Details for New Drug Application (NDA): 219685
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NDA 219685 describes WAYRILZ, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the WAYRILZ profile page.
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.
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.
Summary for 219685
| Tradename: | WAYRILZ |
| Applicant: | Genzyme Corp |
| Ingredient: | rilzabrutinib |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219685
Generic Entry Date for 219685*:
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 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.
Suppliers and Packaging for NDA: 219685
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685 | NDA | Genzyme Corporation | 58468-0251 | 58468-0251-5 | 2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) |
| WAYRILZ | rilzabrutinib | TABLET;ORAL | 219685 | NDA | Genzyme Corporation | 58468-0251 | 58468-0251-6 | 1 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Aug 29, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 29, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 29, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 20, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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