Lithium citrate - Generic Drug Details

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What are the generic sources for lithium citrate and what is the scope of patent protection?

Lithium citrate is the generic ingredient in two branded drugs marketed by Hikma, Pai Holdings Pharm, Rubicon, Sciegen Pharms Inc, and Solvay, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for lithium citrate. Three suppliers are listed for this compound.

Summary for lithium citrate

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	3
Patent Applications:	6,813
Drug Prices:	Drug price trends for lithium citrate
DailyMed Link:	lithium citrate at DailyMed

See drug prices for lithium citrate

Recent Clinical Trials for lithium citrate

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

Sponsor	Phase
Mental Health Services in the Capital Region, Denmark	Phase 4
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all lithium citrate clinical trials

Pharmacology for lithium citrate

Drug Class	Mood Stabilizer

Anatomical Therapeutic Chemical (ATC) Classes for lithium citrate

N05AN	Lithium
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for lithium citrate

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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
Hikma	LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	018421-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	LITHONATE	lithium citrate	SYRUP;ORAL	017672-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	LITHIUM CITRATE	lithium citrate	SYRUP;ORAL	218036-001	Aug 14, 2023	AA	RX	No	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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