LITHIUM CITRATE Drug Patent Profile
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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 Sciegen Pharms Inc. 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. Three 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.
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Questions you can ask:
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Summary for LITHIUM CITRATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 3 |
| Patent Applications: | 2,402 |
| 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 |
|---|---|
| Mental Health Services in the Capital Region, Denmark | Phase 4 |
| Alphacait, LLC | Phase 2 |
| Haining Health-Coming Biotech Co., Ltd. | 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: ⤷ Sign Up
| 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 | ||||
| Sciegen Pharms Inc | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 217183-001 | Mar 18, 2024 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pai Holdings Pharm | LITHIUM CITRATE | lithium citrate | SYRUP;ORAL | 070755-001 | May 21, 1986 | 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 |
