Last Updated: June 11, 2026

Iptacopan - Generic Drug Details

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US Patents and Regulatory Information for Iptacopan

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	11,603,363	⤷ Start Trial	Y	Y		⤷ Start Trial
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	9,682,968	⤷ Start Trial	Y	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

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