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Serving leading biopharmaceutical companies globally:

Chubb
Chinese Patent Office
US Army
Dow
Novartis
UBS
US Department of Justice
Citi
Baxter
Queensland Health

Generated: December 12, 2017

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Calcipotriene - Generic Drug Details

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What are the generic drug sources for calcipotriene and what is the scope of calcipotriene patent protection?

Calcipotriene
is the generic ingredient in three branded drugs marketed by Mayne Pharma, Glenmark Pharms, Tolmar, Leo Pharma As, Glenmark Pharms Inc, Fougera Pharms, G And W Labs Inc, Hi Tech Pharma, and Leo Pharm, and is included in eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Calcipotriene has twenty-seven patent family members in twelve countries.

There are twelve drug master file entries for calcipotriene. Thirteen suppliers are listed for this compound.

Pharmacology for calcipotriene

Ingredient-typeVitamin D
Drug ClassVitamin D Analog
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Leo Pharma AsDOVONEXcalcipotrieneCREAM;TOPICAL020554-001Jul 22, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Fougera PharmsCALCIPOTRIENEcalcipotrieneSOLUTION;TOPICAL078305-001May 6, 2008ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mayne PharmaSORILUXcalcipotrieneAEROSOL, FOAM;TOPICAL022563-001Oct 6, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Leo PharmDOVONEXcalcipotrieneSOLUTION;TOPICAL020611-001Mar 3, 1997DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
TolmarCALCIPOTRIENEcalcipotrieneSOLUTION;TOPICAL077029-001Nov 20, 2009ATRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Mayne PharmaSORILUXcalcipotrieneAEROSOL, FOAM;TOPICAL022563-001Oct 6, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glenmark PharmsCALCIPOTRIENEcalcipotrieneCREAM;TOPICAL205772-001Jun 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Leo Pharma AsDOVONEXcalcipotrieneOINTMENT;TOPICAL020273-001Dec 29, 1993DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Glenmark Pharms IncCALCIPOTRIENEcalcipotrieneOINTMENT;TOPICAL090633-001Mar 24, 2010RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Hi Tech PharmaCALCIPOTRIENEcalcipotrieneSOLUTION;TOPICAL077579-001Nov 19, 2009ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: calcipotriene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo PharmDOVONEXcalcipotrieneSOLUTION;TOPICAL020611-001Mar 3, 1997► Subscribe► Subscribe
Leo Pharma AsDOVONEXcalcipotrieneCREAM;TOPICAL020554-001Jul 22, 1996► Subscribe► Subscribe
Leo PharmDOVONEXcalcipotrieneSOLUTION;TOPICAL020611-001Mar 3, 1997► Subscribe► Subscribe
Leo Pharma AsDOVONEXcalcipotrieneOINTMENT;TOPICAL020273-001Dec 29, 1993► Subscribe► Subscribe
Leo PharmDOVONEXcalcipotrieneSOLUTION;TOPICAL020611-001Mar 3, 1997► Subscribe► Subscribe
Leo Pharma AsDOVONEXcalcipotrieneCREAM;TOPICAL020554-001Jul 22, 1996► Subscribe► Subscribe
Leo Pharma AsDOVONEXcalcipotrieneCREAM;TOPICAL020554-001Jul 22, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: calcipotriene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,730,288 Mousse composition► Subscribe
8,298,515Vitamin formulation► Subscribe
7,029,659Mousse composition► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: calcipotriene

Country Document Number Estimated Expiration
AustraliaPP583198► Subscribe
New Zealand508259► Subscribe
Australia2006253913► Subscribe
Spain2431330► Subscribe
Spain2407407► Subscribe
Spain2447301► Subscribe
Japan4603164► Subscribe
Germany69937802► Subscribe
Japan5612263► Subscribe
European Patent Office2526930► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
Harvard Business School
Chinese Patent Office
Moodys
Dow
Daiichi Sankyo
QuintilesIMS
Fish and Richardson
Johnson and Johnson

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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