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Last Updated: March 19, 2024

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RAYALDEE Drug Patent Profile


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

Rayaldee is a drug marketed by Eirgen and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and seventy-one patent family members in thirty-six 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.

DrugPatentWatch® Generic Entry Outlook for Rayaldee

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RAYALDEE
Drug patent expirations by year for RAYALDEE
Drug Prices for RAYALDEE

See drug prices for RAYALDEE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for RAYALDEE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OPKO Health, Inc.Phase 2

See all RAYALDEE clinical trials

Pharmacology for RAYALDEE
Drug ClassVitamin D3 Analog

US Patents and Regulatory Information for RAYALDEE

RAYALDEE is protected by twenty-two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RAYALDEE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RAYALDEE

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for controlled release oral dosage of a vitamin D compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SECONDARY HYPERPARATHYROIDISM IN STAGE 3/4 CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL WHILE AVOIDING PTH OVERSUPPRESSION


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CHOLESTYRAMINE


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING PHENOBARBITAL OR OTHER ANTICONVULSANTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CYP3A INHIBITORS

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D

Methods and compositions for controlled release oral dosage of a vitamin D compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN TREATING PATIENTS HAVING 25-HYDROXYVITAMIN D INSUFFICIENCY OR DEFICIENCY

Methods for controlled release oral dosage of a vitamin D compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE

Oral dosage form of 25-hydroxyvitamin D
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF CONTROLLED RELEASE 25-HYDROXYVITAMIN D IN TREATING SECONDARY HYPERPARATHYROIDISM IN PATIENTS HAVING CHRONIC KIDNEY DISEASE

Method for controlled release oral dosage of a vitamin D compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHYROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR STAGE 4

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SHPT IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE SERUM PARATHYROID HORMONE LEVEL AND CHANGE IN SERUM CONCENTRATION OF CALCIFEDIOL IN DOSE INTERVAL IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND TMAX IS INCREASED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTAINING SERUM 25-HYDROXYVITAMIN D AT A LEVEL OF AT LEAST 30 NG/ML WITH ORAL, SUSTAINED RELEASE 25-HYDROXYVITAMIN D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for RAYALDEE

When does loss-of-exclusivity occur for RAYALDEE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5576
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 14228069
Estimated Expiration: ⤷  Try a Trial

Patent: 19200268
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015023658
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 05409
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 15002659
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5246464
Estimated Expiration: ⤷  Try a Trial

Patent: 1346071
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 190178
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0201284
Estimated Expiration: ⤷  Try a Trial

Patent: 0201869
Estimated Expiration: ⤷  Try a Trial

Patent: 0211265
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 23167
Estimated Expiration: ⤷  Try a Trial

Patent: 23568
Estimated Expiration: ⤷  Try a Trial

Patent: 24393
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 23024864
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8867
Estimated Expiration: ⤷  Try a Trial

Patent: 1591809
Estimated Expiration: ⤷  Try a Trial

Patent: 1991774
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

Patent: 88638
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2014011525
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 20128
Estimated Expiration: ⤷  Try a Trial

Patent: 20362
Estimated Expiration: ⤷  Try a Trial

Patent: 56895
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 51923
Estimated Expiration: ⤷  Try a Trial

Patent: 52014
Estimated Expiration: ⤷  Try a Trial

Patent: 55591
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1456
Estimated Expiration: ⤷  Try a Trial

Patent: 4841
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 92051
Estimated Expiration: ⤷  Try a Trial

Patent: 33268
Estimated Expiration: ⤷  Try a Trial

Patent: 82832
Estimated Expiration: ⤷  Try a Trial

Patent: 16517429
Estimated Expiration: ⤷  Try a Trial

Patent: 18012737
Estimated Expiration: ⤷  Try a Trial

Patent: 19135264
Estimated Expiration: ⤷  Try a Trial

Patent: 21155460
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4092
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15012625
Estimated Expiration: ⤷  Try a Trial

Patent: 20011736
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1924
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 21007
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 151761
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015502162
Estimated Expiration: ⤷  Try a Trial

Patent: 021551127
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 5361134
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 846
Estimated Expiration: ⤷  Try a Trial

Patent: 132
Estimated Expiration: ⤷  Try a Trial

Patent: 176
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201703517V
Estimated Expiration: ⤷  Try a Trial

Patent: 201507323P
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68172
Estimated Expiration: ⤷  Try a Trial

Patent: 32773
Estimated Expiration: ⤷  Try a Trial

Patent: 50016
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1847947
Estimated Expiration: ⤷  Try a Trial

Patent: 2203003
Estimated Expiration: ⤷  Try a Trial

Patent: 140113374
Estimated Expiration: ⤷  Try a Trial

Patent: 140140004
Estimated Expiration: ⤷  Try a Trial

Patent: 190095216
Estimated Expiration: ⤷  Try a Trial

Patent: 210078463
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 09477
Estimated Expiration: ⤷  Try a Trial

Patent: 34900
Estimated Expiration: ⤷  Try a Trial

Patent: 82567
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 59753
Estimated Expiration: ⤷  Try a Trial

Patent: 1707689
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 3386
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RAYALDEE around the world.

Country Patent Number Title Estimated Expiration
Croatia P20231142 ⤷  Try a Trial
Lithuania 3332773 ⤷  Try a Trial
Singapore 10201703517V STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAYALDEE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 C202130022 Spain ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL; NATIONAL AUTHORISATION NUMBER: 85519-DE/H/5590/001/DC; DATE OF AUTHORISATION: 20201230; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE/H/5590/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20200721
2481400 132021000000071 Italy ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2968172 132021000000074 Italy ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.