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Last Updated: July 6, 2020

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Calcifediol - Generic Drug Details

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

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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and twenty-eight patent family members in thirty-four countries.

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

Summary for calcifediol
Recent Clinical Trials for calcifediol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Junta de Andalucía - Consejería de Salud y FamiliasPhase 2
Dynamic SolutionsPhase 2
Maimónides Biomedical Research Institute of CórdobaPhase 2

See all calcifediol clinical trials

Pharmacology for calcifediol
Medical Subject Heading (MeSH) Categories for calcifediol

US Patents and Regulatory Information for calcifediol

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;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for calcifediol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Dow
McKesson
Colorcon
AstraZeneca

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 verification 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.