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Last Updated: March 14, 2025

LITHANE Drug Patent Profile


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Which patents cover Lithane, and what generic alternatives are available?

Lithane is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in LITHANE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lithane

A generic version of LITHANE was approved as lithium carbonate by HIKMA on January 29th, 1982.

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Summary for LITHANE
Drug patent expirations by year for LITHANE
Recent Clinical Trials for LITHANE

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

SponsorPhase
William V. Bobo, M.D.Phase 2
Nova Scotia Health AuthorityPhase 3
Fred Hutchinson Cancer Research CenterN/A

See all LITHANE clinical trials

US Patents and Regulatory Information for LITHANE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bayer Pharms LITHANE lithium carbonate TABLET;ORAL 018833-001 Jul 18, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Pharmaceutical Grade Lithium Carbonate Market: Dynamics and Financial Trajectory

Market Overview

The pharmaceutical grade lithium carbonate market is driven by several key factors, primarily centered around the increasing prevalence of mental health disorders and the critical role lithium plays in their treatment.

Drivers: Rising Cases of Mental Illness

One of the primary drivers of the pharmaceutical grade lithium carbonate market is the rising number of mental health conditions. The growing awareness of mental health, changes in lifestyle, and increased stress levels have contributed significantly to this trend. In the United States alone, more than one in five individuals (approximately 57.8 million in 2021) live with a mental disease, driving the demand for mood stabilizers like lithium carbonate[1].

Historical Context and Approval

Lithium has a long history in psychiatric treatment. It was first prescribed for mania in 1871 by William A. Hammond, and its modern use was solidified by John Cade’s accidental discovery of its calming properties in 1947. The US FDA approved lithium for the treatment of bipolar disorder in 1970, and it remains a gold standard for managing bipolar disorder to this day[2].

Regional Market Dynamics

North America

North America is projected to hold the largest market share in the pharmaceutical grade lithium carbonate market. This region is home to leading research institutions and governments that have introduced policies to increase access to mental health care, raise public awareness, and promote research. The high prevalence of mood disorders and advanced healthcare infrastructure in the US and Canada further fuel the market growth[1][4].

Asia Pacific

The Asia Pacific region is expected to grow significantly during the forecast period. Countries like China, India, and Japan are experiencing rapid growth in the pharmaceutical industry, driven by increasing mental health awareness and the prevalence of mood disorders[4].

Europe, Middle East & Africa, and South America

Other regions, including Europe, the Middle East & Africa, and South America, also contribute to the market growth. In Europe, countries like Germany, France, and the UK have well-established healthcare systems and growing cases of mental illness, driving demand. In the Middle East & Africa and South America, growing awareness and government support for mental health issues are key drivers[1].

Market Size and Financial Projections

  • The global pharmaceutical grade lithium carbonate market was valued at USD 141 million in 2023 and is projected to reach USD 166 million by 2028, growing at a CAGR of 3.3% from 2023 to 2028[1].
  • Another forecast indicates that the market size is expected to exceed USD 175 million by 2032, growing at a CAGR of 3.1% from 2022 to 2032[4].

Key Players and Market Share

The market is dominated by several key players, including Livent Corporation, Albemarle Corporation, Jiangsu Lianhuan Pharmaceutical Co., Ltd., American Elements, and others. These companies play a crucial role in the production, distribution, and innovation of pharmaceutical grade lithium carbonate[1][4].

Value Chain Analysis

The value chain of pharmaceutical grade lithium carbonate involves several stages:

  • Lithium Resource Extraction and Processing: The initial step involves extracting lithium from natural sources.
  • Conversion to Lithium Carbonate: The extracted lithium is then converted into lithium carbonate.
  • Purification and Quality Control: Ensuring the purity of lithium carbonate is critical for pharmaceutical use.
  • Pharmaceutical Formulation and Manufacturing: The purified lithium carbonate is formulated into pharmaceutical products.
  • Regulatory Compliance and Testing: Adherence to stringent pharmaceutical standards and regulations is essential.
  • Distribution and Supply Chain: Efficient distribution and supply chain management are vital for market penetration[1].

Regulatory Landscape

The pharmaceutical grade lithium carbonate market is heavily regulated. Regulatory bodies, government agencies, and other organizations ensure compliance with strict standards to guarantee the safety and efficacy of the product. This regulatory environment presents both challenges and opportunities for market players[1].

Opportunities and Challenges

Opportunities

  • Potential for New Applications: Ongoing clinical research and innovation could lead to new applications of lithium carbonate, expanding its market potential.
  • Growing Awareness and Government Support: Increasing awareness of mental health issues and government initiatives to support mental health care are driving the market forward[1].

Challenges

  • Availability of Substitutes: The presence of alternative mood stabilizers can pose a challenge to the market.
  • Side Effects and Safety Concerns: Lithium has a narrow therapeutic index, and its use is associated with serious side effects such as renal, thyroid, and cardiac issues, which require careful monitoring[1][2].
  • Stringent Pharmaceutical Standards and Regulations: Adhering to strict regulatory requirements can be challenging.
  • Stigma and Perception of Mental Disorders: The stigma associated with mental health issues can affect market growth and patient compliance[1].

Clinical and Therapeutic Benefits

Lithium is a potent mood stabilizer with significant benefits in managing bipolar disorder and other mood disorders. It has preventative effects against suicide, reduces aggression and impulsivity, and has neuroprotective properties that may be beneficial in treating conditions like Alzheimer's disease[2].

Future Outlook

The market for pharmaceutical grade lithium carbonate is poised for steady growth driven by increasing mental health awareness, advancements in clinical research, and government support. However, addressing the challenges related to side effects, regulatory compliance, and stigma will be crucial for sustained market expansion.

Key Takeaways

  • The pharmaceutical grade lithium carbonate market is driven by the rising cases of mental illness and growing awareness of mental health.
  • North America is expected to hold the largest market share, followed by significant growth in the Asia Pacific region.
  • The market is projected to reach USD 166 million by 2028 and USD 175 million by 2032.
  • Key players include Livent Corporation, Albemarle Corporation, and Jiangsu Lianhuan Pharmaceutical Co., Ltd.
  • The market faces challenges such as side effects, regulatory compliance, and stigma associated with mental health issues.

FAQs

Q: What is the primary driver of the pharmaceutical grade lithium carbonate market?

The primary driver is the increasing number of mental health conditions, particularly mood disorders, and the growing awareness of mental health issues.

Q: Which region is expected to hold the largest market share in the pharmaceutical grade lithium carbonate market?

North America is projected to hold the largest market share due to its well-established healthcare system and high prevalence of mood disorders.

Q: What are the potential new applications of lithium carbonate?

Ongoing clinical research and innovation could lead to new applications of lithium carbonate, including its potential use in treating conditions like Alzheimer's disease.

Q: What are the major challenges faced by the pharmaceutical grade lithium carbonate market?

The market faces challenges such as the availability of substitutes, side effects and safety concerns, stringent pharmaceutical standards and regulations, and the stigma associated with mental disorders.

Q: How does lithium carbonate impact suicide rates in patients with mood disorders?

Lithium therapy significantly lowers the number of both attempted and completed suicides by reducing aggression, impulsivity, and the number of mood disorder relapses.

Sources

  1. MarketsandMarkets: Pharmaceutical Grade Lithium Carbonate Market - MarketsandMarkets
  2. Psychiatric Times: Lithium: Past, Present, and Future - Psychiatric Times
  3. Frontiers in Medicine: Commercial and business aspects of alpha radioligand therapeutics
  4. Spherical Insights: Pharmaceutical Grade Lithium Carbonate Market Size, 2032

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