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Serving leading biopharmaceutical companies globally:

Chubb
Mallinckrodt
Teva
Harvard Business School
Baxter
Fish and Richardson
UBS
McKesson
Citi
Moodys

Generated: November 20, 2017

DrugPatentWatch Database Preview

RAYALDEE Drug Profile

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What is the patent landscape for Rayaldee, and when can generic versions of Rayaldee launch?

Rayaldee is a drug marketed by Opko Ireland Global and is included in one NDA. There are eight patents protecting this drug.

This drug has eighty patent family members in twenty-five countries.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

Pharmacology for RAYALDEE

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Medical Subject Heading (MeSH) Categories for RAYALDEE

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► 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► SubscribeY ► 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► 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
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Non-Orange Book Patents for Tradename: RAYALDEE

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 Tradename: RAYALDEE

Country Document Number Estimated Expiration
Japan3947003► Subscribe
MexicoPA01013434► Subscribe
Japan5869745► Subscribe
South Korea101691876► Subscribe
Canada2375652► Subscribe
Hong Kong1200732► Subscribe
Japan2007126470► Subscribe
Japan2014065751► Subscribe
Japan2014031387► Subscribe
Cyprus1118017► 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:

Daiichi Sankyo
Queensland Health
McKesson
Argus Health
Fuji
Fish and Richardson
Novartis
Accenture
Cerilliant
Healthtrust

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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