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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-three 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 / Packaging: see list16
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: Completed Condition: Psoriasis Vulgaris (Plaque Psoriasis)

Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects
Status: Completed 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: 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
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
SUSPENSION;TOPICAL022185-001May 9, 2008RXYes<disabled><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
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYes6,753,013<disabled>Y<disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYes5,763,426<disabled>YY<disabled>
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International Patent Family for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Country Document Number Publication Date
Hong Kong1077208Nov 28, 2008
European Patent Office2455083May 23, 2012
MexicoPA03003511May 04, 2004
Japan4426729Mar 03, 2010
China1115979Jan 31, 1996
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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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