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Last Updated: May 8, 2021

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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 Eirgen and Organon Usa Inc, and is included in two NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and seventeen patent family members in thirty countries.

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

Summary for calcifediol
International Patents:117
US Patents:13
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 21
Patent Applications: 5,908
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in calcifediol?calcifediol excipients list
DailyMed Link:calcifediol at DailyMed
Recent Clinical Trials for calcifediol

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

SponsorPhase
Faes Farma, S.A.Phase 2/Phase 3
OPKO Health, Inc.Phase 2
FAES FarmaPhase 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
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016   Get Started for $10   Get Started for $10
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for calcifediol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 301085 Netherlands   Get Started for $10 PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Dow
McKesson
Colorcon
AstraZeneca

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