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

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	29
Patent Applications:	1,424
What excipients (inactive ingredients) are in CYSTEAMINE HYDROCHLORIDE?	CYSTEAMINE HYDROCHLORIDE excipients list
DailyMed Link:	CYSTEAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CYSTEAMINE HYDROCHLORIDE

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

Sponsor	Phase
Nacuity Pharmaceuticals, Inc.	Phase 1/Phase 2
Thiogenesis Therapeutics, Inc.	Phase 2
Clínica De La Costa Ltda.	Phase 2/Phase 3

See all CYSTEAMINE HYDROCHLORIDE clinical trials

Pharmacology for CYSTEAMINE HYDROCHLORIDE

Drug Class	Cystine Depleting Agent
Mechanism of Action	Cystine Disulfide Reduction

US Patents and Regulatory Information for CYSTEAMINE HYDROCHLORIDE

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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.	Exclusivity Expiration
Leadiant Biosci Inc	CYSTARAN	cysteamine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200740-001	Oct 2, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recordati Rare	CYSTADROPS	cysteamine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	211302-001	Aug 19, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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