Last Updated: June 17, 2026

LITHONATE Drug Patent Profile


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When do Lithonate patents expire, and when can generic versions of Lithonate launch?

Lithonate is a drug marketed by Solvay and is included in two NDAs.

The generic ingredient in LITHONATE is lithium citrate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lithonate

A generic version of LITHONATE was approved as lithium citrate by PAI HOLDINGS PHARM on May 21st, 1986.

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Summary for LITHONATE
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for LITHONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay LITHONATE lithium carbonate CAPSULE;ORAL 016782-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay LITHONATE lithium citrate SYRUP;ORAL 017672-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Lithonate (Lithium Carbonate) Investment and Fundamentals Analysis

Last updated: March 4, 2026

What is Lithonate and its Market Context?

Lithonate is a brand name for lithium carbonate, primarily prescribed for bipolar disorder management. It is a well-established pharmacological treatment with over five decades of use. The compound functions as a mood stabilizer, with a global market estimated at approximately $600 million in 2022, expected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% through 2027 [1].

Key Financial and Market Indicators

Indicator Value / Status Source
Global Market Size (2022) $600 million [1]
CAGR (2022–2027) 4.5% [1]
Leading Market Players GlaxoSmithKline (GSK), Tarkett, Others Company financial reports, market research reports[2]
Patent Status Off-patent since early 2000s Patent expiry facilitates generic manufacturing [3]

Market Drivers and Growth Factors

  1. Prevalence of Bipolar Disorder: Affects approximately 1-2% of the global population, driving consistent demand for lithium therapy [4].

  2. Generic Competition: Patent expiry has increased the supply of low-cost lithium carbonate, suppressing prices but expanding market volume globally.

  3. Rising Mental Health Awareness: Increased diagnosis and treatment of mood disorders bolster overall lithium demand.

  4. Limited New Entrants: Lithium carbonate has a well-established safety profile, deterring new drug development that could replace it.

Key Investment Considerations

Supply Chain and Raw Material Prices

Lithium carbonate relies on lithium extraction, with prices fluctuating based on supply-demand dynamics. Price spikes in 2018 and 2021–2022 doubled raw material costs, impacting profit margins for manufacturers [5]. Long-term supply contracts mitigate volatility risks for established companies.

Regulatory Environment

No recent regulatory hurdles surfaced for lithium carbonate; its long market presence provides stability. However, environmental regulations on lithium mining may influence future supply costs [6].

Competitive Landscape

Market is highly commoditized with multiple generic producers. GSK’s original patent expired in 2003, leading to a prolific generic market. Leading global producers include Albemarle Corporation and Ganfeng Lithium. Competitive pricing pressures constrain profit margins but support volume growth.

R&D Outlook

Limited R&D for lithium carbonate itself; focus shifts to new formulations or combination therapies for bipolar disorder. Some research seeks to develop safer formulations with fewer side effects but remains experimental.

Financial Outlook and Investment Risks

  • Revenue Trends: Stable worldwide demand supports steady revenues in the near term.
  • Margins: Thin margins due to generic competition; profitability depends on operational efficiency and raw material costs.
  • Growth Potential: Limited expansion opportunities; growth hinges on increasing diagnosis rates and expanding access in emerging markets.
  • Risks:
    • Supply disruptions from lithium resource constraints.
    • Regulatory and environmental policies affecting production costs.
    • Potential development of new bipolar disorder therapies, threatening market share.

Recent Market Developments

  • Price Increases: Lithium carbonate prices surged by 100% in 2021–2022 due to supply shortages; subsequent stabilization observed [7].
  • Environmental Regulations: Lithium mining faces stricter environmental scrutiny in Australia and South America, where most reserves are located, possibly raising future costs [6].

Investment Summary

Lithonate’s market stability derives from its pivotal role in bipolar disorder treatment and the absence of significant near-term patent protection. The market's commoditized nature results in stable revenue streams but compressed profit margins. Long-term supply chain challenges and environmental policies pose risks, balanced against increasing global mental health awareness and rising diagnosis rates.

Key Takeaways

  • Lithium carbonate remains a stable, essential bipolar disorder treatment.
  • The global market is mature with moderate growth prospects driven by increased mental health awareness.
  • Price volatility in raw materials presents supply risks, but established producers have mitigated this.
  • Limited R&D reduces innovation risk but caps future growth.
  • Regulatory and environmental factors could influence supply costs.

Frequently Asked Questions

1. Is Lithonate a good investment?
Investment suitability depends on exposure to lithium supply chains and market stability. It offers steady revenues but limited growth due to market saturation.

2. What are the main competitors?
Generic producers like Albemarle Corporation and Ganfeng Lithium dominate the supply chain, with no significant branded competitors since patent expiration.

3. How does lithium price volatility affect Lithonate?
Price swings in raw materials directly impact manufacturing costs, but long-term contracts and bulk procurement mitigate short-term effects.

4. Are there emerging alternatives to lithium carbonate?
Yes, research explores novel mood stabilizers and therapies. None currently threaten lithium’s market position significantly.

5. What regulatory risks are associated with lithium carbonate?
While current regulations are stable, future environmental policies in lithium-producing regions could raise extraction and manufacturing costs.


References

[1] MarketWatch. (2022). Lithium market analysis and forecasts.

[2] Company financial reports. (2022). Industry market share and performance data.

[3] U.S. Patent Office. (2002). Patent statuses for lithium carbonate formulations.

[4] World Federation of Mental Health. (2020). Global prevalence of bipolar disorder.

[5] Benchmark Mineral Intelligence. (2022). Lithium raw materials and pricing trends.

[6] Environmental regulation reports. (2022). Lithium mining impacts and policies.

[7] Financial Times. (2022). Lithium prices surge and market implications.

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