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Last Updated: December 26, 2024

LITHOBID Drug Patent Profile


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

Lithobid is a drug marketed by Ani Pharms and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Lithobid

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

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Summary for LITHOBID
Drug patent expirations by year for LITHOBID
Drug Prices for LITHOBID

See drug prices for LITHOBID

Recent Clinical Trials for LITHOBID

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

SponsorPhase
William V. Bobo, M.D.Phase 2
Alzheimer's Drug Discovery FoundationPhase 2
Johns Hopkins UniversityPhase 2

See all LITHOBID clinical trials

Pharmacology for LITHOBID
Drug ClassMood Stabilizer

US Patents and Regulatory Information for LITHOBID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms LITHOBID lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018027-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

LITHOBID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lithium in the Pharmaceutical Sector

Introduction to Lithium in Pharmaceuticals

Lithium, commonly known as Lithobid in its pharmaceutical form, is a crucial medication used primarily in the treatment of bipolar disorder, mania, and other mental health conditions. Here, we will delve into the market dynamics and financial trajectory of lithium in the pharmaceutical sector.

Global Lithium Drug Market Overview

The global lithium drug market is experiencing steady growth, driven by increasing cases of neurological disorders such as bipolar disorder, mania, and depression. Here are some key points:

Market Growth Rate

The global lithium drug market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.30% from 2021 to 2028[3].

Driving Factors

  • The rise in neurological diseases and disorders is a significant driver. Conditions such as bipolar disorder, mania, and depression are becoming more prevalent.
  • An increasing geriatric population, particularly those diagnosed with depression and other mood disorders, also contributes to market growth.
  • Growing awareness and healthcare expenditure in developing countries, especially in the Asia-Pacific region, are additional factors[3].

Geographical Market Share

North America

North America holds the largest market share due to a high prevalence of bipolar and depressive disorders, along with substantial healthcare expenditure and ongoing research and development[3].

Europe

Europe is the second-largest market, benefiting from refined medical facilities and a strong healthcare infrastructure[3].

Asia-Pacific

The Asia-Pacific region is expected to gain significant market share in the coming years due to advancements in technology, increasing healthcare expenditure, and rising awareness programs[3].

Patient Epidemiology Analysis

Disease Prevalence

The market growth is heavily influenced by the epidemiology of neurological diseases. For instance, the rising cases of depression in females in developing countries are a key factor[3].

Demographic Impact

Country demographics, including population growth and aging, play a crucial role in forecasting the market scenario. Disease epidemiology and import-export tariffs are also important considerations[3].

Challenges and Limitations

Strict Dose Monitoring

Lithium requires strict dose monitoring due to its narrow therapeutic index, which can be a challenge for both patients and healthcare providers[3].

Alternative Medications

The presence of alternative medications and organic products can hamper the growth of the lithium drug market. Adverse drug reactions related to lithium usage are another significant concern[3].

Financial Performance and Cost Considerations

Production Costs

While the pharmaceutical aspect of lithium does not directly involve mining and refining costs, the overall cost of production and distribution can impact the financial trajectory. For example, in the broader lithium market, companies like Sigma Lithium have achieved low production costs through increased throughput and expense discipline, which can indirectly influence the pharmaceutical sector by affecting raw material costs[5].

Revenue and Profit Margins

The financial performance of companies involved in the lithium drug market can vary. However, the overall trend suggests that with growing demand, companies can achieve significant revenue and profit margins. For instance, the broader lithium market has seen companies like Sigma Lithium generate substantial adjusted EBITDA and free cash flow despite fluctuations in lithium prices[5].

Market Trends and Future Outlook

Increasing Demand

The demand for lithium in the pharmaceutical sector is expected to continue growing due to the increasing prevalence of neurological disorders. This trend is likely to be sustained by advancements in healthcare and rising awareness about mental health conditions[3].

Regulatory and Competitive Landscape

The market is influenced by regulatory changes and the presence of global and local brands. The competition from alternative medications and the impact of sales channels are critical factors in forecasting the future market scenario[3].

Geopolitical and Supply Chain Risks

While the pharmaceutical sector is less directly affected by geopolitical risks compared to the industrial lithium market, any disruptions in the supply chain can have cascading effects. For instance, China's dominance in the global refining capacity of lithium could impact the availability and cost of raw materials for pharmaceutical applications[4].

Conclusion

The lithium drug market, driven by the increasing prevalence of neurological disorders, is poised for steady growth. However, it faces challenges such as strict dose monitoring, alternative medications, and potential supply chain disruptions.

Key Takeaways

  • The global lithium drug market is growing at a CAGR of 4.30% from 2021 to 2028.
  • North America and Europe are the largest markets, with the Asia-Pacific region expected to grow significantly.
  • Strict dose monitoring and the presence of alternative medications are key challenges.
  • The market is influenced by disease epidemiology, demographic changes, and regulatory factors.
  • Supply chain risks, though less direct, can impact the pharmaceutical sector.

FAQs

1. What is the primary use of lithium in the pharmaceutical sector?

Lithium is primarily used in the treatment of bipolar disorder, mania, and other mental health conditions.

2. What is the projected growth rate of the global lithium drug market?

The global lithium drug market is projected to grow at a CAGR of 4.30% from 2021 to 2028.

3. Which region holds the largest market share for lithium drugs?

North America holds the largest market share due to a high prevalence of bipolar and depressive disorders and substantial healthcare expenditure.

4. What are the main challenges facing the lithium drug market?

The main challenges include strict dose monitoring, the presence of alternative medications, and potential adverse drug reactions.

5. How does the broader lithium market impact the pharmaceutical sector?

The broader lithium market can impact the pharmaceutical sector through raw material costs and supply chain disruptions, although these effects are generally indirect.

Cited Sources:

  1. Wood Mackenzie - Six factors shaping the lithium market
  2. Sigma Lithium Resources - Sigma Lithium announces final investment decision and initiation of construction to double production capacity
  3. Data Bridge Market Research - Global Lithium Drug Market - Industry Trends and Forecast to 2028
  4. Semantic Visions - Lithium Market Trends: Supply Chain Risks and Growth Opportunities
  5. PR Newswire - Sigma Lithium announces final investment decision and initiation of construction to double production capacity to 520,000t/y

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