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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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McKesson
Colorcon
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Teva
Julphar
Queensland Health
Baxter

Generated: September 18, 2018

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RAYALDEE Drug Profile

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Which patents cover Rayaldee, and what generic alternatives are available?

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

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.

Drug patent expirations by year for RAYALDEE
Pharmacology for RAYALDEE
Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog
Medical Subject Heading (MeSH) Categories 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
(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-[(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,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 (Calcifediol)
25-Hydroxycholecalciferol, >=98% (HPLC)
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, 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
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
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
D02VPX
DB00146
Dedrogyl
Delakmin
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-D
IDI1_033881
JWUBBDSIWDLEOM-DTOXIADCSA-N
LMST03020246
MolPort-003-927-271
NCGC00161326-01
NCGC00161326-04
OR096957
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Opko Ireland Global RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Non-Orange Book US Patents for RAYALDEE

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

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Moodys
McKesson
Colorcon
US Department of Justice
Teva
Julphar
Queensland Health
Baxter

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.