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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 freedom to operate?
Calcifediol
is the generic ingredient in two branded drugs marketed by Opko Ireland Global 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 twenty-five patent family members in thirty-four countries.
There are two drug master file entries for calcifediol. One supplier is listed for this compound.
Summary for calcifediol
| International Patents: | 125 |
| US Patents: | 14 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 155 |
| Clinical Trials: | 18 |
| Patent Applications: | 2,622 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | calcifediol at DailyMed |
Recent Clinical Trials for calcifediol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alliance for Clinical Trials in Oncology | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
| Boston University | Early Phase 1 |
Pharmacology for calcifediol
| Drug Class | Vitamin D3 Analog |
Medical Subject Heading (MeSH) Categories for calcifediol
Synonyms for calcifediol
| (?R,1R,3aS,4E,7aR)-4-[(2Z)-2-[(5S)-5-hydroxy-2-methylenecyclohexylidene]ethylidene]octahydro-?,?,?,7a-tetramethyl-1H-indene-1-pentanol |
| (|AR,1R,3aS,4E,7aR)-Octahydro-4-[(2Z)-2-[(5R)-5-hydroxy-2-methylenecyclohexylidene]ethylidene]-|A,|A,|A,7a-tetramethyl-H-indene-1-pentanol |
| (1R,3Z)-3-[(2E)-2-[(1R,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (1S,3E)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(1R)-5-hydroxy-1,5-dimethyl-hexyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-cyclohexanol |
| (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (1S,3Z)-3-[(2E)-2-[(1R,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (1S)-3-[2-[(1R,3aS,7aR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (3|A,5Z,7E)-9,10-Seco-cholesta-5,7,10(19)-triene-3,25-diol |
| (3|A,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-3,25-diol |
| (3b,5Z,7E)- 9,10-Secocholesta-5,7,10(19)-triene-3,25-diol |
| (3beta,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol |
| (3E)-3-[(2E)-2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| (3S,5Z,14beta,17alpha)-9,10-secocholesta-5,7,10-triene-3,25-diol |
| (3S,5Z,7E)-9,10-seco-5,7,10(19)-cholestatriene-3,25-diol |
| (3S,5Z,7E)-9,10-secocholesta-5,7,10-triene-3,25-diol |
| (3S,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol |
| (5E,7E)-9,10-Secocholesta-5,7,10(19)-triene-3beta,25-diol |
| (5E,7Z)-(3S)-9,10-seco-5,7,10(19)-cholestatriene-3,25-diol |
| (5Z,7E)-(3R)-9,10-seco-5,7,10(19)-cholestatriene-3,25-diol |
| (5Z,7E)-(3S)-9,10-seco-5,7,10(19)-cholestatriene-3,25-diol |
| (5Z,7E)-(3S)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol |
| (5Z,7E)-9,10-Seco-5,7,10(19)-cholestatrien-3beta,25-diol |
| (5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-3.beta.,25-diol # |
| (R,Z)-3-(2-((1R,3aS,7aR,E)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexan-1-ol |
| (S,E)-3-((E)-2-((1R,3aS,7aR)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methylhexahydro-1H-inden-4(2H)-ylidene)ethylidene)-4-methylenecyclohexanol |
| (S,Z)-3-((E)-2-((1R,3aS,7aR)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-methylenecyclohexanol |
