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.
Summary for CALDEROL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Patent Applications: | 3,423 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CALDEROL at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | 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 CALDEROL
| 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 |
| 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 |
| 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 CALDEROL
See the table below for patents covering CALDEROL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | S5037665 | ⤷ Try a Trial | |
| United Kingdom | 1261292 | ⤷ Try a Trial | |
| Denmark | 135582 | ⤷ Try a Trial | |
| Netherlands | 7003686 | ⤷ Try a Trial | |
| Canada | 992067 | ⤷ Try a Trial | |
| France | 2035000 | ⤷ Try a Trial | |
| Canada | 970362 | PROCESS FOR PREPARING 25-HYDROXYCHOLECALCIFEROL | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CALDEROL
| 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 | CA 2021 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818 |
| 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 |
| 2481400 | CA 2020 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: UK PL 50784/0005-0001 20200721 |
| 2481400 | C02481400/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020 |
| 2968172 | 122021000009 | Germany | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818 |
| 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 |
| >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.
ISSN: 2162-2639
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