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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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Calcifediol has one hundred and forty-five 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: | 145 |
US Patents: | 14 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 98 |
Clinical Trials: | 20 |
Patent Applications: | 4,103 |
Formulation / Manufacturing: | see details |
DailyMed Link: | calcifediol at DailyMed |
Recent Clinical Trials for calcifediol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
OPKO Health, Inc. | Phase 2 |
Dynamic Solutions | Phase 2 |
Maimónides Biomedical Research Institute of Córdoba | Phase 2 |
Pharmacology for calcifediol
Drug Class | Vitamin 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 | Start Trial | Start Trial | Y | Start Trial | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Eirgen | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start 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 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 | Start Trial | Start Trial |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for calcifediol
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2007126470 | Start Trial |
Mexico | PA01013434 | Start Trial |
Cyprus | 1115567 | Start Trial |
Austria | 345113 | Start Trial |
South Korea | 20190141269 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for calcifediol
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2481400 | 301085 | Netherlands | Start 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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