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Last Updated: September 25, 2022

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 fifteen patents protecting this drug.

This drug has one hundred and forty-nine 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.

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 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.

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

US Patents and Regulatory Information for RAYALDEE

RAYALDEE is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RAYALDEE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized modified release vitamin D formulation and method of administering same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for controlled release oral dosage of a vitamin D compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating secondary hyperparathyroidism in CKD
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Oral dosage form of 25-hydroxyvitamin D
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating secondary hyperparathyroidism in CKD
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating secondary hyperparathyroidism in CKD
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 14228069
Estimated Expiration: See Plans and Pricing

Patent: 19200268
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015023658
Estimated Expiration: See Plans and Pricing

Canada

Patent: 05409
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15002659
Estimated Expiration: See Plans and Pricing

China

Patent: 5246464
Estimated Expiration: See Plans and Pricing

Patent: 1346071
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 190178
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0201284
Estimated Expiration: See Plans and Pricing

Patent: 0201869
Estimated Expiration: See Plans and Pricing

Patent: 0211265
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8867
Estimated Expiration: See Plans and Pricing

Patent: 1591809
Estimated Expiration: See Plans and Pricing

Patent: 1991774
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

Patent: 88638
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2014011525
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 20128
Estimated Expiration: See Plans and Pricing

Patent: 20362
Estimated Expiration: See Plans and Pricing

Patent: 56895
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 51923
Estimated Expiration: See Plans and Pricing

Patent: 52014
Estimated Expiration: See Plans and Pricing

Patent: 55591
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1456
Estimated Expiration: See Plans and Pricing

Patent: 4841
Estimated Expiration: See Plans and Pricing

Japan

Patent: 92051
Estimated Expiration: See Plans and Pricing

Patent: 33268
Estimated Expiration: See Plans and Pricing

Patent: 16517429
Estimated Expiration: See Plans and Pricing

Patent: 18012737
Estimated Expiration: See Plans and Pricing

Patent: 19135264
Estimated Expiration: See Plans and Pricing

Patent: 21155460
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15012625
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1924
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21007
Estimated Expiration: See Plans and Pricing

Peru

Patent: 151761
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015502162
Estimated Expiration: See Plans and Pricing

Patent: 021551127
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 5361134
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 846
Estimated Expiration: See Plans and Pricing

Patent: 132
Estimated Expiration: See Plans and Pricing

Patent: 176
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201703517V
Estimated Expiration: See Plans and Pricing

Patent: 201507323P
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68172
Estimated Expiration: See Plans and Pricing

Patent: 32773
Estimated Expiration: See Plans and Pricing

Patent: 50016
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1847947
Estimated Expiration: See Plans and Pricing

Patent: 2203003
Estimated Expiration: See Plans and Pricing

Patent: 140113374
Estimated Expiration: See Plans and Pricing

Patent: 140140004
Estimated Expiration: See Plans and Pricing

Patent: 190095216
Estimated Expiration: See Plans and Pricing

Patent: 210078463
Estimated Expiration: See Plans and Pricing

Spain

Patent: 09477
Estimated Expiration: See Plans and Pricing

Patent: 34900
Estimated Expiration: See Plans and Pricing

Patent: 82567
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 59753
Estimated Expiration: See Plans and Pricing

Patent: 1707689
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3386
Estimated Expiration: See Plans and Pricing

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
Turkey 200200272 See Plans and Pricing
Spain 2882567 See Plans and Pricing
Japan 2021155460 安定化調整放出ビタミンD製剤及びその投与方法 (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING THE SAME) See Plans and Pricing
Serbia 62176 STABILIZOVANA FORMULACIJA VITAMINA D SA MODIFIKOVANIM OSLOBAĐANJEM I POSTUPAK ZA NJENU PRIMENU (STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME) See Plans and Pricing
Israel 241456 פורמולציה מיוצבת ובעלת שחרור מבוקר של ויטמין, d , ושיטות לנתינתה (Stabilized modified release vitamin d formulation and method of administring same) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAYALDEE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2481400 132021000000071 Italy See Plans and Pricing PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2968172 CA 2021 00005 Denmark See Plans and Pricing PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2481400 C02481400/01 Switzerland See Plans and Pricing PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020
2968172 122021000009 Germany See Plans and Pricing PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2481400 C202130022 Spain See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Harvard Business School
Mallinckrodt
McKesson
Medtronic

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.