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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-six 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 list66
Suppliers / Packaging: see list5
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: 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
SUSPENSION;TOPICAL022185-001May 9, 2008RXYes► subscribe► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
SUSPENSION;TOPICAL022185-001May 9, 2008RXYes6,787,529► subscribeY ► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RXYes6,753,013► subscribeY ► subscribe
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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
SUSPENSION;TOPICAL022185-001May 9, 2008RE39706► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RE39706► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 20064,866,048► subscribe
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International Patent Family for Ingredient: betamethasone dipropionate; calcipotriene hydrate

Country Document Number Estimated Expiration
Slovakia287653► subscribe
Japan2013075923► subscribe
Japan2015155451► subscribe
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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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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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