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Last Updated: December 12, 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-two 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:172
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
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CALCIFEDIOL

Country Patent Number Title Estimated Expiration
Hungary E056937 ⤷  Sign Up
Japan 2017075183 慢性腎臓病における続発性副甲状腺機能亢進症の安全かつ効果的な治療および予防方法 (METHOD OF SAFELY AND EFFECTIVELY TREATING AND PREVENTING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE) ⤷  Sign Up
Poland 2481400 ⤷  Sign Up
Denmark 3342405 ⤷  Sign Up
Eurasian Patent Organization 038867 СТАБИЛИЗИРОВАННЫЙ СОСТАВ ВИТАМИНА D С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION) ⤷  Sign Up
Hong Kong 1220128 穩定化修飾釋放維生素 製劑和施用其的方法 (STABILIZED MODIFIED RELEASE VITAMIN FORMULATION AND METHOD OF ADMINISTRING SAME) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALCIFEDIOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 C02481400/01 Switzerland ⤷  Sign Up PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020
2481400 122020000079 Germany ⤷  Sign Up 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
2481400 CA 2020 00059 Denmark ⤷  Sign Up PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721
2968172 122021000009 Germany ⤷  Sign Up PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2481400 132021000000071 Italy ⤷  Sign Up PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400 C202130022 Spain ⤷  Sign Up 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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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.