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Last Updated: July 16, 2024

CALDEROL Drug Patent Profile


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When do Calderol patents expire, and what generic alternatives are available?

Calderol is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in CALDEROL 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.

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Drug patent expirations by year for CALDEROL

US Patents and Regulatory Information for CALDEROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  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 CALDEROL

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 ⤷  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 018312-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CALDEROL

See the table below for patents covering CALDEROL around the world.

Country Patent Number Title Estimated Expiration
Canada 931075 25-HYDROXYCHOLECALCIFEROL ⤷  Sign Up
France 2035000 ⤷  Sign Up
United Kingdom 1261292 ⤷  Sign Up
Switzerland 510657 Verfahren zur Herstellung von C25-hydroxyliertem Vitamin D2 und Vitamin D3 (25-hydroxy ergocalciferol and 25-hydroxy-) ⤷  Sign Up
Canada 992067 ⤷  Sign Up
Netherlands 7003686 ⤷  Sign Up
Israel 33512 A PROCESS FOR PREPARING 25-HYDROXYCHOLECALCIFEROL ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALDEROL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2968172 SPC/GB20/043 United Kingdom ⤷  Sign Up PRODUCT NAME: CALCIFEDIOL, AND/OR A SALT OR HYDRATE THEREOF, IN PARTICULAR CALCIFEDIOL MONOHYDRATE; REGISTERED: UK PL 50784/0005-0001 20200721
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
2481400 301085 Netherlands ⤷  Sign Up 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 ⤷  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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