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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

International Patents:	103
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	82
Clinical Trials:	11
Patent Applications:	2,373
Formulation / Manufacturing:	see details
DailyMed Link:	calcifediol at DailyMed

Pharmacology for calcifediol

Ingredient-type	Cholecalciferol
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

(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
Opko Ireland Global	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Opko Ireland Global	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes

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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
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-002	Approved Prior to Jan 1, 1982
Organon Usa Inc	CALDEROL	calcifediol	CAPSULE;ORAL	018312-001	Approved Prior to Jan 1, 1982

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
6,340,473	Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same
RE39079	Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same

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International Patents for calcifediol

Country	Document Number	Estimated Expiration
Canada	2882048
Australia	6071500
Turkey	200200272
Spain	2593047