Details for New Drug Application (NDA): 218276
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NDA 218276 describes FABHALTA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the FABHALTA profile page.
The generic ingredient in FABHALTA is iptacopan hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iptacopan hydrochloride profile page.
The generic ingredient in FABHALTA is iptacopan hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iptacopan hydrochloride profile page.
Summary for 218276
| Tradename: | FABHALTA |
| Applicant: | Novartis |
| Ingredient: | iptacopan hydrochloride |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218276
Generic Entry Date for 218276*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 218276
| Mechanism of Action | Complement Factor B Inhibitors |
Suppliers and Packaging for NDA: 218276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276 | NDA | Novartis Pharmaceuticals Corporation | 0078-1189 | 0078-1189-20 | 60 CAPSULE in 1 BOTTLE (0078-1189-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Dec 5, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 7, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR THE REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR)>/= 1.5 G/G | ||||||||
| Regulatory Exclusivity Expiration: | Dec 5, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 20, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH COMPLEMENT 3 GLOMERULOPATHY (C3G), TO REDUCE PROTEINURIA | ||||||||
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