-001	Jan 23, 2004	AB	RX	No	No
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes

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Expired US Patents for BETAMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991
Merck Sharp Dohme	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986
Merck Sharp Dohme	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988

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International Patents for BETAMETHASONE DIPROPIONATE

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011026076
Japan	5833007
Japan	2013503203
European Patent Office	2473161