Last Updated: September 24, 2026

Cystine Depleting Agent Drug Class List

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Drugs in Drug Class: Cystine Depleting Agent

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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
Recordati Rare	CYSTADROPS	cysteamine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	211302-001	Aug 19, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mylan	CYSTAGON	cysteamine bitartrate	CAPSULE;ORAL	020392-001	Aug 15, 1994		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mylan	CYSTAGON	cysteamine bitartrate	CAPSULE;ORAL	020392-002	Aug 15, 1994		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Leadiant Biosci Inc	CYSTARAN	cysteamine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200740-001	Oct 2, 2012		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	10,143,665*PED	⤷ Start Trial			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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