Rayos is a drug owned by Horizon Therapeutics Usa Inc. It is protected by 8 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 07, 2028. Details of Rayos'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). | |||
| US8168218 | Delayed release tablet with defined core geometry |
Jan, 2028
(2 years from now) | Active |
| US9504699 | Delayed-release glucocorticoid treatment of rheumatoid disease |
Aug, 2027
(2 years from now) | Active |
| US8394407 | Delayed release tablet with defined core geometry |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| US8309124 | Delayed release tablet with defined core geometry |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| US9186332 | Delayed release tablet with defined core geometry |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| US9040085 | Delayed release tablet with defined core geometry |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| US6488960 | Corticosteroid formulation |
Mar, 2020
(5 years ago) |
Expired
|
| US6677326 | Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration |
Mar, 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 Rayos's patents.
Latest Legal Activities on Rayos's Patents
Given below is the list of recent legal activities going on the following patents of Rayos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 24 May, 2024 | US8309124 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2024 | US8309124 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 May, 2024 | US9504699 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Oct, 2023 | US8168218 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 May, 2023 | US9186332 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9040085 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Aug, 2020 | US8394407 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 May, 2020 | US9504699 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2020 | US8309124 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Oct, 2019 | US8168218 (Litigated) |
FDA has granted several exclusivities to Rayos. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rayos, 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 Rayos.
Exclusivity Information
Rayos holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Rayos's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-128) | Jul 26, 2015 |
Several oppositions have been filed on Rayos'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 Rayos's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rayos patents.
Rayos's Oppositions Filed in EPO
Rayos has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 31, 2013, by Laboratorios Liconsa, S.A.. This opposition was filed on patent number EP07801510A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07801510A | Jul, 2013 | Laboratorios Liconsa, S.A. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Rayos 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 Rayos's family patents as well as insights into ongoing legal events on those patents.
Rayos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rayos's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 07, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rayos Generic API suppliers:
Prednisone is the generic name for the brand Rayos. 59 different companies have already filed for the generic of Rayos, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rayos's generic
How can I launch a generic of Rayos before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rayos's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rayos's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rayos -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, and 5 mg | 26 Nov, 2012 | 1 | 25 Apr, 2017 | Deferred |
About Rayos
Rayos is a drug owned by Horizon Therapeutics Usa Inc. It is used for managing a variety of inflammatory and autoimmune conditions including rheumatoid arthritis and allergic reactions. Rayos uses Prednisone as an active ingredient. Rayos was launched by Horizon in 2012.
Approval Date:
Rayos was approved by FDA for market use on 26 July, 2012.
Active Ingredient:
Rayos uses Prednisone as the active ingredient. Check out other Drugs and Companies using Prednisone ingredient
Treatment:
Rayos is used for managing a variety of inflammatory and autoimmune conditions including rheumatoid arthritis and allergic reactions.
Dosage:
Rayos is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| 1MG | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| 2MG | TABLET, DELAYED RELEASE | Discontinued | ORAL |