LITHIUM CARBONATE - Generic Drug Details

What are the generic drug sources for lithium carbonate and what is the scope of freedom to operate?

Lithium carbonate is the generic ingredient in seven branded drugs marketed by Noven Therap, Able, Alembic Ltd, Apotex Inc, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Hikma, Pharmobedient, Usl Pharma, Watson Labs, Solvay, Jds Pharms, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Unique, Ani Pharms, Bayer Pharms, Pfizer, and Sun Pharm Inds Inc, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for lithium carbonate. Twenty-one suppliers are listed for this compound.

Summary for LITHIUM CARBONATE

US Patents:	0
Tradenames:	7
Applicants:	21
NDAs:	36
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	105
Patent Applications:	6,834
Drug Prices:	Drug price trends for LITHIUM CARBONATE
What excipients (inactive ingredients) are in LITHIUM CARBONATE?	LITHIUM CARBONATE excipients list
DailyMed Link:	LITHIUM CARBONATE at DailyMed

See drug prices for LITHIUM CARBONATE

See drug sales revenues for LITHIUM CARBONATE

Recent Clinical Trials for LITHIUM CARBONATE

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

Sponsor	Phase
Centre Hospitalier Universitaire Dijon	PHASE1
Alzamend Neuro, Inc.	PHASE1
Massachusetts General Hospital	PHASE1

See all LITHIUM CARBONATE clinical trials

Pharmacology for LITHIUM CARBONATE

Drug Class

Mood Stabilizer

Medical Subject Heading (MeSH) Categories for LITHIUM CARBONATE

Antidepressive Agents

Antimanic Agents

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LITHIUM CARBONATE

N05AN	Lithium
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for LITHIUM CARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	LITHIUM CARBONATE	lithium carbonate	TABLET;ORAL	016834-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmobedient	LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	078763-001	Apr 15, 2008		DISCN	No	No
Hikma	LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	017812-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for LITHIUM CARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	LITHOBID	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	018027-001	Approved Prior to Jan 1, 1982	4,264,573

Market Dynamics and Financial Trajectory for Lithium Carbonate

Last updated: February 19, 2026

Lithium carbonate is a key raw material for manufacturing lithium-ion batteries and has applications in mental health therapeutics. The market's growth is driven by electric vehicle (EV) adoption, renewable energy storage, and pharmaceutical demand. The supply chain faces constraints from limited lithium resource extraction, environmental regulations, and geopolitical factors. Financially, the market shows significant capital investment, volatility in prices, and potential for high-margin sales.

Market Drivers

Electric Vehicle and Energy Storage Expansion

• EV sales increased from 2.5 million units in 2020 to over 10 million in 2022, with projected annual growth rates exceeding 20% through 2030 (International Energy Agency, 2022).
• Lithium-ion batteries dominate battery technology for EVs, accounting for roughly 70% of the market (BloombergNEF, 2021).
• The demand for lithium carbonate correlates directly with battery manufacturing expansion.

Pharmaceutical Sector Demand

• Lithium carbonate remains a primary treatment for bipolar disorder.
• Market size for psychiatric medications was valued at approximately USD 13 billion in 2021, with lithium representing around 30–40% of that (IQVIA, 2022).
• Growth depends on mental health awareness and prescription rates.

Supply Constraints

• Resource allocation for lithium extraction focuses chiefly on Australia, Chile, and China, which hold over 85% of global reserves (USGS, 2022).
• Production costs vary, influenced by environmental regulations, labor costs, and technological efficiencies.
• The lithium market exhibits lead times of over two years for new capacity to come online.

Price Trends and Volatility

Year	Price per Ton (USD)	Notes
2020	$5,000 - $6,000	Stable, pre-pandemic
2021	$12,000 - $14,000	Prices double due to supply shortages, increased demand
2022	$20,000 - $24,000	Market tightness persists, speculative behavior increases

• Prices doubled between 2020 and 2021, then more than doubled again in 2022.
• Price volatility remains high amid supply disruptions and demand surges.

