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Last Updated: March 28, 2024

CYSTEAMINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for cysteamine hydrochloride and what is the scope of freedom to operate?

Cysteamine hydrochloride is the generic ingredient in two branded drugs marketed by Recordati Rare and Leadiant Biosci Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CYSTEAMINE HYDROCHLORIDE
Recent Clinical Trials for CYSTEAMINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thiogenesis Therapeutics, Inc.Phase 2
EmeraMedPhase 2/Phase 3
Clínica De La Costa Ltda.Phase 2/Phase 3

See all CYSTEAMINE HYDROCHLORIDE clinical trials

Pharmacology for CYSTEAMINE HYDROCHLORIDE

US Patents and Regulatory Information for CYSTEAMINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leadiant Biosci Inc CYSTARAN cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200740-001 Oct 2, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare CYSTADROPS cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 211302-001 Aug 19, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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