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Last Updated: February 23, 2024

Calcifediol - Generic Drug Details


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What are the generic 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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and seventy-one patent family members in thirty-six countries.

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

Summary for calcifediol
International Patents:171
US Patents:16
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 201
Clinical Trials: 23
Patent Applications: 5,620
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in calcifediol?calcifediol excipients list
DailyMed Link:calcifediol at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for calcifediol
Generic Entry Date for calcifediol*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for calcifediol

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 3
Indonesia UniversityPhase 2
Faes Farma, S.A.Phase 2/Phase 3

See all calcifediol clinical trials

Pharmacology for calcifediol
Drug ClassVitamin D3 Analog
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 018312-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for calcifediol

Country Patent Number Title Estimated Expiration
Slovenia 3095447 ⤷  Try a Trial
Canada 2943032 COMPOSITIONS ORALES A LIBERATION CONTROLEE COMPRENANT DES COMPOSES DE VITAMINE D ET UN VEHICULE CIREUX (ORAL CONTROLLED RELEASE COMPOSITIONS COMPRISING VITAMIN D COMPOUND AND WAXY CARRIER) ⤷  Try a Trial
European Patent Office 3332773 FORMULATION DE VITAMINE D À LIBÉRATION MODIFIÉE STABILISÉE ET SON PROCÉDÉ D'ADMINISTRATION (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME) ⤷  Try a Trial
South Korea 20100028536 비타민 D 화합물과 밀랍성 담체를 포함하는 경구 조절성 방출 조성물 (ORAL CONTROLLED RELEASE COMPOSITIONS COMPRISING VITAMIN D COMPOUND AND WAXY CARRIER) ⤷  Try a Trial
Portugal 3332773 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for calcifediol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 122020000079 Germany ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721
2968172 301095 Netherlands ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172 132021000000074 Italy ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400 301085 Netherlands ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2481400 C202130022 Spain ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL; NATIONAL AUTHORISATION NUMBER: 85519-DE/H/5590/001/DC; DATE OF AUTHORISATION: 20201230; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE/H/5590/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20200721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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