Last Updated: August 3, 2026

NITISINONE Drug Patent Profile

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When do Nitisinone patents expire, and what generic alternatives are available?

Nitisinone is a drug marketed by Eton, Medunik, Novitium Pharma, and Torrent. and is included in four NDAs.

The generic ingredient in NITISINONE is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitisinone

A generic version of NITISINONE was approved as nitisinone by NOVITIUM PHARMA on August 26^th, 2019.

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Summary for NITISINONE

US Patents:	0
Applicants:	4
NDAs:	4

US Patents and Regulatory Information for NITISINONE

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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
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201-001	May 25, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Medunik	NITISINONE	nitisinone	CAPSULE;ORAL	212390-003	May 26, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Eton	NITISINONE	nitisinone	CAPSULE;ORAL	216201-004	May 25, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Torrent	NITISINONE	nitisinone	CAPSULE;ORAL	215908-001	Jan 9, 2023		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Medunik	NITISINONE	nitisinone	CAPSULE;ORAL	212390-004	Apr 27, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Torrent	NITISINONE	nitisinone	CAPSULE;ORAL	215908-003	Jan 9, 2023		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ 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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