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Last Updated: December 15, 2019

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RAYALDEE Drug Profile

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When do Rayaldee patents expire, and what generic alternatives are available?

Rayaldee is a drug marketed by Opko Ireland Global and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and twenty-five patent family members in thirty-four countries.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

US ANDA Litigation and Generic Entry Outlook for Rayaldee

Rayaldee was eligible for patent challenges on December 31st, 1968.

Drug patent expirations by year for RAYALDEE
Drug Prices for RAYALDEE

See drug prices for RAYALDEE

Pharmacology for RAYALDEE
Synonyms for RAYALDEE
(?R,1R,3aS,4E,7aR)-4-[(2Z)-2-[(5S)-5-hydroxy-2-methylenecyclohexylidene]ethylidene]octahydro-?,?,?,7a-tetramethyl-1H-indene-1-pentanol
(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
(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,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
(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
1384584-62-6
19356-17-3
25-(OH)Vitamin D3
25-hydroxy-cholecalciferol
25-Hydroxycholecalciferol
25-Hydroxycholecalciferol monohydrate
25-Hydroxycholecalciferol, >=98% (HPLC)
25-Hydroxycholescalciferol
25-Hydroxyvitamin D
25-hydroxyvitamin D3
25-hydroxyvitamin D3 / 25-hydroxycholecalciferol / calcidiol
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)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
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
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, (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
AC1NR2WF
ACT06833
AKOS015965097
B91135EC-8937-4D8B-A533-CCD82F33C1B0
BC219279
BCP9000472
BCPP000306
BML2-E02
BRD-K77175907-001-01-5
BSPBio_001411
C01561
Calcidiol
Calcidiol;Didrogyl;Hidroferol
Calcifediol
Calcifediol [INN]
Calcifediol anhydrous
Calcifediol, European Pharmacopoeia (EP) Reference Standard
Calcifediol, United States Pharmacopeia (USP) Reference Standard
Calcifediolum
Calcifediolum [INN-Latin]
Calcifidiol
Calderol
CAS-19356-17-3
CHEBI:17933
CHEBI:94743
CHEMBL1040
Cholecalciferol, 25-hydroxy-
CS-0800
DB00146
Dedrogyl
Delakmin
Didrogyl
DM100
DSSTox_CID_2721
DSSTox_GSID_22721
DSSTox_RID_76699
DTXSID0022721
EINECS 242-990-9
GTPL6921
Hidroferol
HMS1361G13
HMS1791G13
HMS1989G13
HMS2089L21
HMS3402G13
HY-32351
Hy-D
IDI1_033881
JWUBBDSIWDLEOM-DTOXIADCSA-N
LMST03020246
MFCD00867077
MolPort-003-927-271
NCGC00161326-01
NCGC00161326-04
PubChem18824
Ro 8-8892
Rovimix Hy-D
Ryaldee
s1469
SCHEMBL3296
Spectrum5_001931
SR-05000001468
SR-05000001468-1
ST2407990
T0WXW8F54E
Tox21_111987
U-32070E
UNII-T0WXW8F54E
VDY
Vitamin D, 25-hydroxy-
W-201718
W-5159
ZINC4474414

US Patents and Regulatory Information for RAYALDEE

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 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
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   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Colorcon
Mallinckrodt
Express Scripts
McKesson

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