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Serving leading biopharmaceutical companies globally:

Fuji
Julphar
Accenture
UBS
Merck
Mallinckrodt
Covington
Healthtrust
Baxter
Deloitte

Generated: October 23, 2017

DrugPatentWatch Database Preview

Calcifediol - Generic Drug Details

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What are the generic sources for calcifediol and what is the scope of calcifediol freedom to operate?

Calcifediol
is the generic ingredient in two branded drugs marketed by Opko Ireland Global and Organon Usa Inc, and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has eighty patent family members in twenty-five countries.

There are two drug master file entries for calcifediol. One supplier is listed for this compound.

Summary for Generic Name: calcifediol

US Patents:8
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list45
Clinical Trials: see list11
Patent Applications: see list2,287
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:calcifediol at DailyMed

Pharmacology for Ingredient: calcifediol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Opko Ireland Global
RAYALDEE
calcifediol
CAPSULE, EXTENDED RELEASE;ORAL208010-001Jun 17, 2016RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: calcifediol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Organon Usa Inc
CALDEROL
calcifediol
CAPSULE;ORAL018312-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: calcifediol

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
6,340,473 Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same► Subscribe
RE39079Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same► 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: calcifediol

Country Document Number Estimated Expiration
Canada2683997► Subscribe
Japan2007126470► Subscribe
MexicoPA01013434► Subscribe
Czech Republic20020037► Subscribe
Cyprus1118017► Subscribe
Australia735699► Subscribe
European Patent Office1993559► Subscribe
South Korea20170085141► Subscribe
World Intellectual Property Organization (WIPO)2008134512► Subscribe
Portugal2148661► 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:

Fuji
Dow
Farmers Insurance
Mallinckrodt
Express Scripts
US Department of Justice
Teva
Accenture
Moodys
Chubb

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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