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Details for Generic Name: betamethasone dipropionate; calcipotriene hydrate

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Betamethasone dipropionate; calcipotriene hydrate is the generic ingredient in two branded drugs marketed by Perrigo Israel, Tolmar, and Leo Pharma As, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-one patent family members in thirty-four countries.

There are sixty-five drug master file entries for betamethasone dipropionate; calcipotriene hydrate. Four suppliers are listed for this compound.

Summary for Generic Name: betamethasone dipropionate; calcipotriene hydrate

Tradenames:2
Patents:4
Applicants:3
NDAs:4
Drug Master File Entries: see list65
Suppliers: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Clinical Trials for: betamethasone dipropionate; calcipotriene hydrate

The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris
Status: Completed Condition: Psoriasis Vulgaris

LEO 90105 Ointment in Japanese Subjects With Psoriasis
Status: Completed Condition: Psoriasis

A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
Status: Completed Condition: Psoriasis

LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
Status: Active, not recruiting Condition: Psoriasis Vulgaris (Plaque Psoriasis)

Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects
Status: Recruiting Condition: Skin and Connective Tissue Diseases

Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Status: Completed Condition: Scalp Psoriasis

Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Status: Not yet recruiting Condition: Psoriasis Vulgaris

Effect of LEO 90100 on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis VulgarisExtensive Psoriasis Vulgaris
Status: Completed Condition: Psoriasis Vulgaris

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
SUSPENSION;TOPICAL022185-001May 9, 2008RXYes<disabled><disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYesRE39706<disabled>YY<disabled>
Tolmar
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL201615-001Jan 14, 2013RXNo<disabled><disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
SUSPENSION;TOPICAL022185-001May 9, 2008RXYesRE39706<disabled>YY<disabled>
Perrigo Israel
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL200174-001Dec 12, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Country Document Number Publication Date
Finland952797Jun 07, 1995
New Zealand259679Nov 26, 1996
Japan2004512297Apr 22, 2004
Australia2001291637Apr 06, 2006
Cyprus1107294Nov 21, 2012
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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