Last Updated: November 8, 2026

Details for Patent: 10,548,859

Name: Drug Patent Intelligence for US Patent 10548859
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which drugs does patent 10,548,859 protect, and when does it expire?

Patent 10,548,859 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 10,548,859

Title:	Methods for storing Cysteamine formulations and related methods of treatment
Abstract:	Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Inventor(s):	Michael Desjardin, Mark Johnson
Assignee:	Horizon Therapeutics US Holding LLC , Horizon Pharmaceutical LLC
Application Number:	US16/402,599
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,548,859
Patent Claim Types: see list of patent claims	Use; Composition;

Drugs Protected by US Patent 10,548,859

Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	⤷ Start Trial	⤷ 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.	>Patented / Exclusive Use	>Submissiondate

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