| (S,Z)-3-((E)-2-((1R,3aS,7aR)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methylhexahydro-1H-inden-4(2H)-ylidene)ethylidene)-4-methylenecyclohexanol |
| (S,Z)-3-(2-((1R,3aS,7aR,E)-1-((R)-6-hydroxy-6-methylheptan-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)-4-methylenecyclohexan-1-ol |
| 1233749-00-2 |
| 1384584-62-6 |
| 19356-17-3 |
| 25-(OH)Vitamin D3 |
| 25-HCC |
| 25-Hydroxy D3 |
| 25-Hydroxy vitamin D |
| 25-Hydroxy vitamin D3 |
| 25-Hydroxy-3-epivitamin D3 |
| 25-hydroxy-cholecalciferol |
| 25-Hydroxycholecalciferol |
| 25-Hydroxycholecalciferol monohydrate |
| 25-Hydroxycholecalciferol solution |
| 25-Hydroxycholecalciferol, >=98% (HPLC) |
| 25-Hydroxycholecalciferol, 5-trans- |
| 25-Hydroxycholescalciferol |
| 25-Hydroxyvitamin D |
| 25-hydroxyvitamin D3 |
| 25-hydroxyvitamin D3 / 25-hydroxycholecalciferol / calcidiol |
| 25-Hydroxyvitamin D3 monohydrate |
| 25-Hydroxyvitamin D3 monohydrate, >=99.0% (HPLC) |
| 25-Hydroxyvitamin D3 solution |
| 25-Hydroxyvitamin D3 solution, 100 mug/mL in ethanol, 98% (CP) |
| 25-Hydroxyvitamin D3 solution, 100 mug/mL in ethanol, ampule of 1 mL, certified reference material |
| 25-Hydroxyvitamin D3 solution, 5 mug/mL in ethanol, 98% (CP) |
| 25-Hydroxyvitamin D3 solution, 5 mug/mL in ethanol, ampule of 1 mL, certified reference material |
| 25-Hydroxyvitamin D3 solution, 50 mug/mL in ethanol, 98% (CP) |
| 25(OH)D3 |
| 25631-40-7 |
| 3-[2-[1-(5-hydroxy-1,5-dimethyl-hexyl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-cyclohexanol |
| 3-[2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol |
| 3-{2-[1-(5-HYDROXY-1,5-DIMETHYL-HEXYL)-7A-METHYL-OCTAHYDRO-INDEN-4-YLIDENE]-ETHYLIDENE}-4-METHYLENE-CYCLOHEXANOL |
| 3-epi-25-Hydroxy Vitamin D3 |
| 3-Epi-25-Hydroxyvitamin D3 |
| 3-epi-25-Hydroxyvitamin D3 solution, 100 mug/mL in ethanol, 98% (CP) |
| 3-epi-25-Hydroxyvitamin D3 solution, 50 mug/mL in ethanol, 98% (CP) |
| 3-epi-25-Hydroxyvitamin D3 solution, 50 mug/mL in ethanol, certified reference material |
| 3-epi-25-Hydroxyvitamin D3, 98% (CP) |
| 356C173 |
| 36149-00-5 |
| 5,6-cis-25-Hydroxy Vitamin D3 |
| 5,6-cis-25-Hydroxyvitamin D3 |
| 5,6-trans-25-Hydroxy vitamin D3 |
| 5,6-trans-25-Hydroxycholescalciferol |
| 5,6-trans-25-Hydroxyvitamin D3 |
| 5,6-trans-9,10-Seco-5,7,10(19)-cholestatrien-3beta,25-diol |
| 63283-36-3 |
| 64719-49-9 |
| 73809-05-9 |
| 78782-98-6 |
| 9,10-Secocholesta-5,7,10(19)-triene-1,25-diol, (3.beta,.5Z,7E)- |
| 9,10-Secocholesta-5,7,10(19)-triene-3,25-diol, (3.beta.,5Z,7E)- |
| 9,10-Secocholesta-5,7,10(19)-triene-3,25-diol, (3beta,5E,7E)- |
| 9,10-Secocholesta-5,7,10(19)-triene-3,25-diol, (3beta,5Z,7E)- |
| 9,10-Secocholesta-5,7,10(19)-triene-3.beta.,25-diol |
| 9,10-Secocholesta-5,7,10(19)-triene-3b,25-diol |
| 9,10-Secocholesta-5,7,10(19)-triene-3beta,25-diol |
| AB01275461_02 |
| AB01275461-01 |
| AB2000120 |
| AC1L1BT0 |
| AC1L4YCK |
| AC1NQX1D |
| AC1NR2WF |
| AC1NS422 |
| AC1O5GOQ |
| AC1O6T7Q |
| ACT06833 |
| AJ-62415 |
| AK115143 |
| AKOS005146518 |
| AKOS015840003 |
| AKOS015960730 |
| AKOS015965097 |
| AKOS016010097 |
| AKOS032945268 |
| AKOS032960352 |
| AN-015 |
| B91135EC-8937-4D8B-A533-CCD82F33C1B0 |
| BC219279 |
| BCP01929 |
| BCP9000472 |
| BCPP000306 |
| Bio1_000100 |
