LITHIUM CITRATE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Lithium Citrate, and when can generic versions of Lithium Citrate launch?
Lithium Citrate is a drug marketed by Hikma, Pai Holdings Pharm, Rubicon, and Saptalis Pharms. and is included in four NDAs.
The generic ingredient in LITHIUM CITRATE is lithium citrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lithium Citrate
A generic version of LITHIUM CITRATE was approved as lithium citrate by RUBICON on August 14th, 2023.
Summary for LITHIUM CITRATE
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Clinical Trials: | 2 |
Patent Applications: | 1,478 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LITHIUM CITRATE |
DailyMed Link: | LITHIUM CITRATE at DailyMed |
Recent Clinical Trials for LITHIUM CITRATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Alphacait, LLC | Phase 2 |
Haukeland University Hospital | Phase 2 |
Pharmacology for LITHIUM CITRATE
Drug Class | Mood Stabilizer |
Anatomical Therapeutic Chemical (ATC) Classes for LITHIUM CITRATE
US Patents and Regulatory Information for LITHIUM CITRATE
LITHIUM CITRATE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting LITHIUM CITRATE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 018421-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Saptalis Pharms | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 217183-001 | Feb 29, 2024 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pai Holdings Pharm | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 070755-001 | May 21, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rubicon | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 218036-001 | Aug 14, 2023 | AA | RX | No | 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 |