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 |
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
Sponsor | Phase |
---|---|
Shanghai Jiao Tong University School of Medicine | Phase 3 |
Indonesia University | Phase 2 |
Faes Farma, S.A. | Phase 2/Phase 3 |
Pharmacology for CALCIFEDIOL
Drug Class | Vitamin D3 Analog |
Medical Subject Heading (MeSH) Categories for CALCIFEDIOL
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|
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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CALCIFEDIOL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 10201703517V | STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME | ⤷ Sign Up |
European Patent Office | 3342405 | LIBÉRATION CONTRÔLÉE DE 25-HYDROXYVITAMINE D (CONTROLLED RELEASE 25-HYDROXYVITAMIN D) | ⤷ Sign Up |
Ecuador | SP23024864 | FORMULACIÓN DE VITAMINA D DE LIBERACIÓN MODIFICADA Y ESTABILIZADA Y MÉTODO DE ADMINISTRACIÓN DE LA MISMA | ⤷ Sign Up |
Serbia | 62176 | STABILIZOVANA FORMULACIJA VITAMINA D SA MODIFIKOVANIM OSLOBAĐANJEM I POSTUPAK ZA NJENU PRIMENU (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME) | ⤷ Sign Up |
Hungary | E052014 | ⤷ Sign Up | |
Japan | 2018012737 | 安定化調整放出ビタミンD製剤及びその投与方法 (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING THE 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 | 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 |
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 | 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 |
2968172 | 301095 | 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 | C02481400/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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