Skyclarys is a drug owned by Reata Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2023 to 2024 out of which none have expired yet. Skyclarys's patents will be open to challenges from 28 February, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 24, 2033. Details of Skyclarys's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8993640 | 2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof |
Apr, 2033
(8 years from now) | Active |
| US9701709 | 2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof |
Apr, 2033
(8 years from now) | Active |
| US8124799 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 |
Dec, 2029
(4 years from now) | Active |
| US9670147 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 |
Apr, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11091430 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at c-17 |
Apr, 2029
(4 years from now) | Active |
| US8440854 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17 |
Apr, 2029
(4 years from now) | Active |
| US11919838 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 |
Apr, 2029
(4 years from now) | Active |
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 Skyclarys's patents.
Latest Legal Activities on Skyclarys's Patents
Given below is the list of recent legal activities going on the following patents of Skyclarys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US8124799 |
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US8440854 |
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US9670147 |
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US9701709 |
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US11091430 |
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US8993640 |
| Recordation of Patent eGrant | 05 Mar, 2024 | US11919838 |
| Recordation of Patent Grant Mailed Critical | 05 Mar, 2024 | US11919838 |
| Patent eGrant Notification | 05 Mar, 2024 | US11919838 |
| Email Notification Critical | 05 Mar, 2024 | US11919838 |
FDA has granted several exclusivities to Skyclarys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Skyclarys, 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 Skyclarys.
Exclusivity Information
Skyclarys holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Skyclarys's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 28, 2028 |
| Orphan Drug Exclusivity(ODE-427) | Feb 28, 2030 |
US patents provide insights into the exclusivity only within the United States, but Skyclarys 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 Skyclarys's family patents as well as insights into ongoing legal events on those patents.
Skyclarys's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Skyclarys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 24, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Skyclarys Generics:
There are no approved generic versions for Skyclarys as of now.
About Skyclarys
Skyclarys is a drug owned by Reata Pharmaceuticals Inc. It is used for treating Friedrich's ataxia by activating the NRF2 pathway to reduce oxidative stress in adults and adolescents aged 16 years and older. Skyclarys uses Omaveloxolone as an active ingredient. Skyclarys was launched by Reata Pharms in 2023.
Approval Date:
Skyclarys was approved by FDA for market use on 28 February, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Skyclarys is 28 February, 2023, its NCE-1 date is estimated to be 28 February, 2027.
Active Ingredient:
Skyclarys uses Omaveloxolone as the active ingredient. Check out other Drugs and Companies using Omaveloxolone ingredient
Treatment:
Skyclarys is used for treating Friedrich's ataxia by activating the NRF2 pathway to reduce oxidative stress in adults and adolescents aged 16 years and older.
Dosage:
Skyclarys is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | CAPSULE | Prescription | ORAL |