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Last Updated: May 21, 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-two 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
International Patents:172
US Patents:16
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 1
Patent Applications: 3,420
Formulation / Manufacturing:see details
Drug Prices: Drug price information for RAYALDEE
What excipients (inactive ingredients) are in RAYALDEE?RAYALDEE excipients list
DailyMed Link:RAYALDEE at DailyMed
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*:
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Constraining patent/regulatory exclusivity:
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NDA:
208010
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
Anatomical Therapeutic Chemical (ATC) Classes for RAYALDEE
A11CC Vitamin D and analogues
A11C VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
A11 VITAMINS
A Alimentary tract and metabolism
H05BX Other anti-parathyroid agents
H05B ANTI-PARATHYROID AGENTS
H05 CALCIUM HOMEOSTASIS
H Systemic hormonal preparations, excluding sex hormones and insulins

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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


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


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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE

Oral dosage form of 25-hydroxyvitamin D
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF SUSTAINED OR EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR 4

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treating secondary hyperparathyroidism in CKD
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTAINING SERUM 25-HYDROXYVITAMIN D AT A LEVEL OF AT LEAST 30 NG/ML WITH ORAL, SUSTAINED RELEASE 25-HYDROXYVITAMIN D

Glossary
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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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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: ⤷  Sign Up

Australia

Patent: 14228069
Estimated Expiration: ⤷  Sign Up

Patent: 19200268
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Brazil

Patent: 2015023658
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 05409
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 15002659
Estimated Expiration: ⤷  Sign Up

China

Patent: 5246464
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Patent: 1346071
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Costa Rica

Patent: 190178
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Croatia

Patent: 0201284
Estimated Expiration: ⤷  Sign Up

Patent: 0201869
Estimated Expiration: ⤷  Sign Up

Patent: 0211265
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 23167
Estimated Expiration: ⤷  Sign Up

Patent: 23568
Estimated Expiration: ⤷  Sign Up

Patent: 24393
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 23024864
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8867
Estimated Expiration: ⤷  Sign Up

Patent: 1591809
Estimated Expiration: ⤷  Sign Up

Patent: 1991774
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
Estimated Expiration: ⤷  Sign Up

Patent: 88638
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2014011525
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 20128
Estimated Expiration: ⤷  Sign Up

Patent: 20362
Estimated Expiration: ⤷  Sign Up

Patent: 56895
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 51923
Estimated Expiration: ⤷  Sign Up

Patent: 52014
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Patent: 55591
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1456
Estimated Expiration: ⤷  Sign Up

Patent: 4841
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 92051
Estimated Expiration: ⤷  Sign Up

Patent: 33268
Estimated Expiration: ⤷  Sign Up

Patent: 82832
Estimated Expiration: ⤷  Sign Up

Patent: 16517429
Estimated Expiration: ⤷  Sign Up

Patent: 18012737
Estimated Expiration: ⤷  Sign Up

Patent: 19135264
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Patent: 21155460
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Lithuania

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
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Malaysia

Patent: 4092
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 15012625
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Patent: 20011736
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New Zealand

Patent: 1924
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Norway

Patent: 21007
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Peru

Patent: 151761
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Philippines

Patent: 015502162
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Patent: 021551127
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Poland

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 5361134
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Serbia

Patent: 846
Estimated Expiration: ⤷  Sign Up

Patent: 132
Estimated Expiration: ⤷  Sign Up

Patent: 176
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201703517V
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Patent: 201507323P
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Slovenia

Patent: 68172
Estimated Expiration: ⤷  Sign Up

Patent: 32773
Estimated Expiration: ⤷  Sign Up

Patent: 50016
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South Korea

Patent: 1847947
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Patent: 2203003
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Patent: 140113374
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Patent: 140140004
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Patent: 190095216
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Patent: 210078463
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Spain

Patent: 09477
Estimated Expiration: ⤷  Sign Up

Patent: 34900
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Patent: 82567
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Taiwan

Patent: 59753
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Patent: 1707689
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Ukraine

Patent: 3386
Estimated Expiration: ⤷  Sign Up

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
Portugal 2148661 ⤷  Sign Up
European Patent Office 3225243 PROCÉDÉ SÛR ET EFFICACE DE TRAITEMENT ET DE PRÉVENTION DE L'HYPERPARATHYROÏDISME SECONDAIRE DANS UNE MALADIE RÉNALE CHRONIQUE (METHOD OF SAFELY AND EFFECTIVELY TREATING AND PREVENTING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE) ⤷  Sign Up
Japan 2010525078 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for RAYALDEE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 132021000000071 Italy ⤷  Sign Up PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2481400 122020000079 Germany ⤷  Sign Up PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721
2481400 C202130022 Spain ⤷  Sign Up 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
>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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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