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Betamethasone dipropionate; calcipotriene hydrate - Generic Drug Details

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

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

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

Summary for Generic Name: betamethasone dipropionate; calcipotriene hydrate

Tradenames:2
Patents:2
Applicants:3
NDAs:4
Drug Master File Entries: see list65
Suppliers / Packaging: see list5
Formulation / Manufacturing:see details

Pharmacology for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Clinical Trials for: betamethasone dipropionate; calcipotriene hydrate

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
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYes6,753,013<disabled>Y <disabled>
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, 2006RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: betamethasone dipropionate; calcipotriene hydrate

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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, 2006RE39706<disabled>
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International Patent Family for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Country Document Number Estimated Expiration
Israel154888<disabled in preview>
World Intellectual Property Organization (WIPO)0064450<disabled in preview>
Bulgaria106030<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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