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Last Updated: December 15, 2025

LITHIUM CITRATE - Generic Drug Details


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Summary for LITHIUM CITRATE
Drug Prices for LITHIUM CITRATE

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Recent Clinical Trials for LITHIUM CITRATE

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SponsorPhase
Mental Health Services in the Capital Region, DenmarkPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2

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Pharmacology for LITHIUM CITRATE
Drug ClassMood Stabilizer
Anatomical Therapeutic Chemical (ATC) Classes for LITHIUM CITRATE

US Patents and Regulatory Information for LITHIUM CITRATE

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rubicon Research LITHIUM CITRATE lithium citrate SYRUP;ORAL 218036-001 Aug 14, 2023 AA RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Solvay LITHONATE lithium citrate SYRUP;ORAL 017672-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pai Holdings Pharm LITHIUM CITRATE lithium citrate SYRUP;ORAL 070755-001 May 21, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms Inc LITHIUM CITRATE lithium citrate SYRUP;ORAL 217183-001 Mar 18, 2024 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Lithium Citrate

Last updated: July 27, 2025

Introduction

Lithium citrate, a pharmaceutical salt of lithium, is primarily utilized within medical settings for mood stabilization and management of bipolar disorder. Its market landscape is shaped by evolving therapeutic needs, regulatory frameworks, and manufacturing innovations. This comprehensive analysis explores the market dynamics and financial trajectory of lithium citrate, emphasizing key drivers, challenges, and future outlooks.

Pharmacological Profile and Clinical Applications

Lithium citrate functions as an oral lithium salt, offering a bioavailable form suited for psychiatric treatment. It acts as a mood stabilizer, with efficacy in reducing the frequency and severity of manic episodes associated with bipolar disorder. Lithium’s mechanism involves modulation of neurotransmitter release and neuroprotective effects, making it a standard of care in psychiatric management [1].

While lithium carbonate remains the dominant prescription form globally, lithium citrate's particular advantages include a more rapid onset of action and perhaps a more tolerable side-effect profile, although its usage is less widespread. Its administration is primarily in hospital or controlled outpatient settings, adhering to strict plasma concentration monitoring to mitigate lithium toxicity risks.

Market Dynamics

Demand Drivers

  • Global Rise in Bipolar Disorder Incidence: As reported by WHO, bipolar disorder affects approximately 1-2% of the global population, with increasing recognition and diagnosis actively expanding treatment markets [2]. This trend directly fuels demand for lithium-based therapies, including lithium citrate, especially in healthcare systems emphasizing mood stabilization.

  • Shift Toward Long-term Psychiatric Management: The increasing adoption of maintenance therapy to prevent relapse sustains demand for lithium salts. Lithium citrate, offered as part of comprehensive psychiatric treatment plans, aligns with this shift.

  • Regulatory and Publication Trends: Regulatory approvals and clinical guidelines endorse lithium’s role in bipolar disorder, reinforcing market confidence. Recent studies spotlight lithium's neuroprotective properties and potential anti-suicidal effects, broadening its therapeutic appeal [3].

Supply Dynamics

  • Manufacturing Landscape: Lithium citrate is primarily produced by specialized pharmaceutical companies. The drug’s manufacturing involves high purity standards, with complex synthesis processes that influence supply stability and cost.

  • Raw Material Constraints: Lithium is a finite resource mainly extracted from brine pools and mineral deposits. Fluctuations in lithium supply, driven by geopolitical factors and extraction costs, impact production capacity and pricing.

Competitive Landscape

  • Market Positioning: Lithium carbonate dominates the lithium prescription market due to extensive historical use, lower cost, and well-established production processes. Lithium citrate’s niche role limits its market share but offers opportunities for specialized applications.

  • Emerging Alternatives: Advances in mood-stabilizing medications—such as atypical antipsychotics and anticonvulsants—pose competition. Nonetheless, lithium’s unique efficacy in reducing suicidal risk sustains its importance.

Regulatory and Legal Factors

  • Stringent Monitoring and Packaging: Regulatory frameworks mandate strict plasma level monitoring and controlled dispensing, complicating widespread utilization but ensuring patient safety.

  • Patent and Intellectual Property Considerations: While lithium citrate itself is off-patent, formulation patents for delivery methods can influence market exclusivity for specific products.

