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Last Updated: July 26, 2021

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Betamethasone dipropionate; calcipotriene - Generic Drug Details

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

Betamethasone dipropionate; calcipotriene is the generic ingredient in five branded drugs marketed by Leo Pharma As, MC2, Perrigo Uk Finco, Tolmar, and Taro Pharms, and is included in nine 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; calcipotriene has fifty-five patent family members in twenty-nine countries.

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

Summary for betamethasone dipropionate; calcipotriene
International Patents:55
US Patents:9
Tradenames:5
Applicants:5
NDAs:9
Drug Master File Entries: 66
Finished Product Suppliers / Packagers: 7
Clinical Trials: 15
DailyMed Link:betamethasone dipropionate; calcipotriene at DailyMed
Recent Clinical Trials for betamethasone dipropionate; calcipotriene

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

SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Celgene CorporationPhase 4

See all betamethasone dipropionate; calcipotriene clinical trials

Pharmacology for betamethasone dipropionate; calcipotriene
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 NDA Submissiondate
ENSTILAR AEROSOL, FOAM;TOPICAL betamethasone dipropionate; calcipotriene 207589 2020-06-22
TACLONEX OINTMENT;TOPICAL betamethasone dipropionate; calcipotriene 021852 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 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Perrigo Uk Finco CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 212367-001 Sep 11, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>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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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Boehringer Ingelheim
Dow
McKesson
Harvard Business School

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