Wayrilz is a drug owned by Genzyme Corp. It is protected by 6 US drug patents filed in 2025 out of which none have expired yet. Wayrilz's patents will be open to challenges from 29 August, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 20, 2041. Details of Wayrilz'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. | |||
| US11708370 | Solid Forms Of 2-[3-[4-Amino-3-(2-Fluoro-4-Phenoxyphenyl)Pyrazolo[3,4-D]Pyrimidin-1-Yl]Piperidine-1-Carbonyl]-4-Methyl-4-[4-(Oxetan-3-Yl)Piperazin-1-Yl]Pent-2-Enenitrile |
Feb, 2041
(14 years from now) | Active |
| US9994576 | Substituted Pyrazolo[3,4-D]Pyrimidines As Kinase Inhibitors |
Sep, 2033
(7 years from now) | Active |
| US9266895 | Substituted Pyrazolo[3,4-D]Pyrimidines As Kinase Inhibitors |
Sep, 2033
(7 years from now) | Active |
| US8940744 | Pyrazolopyrimidine Compounds As Kinase Inhibitors |
Sep, 2033
(7 years from now) | Active |
| US9580427 | Kinase Inhibitors |
Mar, 2033
(6 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). | |||
| US12178818 | Methods For Treating Immune Thrombocytopenia By Administering (R)-2-[3-[4-Amino-3-(2-Fluoro-4-Phenoxy-Phenyl)Pyrazolo[3,4-D]Pyrimidin-1-Yl]Piperidine-1-Carbonyl]-4-Methyl-4-[4-(Oxetan-3-Yl)Piperazin-1-Yl]Pent-2-Enenitrile |
Oct, 2040
(14 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 Wayrilz's patents.
Latest Legal Activities on Wayrilz's Patents
Given below is the list of recent legal activities going on the following patents of Wayrilz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Sep, 2025 | US9994576 |
| Patent eCofC Notification | 06 May, 2025 | US9580427 |
| Mail Patent eCofC Notification | 06 May, 2025 | US9580427 |
| Email Notification | 06 May, 2025 | US9580427 |
| Recordation of Patent eCertificate of Correction | 06 May, 2025 | US9580427 |
| Post Issue Communication - Certificate of Correction | 29 Jan, 2025 | US9580427 |
| Recordation of Patent eGrant | 31 Dec, 2024 | US12178818 |
| Patent eGrant Notification | 31 Dec, 2024 | US12178818 |
| Mail Patent eGrant Notification | 31 Dec, 2024 | US12178818 |
| Patent Issue Date Used in PTA Calculation | 31 Dec, 2024 | US12178818 |
FDA has granted several exclusivities to Wayrilz. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Wayrilz, 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
Wayrilz.
Exclusivity Information
Wayrilz holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Wayrilz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 29, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Wayrilz 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 Wayrilz's family patents as well as insights into
ongoing legal events
on those patents.
Wayrilz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Wayrilz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 20, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wayrilz Generics:
There are no approved generic versions for Wayrilz as of now.
About Wayrilz
Wayrilz is a drug owned by Genzyme Corp. Wayrilz uses Rilzabrutinib as an active ingredient. Wayrilz was launched by Genzyme in 2025.
Approval Date:
Wayrilz was approved by FDA for market use on 29 August, 2025.
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 Wayrilz is 29 August, 2025, its NCE-1 date is estimated to be 29 August, 2029.
Active Ingredient:
Wayrilz uses Rilzabrutinib as the active ingredient. Check out other Drugs and Companies using Rilzabrutinib ingredient
Dosage:
Wayrilz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG | TABLET | Prescription | ORAL |