Rayaldee Patent Expiration

Rayaldee is a drug owned by Eirgen Pharma Ltd. It is protected by 17 US drug patents filed from 2016 to 2023. Out of these, 16 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2034. Details of Rayaldee's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10357502 Stabilized modified release vitamin D formulation and method of administering same
Mar, 2034

(9 years from now)

Active
US11253528 Stabilized modified release Vitamin D formulation and method of administering same
Mar, 2034

(9 years from now)

Active
US9861644 Stabilized modified release vitamin D formulation and method of administering same
Mar, 2034

(9 years from now)

Active
US10300078 Stabilized modified release vitamin D formulation and method of administering same
Mar, 2034

(9 years from now)

Active
US11801253 Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease
Sep, 2030

(5 years from now)

Active
US8426391 Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Aug, 2028

(3 years from now)

Active
US8361488 Methods and compositions for controlled release oral dosage of a vitamin D compound
Jul, 2028

(3 years from now)

Active
US11154509 Methods for controlled release oral dosage of a vitamin D compound
Apr, 2028

(3 years from now)

Active
US9408858 Method for treating secondary hyperparathyroidism in CKD
Apr, 2028

(3 years from now)

Active
US8207149 Method for treating secondary hyperparathyroidism in CKD
Apr, 2028

(3 years from now)

Active
US8778373 Methods for controlled release oral dosage of a vitamin D compound
Apr, 2028

(3 years from now)

Active
US9925147 Method for treating secondary hyperparathyroidism in CKD
Apr, 2028

(3 years from now)

Active
US9498486 Method for controlled release oral dosage of a vitamin D compound
Apr, 2028

(3 years from now)

Active
US8906410 Oral dosage form of 25-hydroxyvitamin D
Feb, 2027

(2 years from now)

Active
US9943530 Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Feb, 2027

(2 years from now)

Active
US10213442 Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Feb, 2027

(2 years from now)

Active
US6582727 Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same
Aug, 2020

(4 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rayaldee's patents.

Given below is the list of recent legal activities going on the following patents of Rayaldee.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 22 May, 2024 US9498486
Payment of Maintenance Fee, 8th Year, Large Entity 09 Feb, 2024 US9408858
Payment of Maintenance Fee, 12th Year, Large Entity 26 Dec, 2023 US8207149
Recordation of Patent eGrant 31 Oct, 2023 US11801253
Patent Issue Date Used in PTA Calculation 31 Oct, 2023 US11801253
Mail Patent eGrant Notification 31 Oct, 2023 US11801253
Recordation of Patent Grant Mailed 31 Oct, 2023 US11801253
Email Notification 31 Oct, 2023 US11801253
Patent eGrant Notification 31 Oct, 2023 US11801253
Email Notification 12 Oct, 2023 US11801253


FDA has granted several exclusivities to Rayaldee. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rayaldee, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rayaldee.

Exclusivity Information

Rayaldee holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Rayaldee's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jun 17, 2019

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Several oppositions have been filed on Rayaldee's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rayaldee's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rayaldee patents.

Rayaldee's Oppositions Filed in EPO

Rayaldee has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 21, 2021, by Dsm Nutritional Products Ag. This opposition was filed on patent number EP14717038A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP16164563A Aug, 2022 DSM Nutritional Products Ltd Granted and Under Opposition
EP19217651A Feb, 2022 DSM Nutritional Products AG Granted and Under Opposition
EP18155036A May, 2021 DSM Nutritional Products AG Granted and Under Opposition
EP14717038A Apr, 2021 DSM Nutritional Products AG Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Rayaldee is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rayaldee's family patents as well as insights into ongoing legal events on those patents.

Rayaldee's Family Patents

Rayaldee has patent protection in a total of 35 countries. It's US patent count contributes only to 17.5% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Rayaldee.

Family Patents

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Generic Launch

Generic Release Date:

Rayaldee's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 14, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Rayaldee Generics:

There are no approved generic versions for Rayaldee as of now.





About Rayaldee

Rayaldee is a drug owned by Eirgen Pharma Ltd. It is used for treating secondary hyperparathyroidism in patients with chronic kidney disease. Rayaldee uses Calcifediol as an active ingredient. Rayaldee was launched by Eirgen in 2016.

Approval Date:

Rayaldee was approved by FDA for market use on 17 June, 2016.

Active Ingredient:

Rayaldee uses Calcifediol as the active ingredient. Check out other Drugs and Companies using Calcifediol ingredient

Treatment:

Rayaldee is used for treating secondary hyperparathyroidism in patients with chronic kidney disease.

Dosage:

Rayaldee is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.03MG CAPSULE, EXTENDED RELEASE Prescription ORAL