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
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 018312-001 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | ⤷ Subscribe | ⤷ Subscribe |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-001 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CALCIFEDIOL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2683997 | 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) | ⤷ Subscribe |
Spain | 2904546 | ⤷ Subscribe | |
Japan | 2010525078 | ⤷ Subscribe | |
Slovenia | 2148661 | ⤷ Subscribe | |
Philippines | 12015502162 | STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME | ⤷ Subscribe |
South Korea | 20190095216 | 안정화되고 변형된 비타민 D 방출 제형 및 이의 투여 방법 (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CALCIFEDIOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2968172 | CA 2021 00005 | Denmark | ⤷ Subscribe | PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818 |
2481400 | 122020000079 | Germany | ⤷ Subscribe | 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 | 301085 | Netherlands | ⤷ Subscribe | 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 | ⤷ Subscribe | PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020 |
2481400 | 132021000000071 | Italy | ⤷ Subscribe | PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721 |
2968172 | 301095 | Netherlands | ⤷ Subscribe | 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 |
CALCIFEDIOL Market Analysis and Financial Projection Experimental
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