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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-eight 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

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: Completed 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;TOPICAL022185-002Oct 29, 2015RXYes6,753,013<disabled>Y <disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
SUSPENSION;TOPICAL022185-001May 9, 2008RXYesRE39706<disabled>YY <disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: betamethasone dipropionate; calcipotriene hydrate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 20064,866,048<disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
SUSPENSION;TOPICAL022185-001May 9, 2008RE39706<disabled>
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 20065,763,426<disabled>
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International Patent Family for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Country Document Number Publication Date
European Patent Office1331927Aug 06, 2003
Portugal1178808Aug 16, 2012
Poland360941Sep 20, 2004
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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