| Bio1_000589 |
| Bio1_001078 |
| Bio2_000131 |
| Bio2_000611 |
| BML2-E02 |
| BRD-A78971512-001-01-5 |
| BRD-K77175907-001-01-5 |
| BSPBio_001411 |
| C01561 |
| Calcidiol |
| Calcidiol;Didrogyl;Hidroferol |
| Calcifediol [INN] |
| Calcifediol anhydrous |
| Calcifediol, European Pharmacopoeia (EP) Reference Standard |
| Calcifediol, United States Pharmacopeia (USP) Reference Standard |
| Calcifediolum |
| Calcifediolum [INN-Latin] |
| Calcifidiol |
| Calderol |
| Calderol (TN) |
| CAS-19356-17-3 |
| CBiol_001814 |
| CHEBI:125445 |
| CHEBI:17933 |
| CHEBI:94743 |
| CHEMBL1040 |
| CHEMBL3250186 |
| Cholecalciferol, 25-hydroxy- |
| CS-0800 |
| CS-M3650 |
| CTK8E9743 |
| CTK8F5046 |
| DB00146 |
| Dedrogyl |
| Delakmin |
| Didrogyl |
| DM100 |
| DSSTox_CID_2721 |
| DSSTox_GSID_22721 |
| DSSTox_RID_76699 |
| DTXSID0022721 |
| DTXSID30274318 |
| EINECS 242-990-9 |
| FT-0082670 |
| FT-0604695 |
| FT-0650575 |
| FT-0670229 |
| GTPL6921 |
| Hidroferol |
| HMS1361G13 |
| HMS1791G13 |
| HMS1989G13 |
| HMS2089L21 |
| HMS3402G13 |
| HY-32351 |
| Hy-D |
| IDI1_033881 |
| JWUBBDSIWDLEOM-DTOXIADCSA-N |
| JWUBBDSIWDLEOM-XHQRYOPUSA-N |
| KBio2_000131 |
| KBio2_002699 |
| KBio2_005267 |
| KBio3_000261 |
| KBio3_000262 |
| KBioGR_000131 |
| KBioSS_000131 |
| KS-00000XN4 |
| LMST03020246 |
| LMST03020646 |
| LMST03020655 |
| LS-187713 |
| MFCD00867077 |
| MolPort-003-927-271 |
| MolPort-027-835-871 |
| NCGC00161326-01 |
| NCGC00161326-04 |
| NCGC00179206-01 |
| PubChem18824 |
| Rayaldee |
| Ro 8-8892 |
| Rovimix Hy-D |
| Ryaldee |
| s1469 |
| SC-76996 |
| SCHEMBL10018928 |
| SCHEMBL15263247 |
| SCHEMBL16136766 |
| SCHEMBL1836573 |
| SCHEMBL2734120 |
| SCHEMBL3296 |
| SCHEMBL3333455 |
| SCHEMBL7901515 |
| SN331791VY |
| Spectrum5_001931 |
| SR-05000001468 |
| SR-05000001468-1 |
| ST2407990 |
| SW219602-1 |
| T0WXW8F54E |
| Tox21_111987 |
| U-32070E |
| UNII-SN331791VY |
| UNII-T0WXW8F54E |
| VDY |
| Vitamin D, 25-hydroxy- |
| Vitamin D3 25-hydroxy monohydrate |
| W-201718 |
| W-5159 |
| ZINC12484926 |
| ZINC13525982 |
| ZINC4474414 |
| ZX-AFC002925 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon Usa Inc | CALDEROL | calcifediol | CAPSULE;ORAL | 018312-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Opko Ireland Global | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Opko Ireland Global | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Opko Ireland Global | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Opko Ireland Global | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Opko Ireland Global | RAYALDEE | calcifediol | CAPSULE, EXTENDED RELEASE;ORAL | 208010-001 | Jun 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
|---|---|---|---|---|---|---|---|
| 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 | 018312-001 | 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 | 018312-002 | 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 |
|---|---|---|
| Czech Republic | 300190 | Start Trial |
| Japan | 4763590 | Start Trial |
| European Patent Office | 2968172 | Start Trial |
| South Korea | 20140131603 | Start Trial |
| Japan | 2019135264 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2008134512 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.