Financial Outlook

Investment and Capital Flow

• Global lithium industry investments reached USD 3 billion in 2021, with projections to grow at 15–20% annually (Benchmark Mineral Intelligence, 2022).
• Major players include Albemarle, Ganfeng Lithium, and Livent, with capital expenditure primarily directed toward new mining projects and processing facilities.

Profit Margins

• Lithium carbonate producers report gross margins exceeding 40% due to high commodity prices.
• Downstream manufacturing companies benefit from economies of scale, but face input cost risks.

Market Risks

• Price corrections could occur if new project capacity exceeds demand.
• Regulatory developments regarding environmental sustainability could impact cost structures.
• Supply chain disruptions and geopolitical tensions threaten price stability.

Competitive Landscape

Company	Market Share (Estimated)	Production Capacity (Tonnes/year)	Notes
Albemarle	25%	80,000	Largest producer globally, based in the US
Ganfeng Lithium	15%	30,000	Chinese firm with expansion plans
Tianqi Lithium	12%	25,000	Australian-based, large reserves
Others	48%	Varies	Includes SQM, Livent, and new entrants

Capacity expansion and acquisitions are ongoing to meet projected surge in demand.

Policy and Geopolitical Factors

• Chile's environmental policies challenge lithium extraction, potentially limiting supply.
• Australia plans to expand capacity but faces regulatory and community objections.
• China supports domestic lithium industry through subsidies and infrastructural investments.

Future Outlook

Metric	2025 Projection	2030 Projection
Lithium carbonate price (USD/ton)	$25,000 - $30,000	$30,000 - $40,000
Lithium demand (Tons)	400,000–500,000	1,000,000+
Market valuation	USD 20–25 billion	USD 50–70 billion

The market is expected to double or triple in size driven by EV and energy storage needs. Development of new resources and processing methods may influence price stability.

Key Takeaways

• Lithium carbonate markets grow rapidly due to EV battery demand and pharmaceutical applications.
• Price volatility remains high, with prices jumping from USD 6,000 to over USD 24,000 per tonne between 2020 and 2022.
• Production capacity expansion faces environmental, regulatory, and geopolitical constraints.
• Major producers command significant market share, with ongoing investments to meet future demand.
• Price forecasts anticipate continued increase through 2030, risking oversupply if demand growth slows.

FAQs

Q1: What are the primary factors influencing lithium carbonate prices?
Prices are driven by supply-demand imbalances, extraction costs, technological advances, and geopolitical risks. Sudden supply shortages or surges in EV market growth cause significant fluctuations.

Q2: How sustainable is lithium extraction?
Environmental concerns restrict expansion options. Chile and Australia face mining regulation challenges; new technologies like direct lithium extraction aim to mitigate environmental impacts.

Q3: What role do government policies play?
Policies influence resource development, environmental standards, and subsidies for EV and energy storage. Chile’s environmental restrictions and Australian export policies are significant factors.

Q4: Who are the key players in lithium carbonate production?
Major companies include Albemarle, Ganfeng Lithium, Tianqi Lithium, SQM, and Livent. They control over 60% of global capacity.

Q5: What are the risks for investors in lithium carbonate markets?
Market risks include oversupply, price corrections, regulatory restrictions, and geopolitical instability. Highly volatile prices complicate investment planning.

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Citations

[1] International Energy Agency. (2022). Global EV Outlook 2022. Retrieved from https://www.iea.org/reports/global-ev-outlook-2022

[2] BloombergNEF. (2021). Battery Raw Materials Market Overview. Retrieved from https://about.bnef.com/blog/battery-raw-materials-market-set-for-rapid-growth

[3] IQVIA. (2022). Global Market for Psychotropic Medications. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/reports/psychiatric-meds

[4] US Geological Survey. (2022). Mineral Commodity Summaries 2022. Retrieved from https://pubs.usgs.gov/periodicals/mcs2022/mcs2022-lithium.pdf

[5] Benchmark Mineral Intelligence. (2022). Lithium Market Report. Retrieved from https://www.benchmarkminerals.com/research/