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
(8 years from now) | Active |
| US11253528 | Stabilized modified release Vitamin D formulation and method of administering same |
Mar, 2034
(8 years from now) | Active |
| US9861644 | Stabilized modified release vitamin D formulation and method of administering same |
Mar, 2034
(8 years from now) | Active |
| US10300078 | Stabilized modified release vitamin D formulation and method of administering same |
Mar, 2034
(8 years from now) | Active |
| US11801253 | Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease |
Sep, 2030
(4 years from now) | Active |
| US8426391 | Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 |
Aug, 2028
(2 years from now) | Active |
| US8361488 | Methods and compositions for controlled release oral dosage of a vitamin D compound |
Jul, 2028
(2 years from now) | Active |
| US11154509 | Methods for controlled release oral dosage of a vitamin D compound |
Apr, 2028
(2 years from now) | Active |
| US8207149 | Method for treating secondary hyperparathyroidism in CKD |
Apr, 2028
(2 years from now) | Active |
| US9925147 | Method for treating secondary hyperparathyroidism in CKD |
Apr, 2028
(2 years from now) | Active |
| US9408858 | Method for treating secondary hyperparathyroidism in CKD |
Apr, 2028
(2 years from now) | Active |
| US8778373 | Methods for controlled release oral dosage of a vitamin D compound |
Apr, 2028
(2 years from now) | Active |
| US9498486 | Method for controlled release oral dosage of a vitamin D compound |
Apr, 2028
(2 years from now) | Active |
| US8906410 | Oral dosage form of 25-hydroxyvitamin D |
Feb, 2027
(1 year, 3 months from now) | Active |
| US9943530 | Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 |
Feb, 2027
(1 year, 3 months from now) | Active |
| US10213442 | Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 |
Feb, 2027
(1 year, 3 months from now) | Active |
| US6582727 | Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same |
Aug, 2020
(5 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.
Latest 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 |
|---|---|---|
 | ||
| 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
Critical | 31 Oct, 2023 | US11801253 |
| Mail Patent eGrant Notification | 31 Oct, 2023 | US11801253 |
| Recordation of Patent Grant Mailed
Critical | 31 Oct, 2023 | US11801253 |
| Email Notification
Critical | 31 Oct, 2023 | US11801253 |
| Patent eGrant Notification | 31 Oct, 2023 | US11801253 |
| Email Notification
Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |