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
(1 year, 3 months from now) | Active |
| US9504699 | Delayed-release glucocorticoid treatment of rheumatoid disease |
Aug, 2027
(9 months from now) | Active |
| US8394407 | Delayed release tablet with defined core geometry |
Apr, 2024
(2 years ago) |
Expired
|
| US8309124 | Delayed release tablet with defined core geometry |
Apr, 2024
(2 years ago) |
Expired
|
| US9186332 | Delayed release tablet with defined core geometry |
Apr, 2024
(2 years ago) |
Expired
|
| US9040085 | Delayed release tablet with defined core geometry |
Apr, 2024
(2 years ago) |
Expired
|
| US6488960 | Corticosteroid formulation |
Mar, 2020
(6 years ago) |
Expired
|
| US6677326 | Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration |
Mar, 2020
(6 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 |
|---|---|---|
 | ||
| Expire Patent | 14 Apr, 2025 | US8394407 (Litigated) |
| Refund - Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jan, 2025 | US8309124 (Litigated) |
| Refund - 11.5 yr surcharge - late pmt w/in 6 mo, Large Entity | 14 Jan, 2025 | US8309124 (Litigated) |
| Maintenance Fee Reminder Mailed | 28 Oct, 2024 | US8394407 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2024 | US8309124 (Litigated) |
| 11.5 yr surcharge- late pmt w/in 6 mo, 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 |
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
Clinical Trials
Recent Clinical Trials on Rayos:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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. 60 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 26 Nov, 2012 | 23 Apr, 2024 | Extinguished Deferred | 25 Apr, 2017 | Less | |
| 26 Nov, 2012 | 07 Jan, 2028 | Non-Forfeiture Deferred | 25 Apr, 2017 | Less |
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 |