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 | NA |
Feb, 2041
(15 years from now) | Active |
| US9994576 | NA |
Sep, 2033
(7 years from now) | Active |
| US9266895 | NA |
Sep, 2033
(7 years from now) | Active |
| US8940744 | NA |
Sep, 2033
(7 years from now) | Active |
| US9580427 | NA |
Mar, 2033
(7 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 | NA |
Oct, 2040
(15 years from now) | Active |
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 Corp 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 |