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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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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.
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