BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - Generic Drug Details

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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

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

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

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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
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422-001	Jul 20, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Padagis Israel	CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	212367-001	Sep 11, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Taro	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	213269-001	Sep 2, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	200174-001	Dec 12, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

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

International Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

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Country	Patent Number	Title	Estimated Expiration
Mexico	2020009764	COMPOSICION TOPICA. (TOPICAL COMPOSITION.)	⤷ Sign Up
Philippines	12020551467	TOPICAL COMPOSITION	⤷ Sign Up
European Patent Office	2579852	COMPOSITION PHARMACEUTIQUE PULVERISABLE COMPRENANT UN VITAMINE D ANALOGUE ET UN COTICOSTEROID (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)	⤷ Sign Up
Canada	2680405	COMPOSITION TOPIQUE DE POLYAPHRON AVEC VITAMINE D ET CORTICOSTEROIDE (POLYAPHRON TOPICAL COMPOSITION WITH VITAMIN D AND CORTICOSTEROID)	⤷ Sign Up
Slovenia	2579852		⤷ Sign Up
Canada	2800181		⤷ Sign Up
European Patent Office	2859886		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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