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 nineteen patent family members in thirty-three countries.

There are two drug master file entries for calcifediol. One supplier is listed for this compound.

Summary for calcifediol

International Patents:	119
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	153
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
National Cancer Institute (NCI)	Phase 3
Alliance for Clinical Trials in Oncology	Phase 3
Boston University	Early Phase 1

See all calcifediol clinical trials

Pharmacology for calcifediol

Drug Class	Vitamin D3 Analog

Medical Subject Heading (MeSH) Categories for calcifediol

Bone Density Conservation Agents
Vitamins

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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				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	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

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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	018312-002	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
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

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Country	Patent Number	Estimated Expiration
Canada	2943032	Start Trial
Poland	1993559	Start Trial
Norway	332023	Start Trial
Lithuania	1993559	Start Trial
South Korea	101540369	Start Trial
>Country	>Patent Number	>Estimated Expiration

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