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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Queensland Health
Merck
US Army
Farmers Insurance
Federal Trade Commission
Boehringer Ingelheim
Colorcon
Argus Health

Generated: July 18, 2018

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RAYALDEE Drug Profile

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When do Rayaldee patents expire, and when can generic versions of Rayaldee launch?

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

This drug has one hundred and three patent family members in thirty-three 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.
Summary for RAYALDEE
International Patents:103
US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 57
Patent Applications: 1,409
Formulation / Manufacturing:see details
DailyMed Link:RAYALDEE at DailyMed
Drug patent expirations by year for RAYALDEE
Generic Entry Opportunity Date for RAYALDEE
Generic Entry Date for RAYALDEE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
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:

Harvard Business School
Merck
Queensland Health
AstraZeneca
McKinsey
UBS
Express Scripts
Cerilliant
McKesson

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