Financial Trajectory and Market Forecast

Market Size and Revenue

  • Current Market Valuation: The global lithium-based psychiatric drugs market was valued at approximately USD 1.2 billion in 2022, with lithium carbonate accounting for the majority share. Lithium citrate, by comparison, is a smaller segment estimated at USD 100–150 million, mainly driven by institutional procurement.

  • Growth Projections: Compound annual growth rate (CAGR) forecasts for lithium-based psychiatric treatments are around 4-6% over the next five years. Lithium citrate's segment is expected to grow modestly, supported by increased psychiatric healthcare investments in emerging markets.

Pricing Trends

  • Cost Dynamics: Lithium citrate’s unit cost remains stable, but broader market factors such as raw material volatility and regulatory compliance costs influence pricing structures.

  • Reimbursement Landscape: Payers increasingly scrutinize lithium therapy costs, with reimbursement linked to clinical necessity and monitoring adherence; thus, pricing strategies are sensitive to healthcare policy changes.

Investment and R&D Outlook

  • Innovation Initiatives: R&D efforts aim to optimize lithium delivery, reduce toxicity, and develop alternative formulations. Patent extensions and novel drug delivery systems hold potential to enhance market exclusivity.

  • Market Penetration Strategies: Companies investing in targeted marketing, clinician education, and evidence dissemination are likely to expand lithium citrate’s utilization within approved indications.

Market Challenges and Risks

  • Toxicity and Safety Concerns: Lithium’s narrow therapeutic index necessitates ongoing monitoring, increasing treatment complexity.

  • Competition with Alternative Therapies: Efficacy of newer mood stabilizers and antipsychotics may limit lithium citrate’s residual market share.

  • Resource Limitations: Lithium supply constraints could lead to price volatility and manufacturing challenges, especially amid rising global demand.

  • Regulatory Hurdles: Changes in prescribing guidelines or safety regulations could impact availability and usage.

Future Outlook and Strategic Considerations

The outlook for lithium citrate hinges on ongoing clinical research validating its benefits over alternatives and innovation in delivery methods minimizing toxicity. Strategic partnerships focusing on R&D, supply chain resilience, and targeted markets can capitalize on emerging opportunities.

Market expansion into regions with underdiagnosed bipolar disorder, coupled with increasing mental health awareness, presents growth avenues despite the drug’s niche status. Additionally, integrating lithium’s neuroprotective properties into broader psychopharmacology paradigms could unlock further clinical applications.

Key Takeaways

  • The lithium citrate market remains niche yet vital within psychiatric therapeutics, buoyed by the global burden of bipolar disorder.

  • Demand is driven by increased diagnosis, clinical guidelines, and the unique anti-suicidal efficacy of lithium.

  • Supply chain stability is influenced by lithium resource constraints, with raw material availability affecting production and pricing.

  • Competitive pressures from newer medications limit lithium citrate’s growth but also emphasize the need for innovation, safety improvements, and targeted marketing.

  • The future trajectory relies heavily on ongoing research, regulatory frameworks, and strategic positioning within psychopharmacology.

FAQs

  1. What distinguishes lithium citrate from lithium carbonate in clinical use?
    Lithium citrate offers a more rapid onset of action and may be better tolerated in certain patients, although lithium carbonate remains the more widely prescribed form due to established manufacturing processes and cost considerations.

  2. Is lithium citrate more effective or safer than other lithium formulations?
    Clinical evidence suggests similar efficacy among lithium salts, with safety primarily contingent on proper monitoring rather than formulation differences. No definitive superiority has been conclusively established.

  3. How does lithium resource availability impact lithium citrate’s market?
    Limited lithium supplies can lead to price volatility and production constraints, directly influencing the cost and accessibility of lithium citrate.

  4. What future innovations could influence lithium citrate’s market?
    Development of alternative delivery systems reducing toxicity, personalized dosing algorithms, and novel formulations increasing patient compliance are potential catalysts for market growth.

  5. What are the key barriers to expanding lithium citrate usage globally?
    Stringent safety monitoring requirements, competition from newer medications, and raw material scarcity constrain broader adoption, especially in resource-limited settings.

References

[1] Geddes, J. R., & Miklowitz, D. J. (2013). Lithium: the classic mood stabilizer. Molecular Psychiatry, 18(9), 796–804.

[2] World Health Organization. (2018). Mental health: strengthening our response. WHO.

[3] Machado-Vieira, R., et al. (2017). Neuroprotective strategies and lithium's emerging role in neurodegenerative disease. Drug Discovery Today, 22(4), 728–735.

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