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Generated: July 17, 2018

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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 calcifediol 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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcifediol has one hundred and three 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
Pharmacology for calcifediol
Ingredient-typeCholecalciferol
Drug ClassVitamin 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
(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,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-[(1R)-5-hydroxy-1,5-dimethyl-hexyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-cyclohexanol hydrate
(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,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 hydrate
(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;hydrate
(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
(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
(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
(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
(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 hydrate
1384584-62-6
19356-17-3
2298AH
25-(OH)Vitamin D3
25-hydroxy-cholecalciferol
25-Hydroxycholecalciferol
25-Hydroxycholecalciferol (Calcifediol)
25-Hydroxycholecalciferol monohydrate
25-Hydroxycholecalciferol, >=98% (HPLC)
25-Hydroxycholescalciferol
25-Hydroxyvitamin D
25-hydroxyvitamin D3
25-hydroxyvitamin D3 / 25-hydroxycholecalciferol / calcidiol
25-HYDROXYVITAMIN D3 HYDRATE
25-Hydroxyvitamin D3 monohydrate
25-Hydroxyvitamin D3 monohydrate, >=99.0% (HPLC)
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-VD3
25(OH)D3
25631-40-7
3-{2-[1-(5-HYDROXY-1,5-DIMETHYL-HEXYL)-7A-METHYL-OCTAHYDRO-INDEN-4-YLIDENE]-ETHYLIDENE}-4-METHYLENE-CYCLOHEXANOL
356C173
36149-00-5
4-?[(2Z)-?2-?[(5S)-?5-?HYDROXY-?2-?METHYLENECYCLOHEXYLIDENE]ETHYLIDENE]OCTAHYDRO-?ALPHA,?ALPHA,?EPSILON,?7A-?TETRAMETHYL-?(EPSILONR,?1R,?3AS,?4E,?7AR)-?1H-?INDENE-?1-?PENTANOL
5,6-cis-25-Hydroxyvitamin D3
5,6-trans-25-Hydroxycholescalciferol
5,6-trans-9,10-Seco-5,7,10(19)-cholestatrien-3beta,25-diol
63283-36-3
64719-49-9
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 monohydrate, (3beta,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, monohydrate, (3beta,5Z,7E)-
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
ABP000386
AC1NR2WF
AC1O5V7N
ACT06833
AKOS015965097
AKOS025312293
AN-16064
B91135EC-8937-4D8B-A533-CCD82F33C1B0
BC204154
BC219279
BCP9000472
BCPP000306
BML2-E02
BRD-K77175907-001-01-5
BSPBio_001411
C01561
C27H44O2.H2O
Calcidiol
Calcidiol;Didrogyl;Hidroferol
Calcifediol (monohydrate)
Calcifediol (USP/INN)
Calcifediol [INN]
Calcifediol [USAN:USP:INN:BAN]
Calcifediol anhydrous
Calcifediol hydrate
Calcifediol monohydrate
Calcifediol, European Pharmacopoeia (EP) Reference Standard
Calcifediol, United States Pharmacopeia (USP) Reference Standard
Calcifediol/calcidiol, 25-hydroxycholecalcifer,Didrogyl,Hidroferol
Calcifediolum
Calcifediolum [INN-Latin]
Calcifidiol
Calderol
Calderol (TN)
CAS-19356-17-3
CHEBI:17933
CHEBI:94743
CHEMBL1040
CHEMBL3544909
Cholecalciferol, 25-hydroxy-
CS-0800
CS-0847
D00122
D02VPX
DB00146
Dedrogyl
Delakmin
Diaverene
Didrogyl
DM100
DR002352
DSSTox_CID_2721
DSSTox_GSID_22721
DSSTox_RID_76699
DTXSID0022721
EINECS 242-990-9
GTPL6921
Hidroferol
HMS1361G13
HMS1791G13
HMS1989G13
HMS2089L21
HMS3402G13
HY-32351
HY-32351A
Hy-D
I14-1324
IDI1_033881
JWUBBDSIWDLEOM-DTOXIADCSA-N
LMST03020246
MolPort-003-927-271
NCGC00161326-01
NCGC00161326-04
OR072800
OR096957
OR311613
P6YZ13C99Q
PubChem18824
Rayaldee
Ro 8-8892
Rovimix Hy-D
Ryaldee
s1469
SCHEMBL3296
SCHEMBL63580
Spectrum5_001931
SR-05000001468
SR-05000001468-1
ST2407990
T0WXW8F54E
Tox21_111987
U-32,070E
U-32070E
UNII-P6YZ13C99Q
UNII-T0WXW8F54E
VDY
Vitamin D, 25-hydroxy-
Vitamin D3 25-hydroxy monohydrate
W-201718
W-5159
W-5377
ZINC4474414

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
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for calcifediol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,918,940 Methods for controlled release oral dosage of a vitamin D compound ➤ Sign Up
6,340,473 Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same ➤ Sign Up
RE39079 Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Covington
US Department of Justice
Deloitte
McKinsey
UBS
Daiichi Sankyo
Mallinckrodt

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 verifification 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.