Details for New Drug Application (NDA): 218436
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NDA 218436 describes RHAPSIDO, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the RHAPSIDO profile page.
The generic ingredient in RHAPSIDO is remibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the remibrutinib profile page.
The generic ingredient in RHAPSIDO is remibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the remibrutinib profile page.
Summary for 218436
| Tradename: | RHAPSIDO |
| Applicant: | Novartis |
| Ingredient: | remibrutinib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218436
Generic Entry Date for 218436*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 218436
| Mechanism of Action | Bruton's Tyrosine Kinase Inhibitors P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 218436
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RHAPSIDO | remibrutinib | TABLET;ORAL | 218436 | NDA | Novartis Pharmaceuticals Corporation | 0078-1483 | 0078-1483-20 | 60 TABLET in 1 BOTTLE (0078-1483-20) |
| RHAPSIDO | remibrutinib | TABLET;ORAL | 218436 | NDA | Novartis Pharmaceuticals Corporation | 0078-1483 | 0078-1483-92 | 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 30, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 30, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 13, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF CHRONIC AUTOIMMUNE URTICARIA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 19, 2043 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF CHRONIC SPONTANEOUS URTICARIA | ||||||||
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