WAYRILZ Drug Patent Profile
When do Wayrilz patents expire, and what generic alternatives are available?
Wayrilz is a drug marketed by Genzyme Corp and is included in one NDA. There are six patents protecting this drug.
The generic ingredient in WAYRILZ is rilzabrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rilzabrutinib profile page.
DrugPatentWatch® Generic Entry Outlook for Wayrilz
Wayrilz will be eligible for patent challenges on August 29, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 29, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for WAYRILZ?
- What are the global sales for WAYRILZ?
- What is Average Wholesale Price for WAYRILZ?
Summary for WAYRILZ
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 571 |
| What excipients (inactive ingredients) are in WAYRILZ? | WAYRILZ excipients list |
| DailyMed Link: | WAYRILZ at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WAYRILZ
Generic Entry Date for WAYRILZ*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for WAYRILZ
WAYRILZ is protected by seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of WAYRILZ is ⤷ Start Trial.
This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685-001 | Aug 29, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for WAYRILZ
See the table below for patents covering WAYRILZ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 120803 | ⤷ Start Trial | |
| Australia | 2020405096 | ⤷ Start Trial | |
| Brazil | 112022011516 | ⤷ Start Trial | |
| Canada | 3162219 | ⤷ Start Trial | |
| China | 115515687 | ⤷ Start Trial | |
| Colombia | 2022008023 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WAYRILZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3181567 | C20260015 | Finland | ⤷ Start Trial | |
| 3181567 | 301380 | Netherlands | ⤷ Start Trial | PRODUCT NAME: RILZABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/25/1974 20251223 |
| 3181567 | CR 2026 00022 | Denmark | ⤷ Start Trial | PRODUCT NAME: RILZABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/25/1974 20261223 |
| 3181567 | PA2026520 | Lithuania | ⤷ Start Trial | PRODUCT NAME: WAYRILZ - RILZABRUTINIBAS; REGISTRATION NO/DATE: EU/1/25/1974 20251222 |
| 3181567 | LUC50052 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: RILZABRUTINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/25/1974 20251223 |
| 3181567 | 202640019 | Slovenia | ⤷ Start Trial | PRODUCT NAME: RILZABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/25/1974; DATE OF NATIONAL AUTHORISATION: 20251222; AUTHORITY FOR NATIONAL AUTHORISATION: EU |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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