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Last Updated: December 22, 2024

ESKALITH Drug Patent Profile


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When do Eskalith patents expire, and what generic alternatives are available?

Eskalith is a drug marketed by Noven Therap and Jds Pharms and is included in three NDAs.

The generic ingredient in ESKALITH 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 Eskalith

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

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

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

SponsorPhase
Centre for Addiction and Mental HealthPhase 4
Washington University School of MedicinePhase 4
Patient-Centered Outcomes Research InstitutePhase 4

See all ESKALITH clinical trials

US Patents and Regulatory Information for ESKALITH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven Therap ESKALITH lithium carbonate CAPSULE;ORAL 016860-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jds Pharms ESKALITH lithium carbonate TABLET;ORAL 017971-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jds Pharms ESKALITH CR lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018152-001 Mar 29, 1982 DISCN No No ⤷  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

ESKALITH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESKALITH (Lithium Carbonate)

Introduction to ESKALITH

ESKALITH, a brand name for lithium carbonate, is a medication primarily used to treat bipolar disorder. It works by balancing the substances in the brain that help regulate mood, behaviors, and thoughts[3,.

Market Segmentation and Growth Drivers

Disorders Treated

The lithium drug market, which includes ESKALITH, is segmented by disorders such as bipolar disorder, depression, schizophrenia, mania, and attention-deficit hyperactivity disorder (ADHD). Bipolar disorder, particularly, is a significant segment, further divided into type 1 and type 2[1].

Market Growth

The global lithium drug market, including ESKALITH, is expected to grow at a CAGR of 4.30% from 2021 to 2028. This growth is driven by the increasing prevalence of neurological diseases and disorders, such as bipolar disorder and depression. The rising geriatric population and cases of depression in females in developing countries also contribute to this growth[1].

Drug Type and Dosage

Branded vs. Generic

The market is segmented into branded and generic drugs. ESKALITH is a branded drug, which, along with other branded lithium drugs like Lithobid, holds a significant market share. However, generic versions are also available and compete in the market[1].

Dosage Forms

ESKALITH is available in various dosage forms, including immediate-release capsules and controlled-release tablets. The controlled-release tablets are designed to reduce the variability in lithium blood levels, providing a more stable therapeutic effect[4].

End-Users and Distribution Channels

End-Users

The primary end-users of ESKALITH include hospitals, specialty clinics, and home healthcare services. These settings ensure the medication is administered under medical supervision, which is crucial due to the narrow therapeutic index of lithium[1].

Distribution Channels

The distribution channels for ESKALITH include direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and others. The availability through multiple channels ensures widespread access to the medication[1].

Geographical Analysis

Regional Market Share

North America holds the largest market share for lithium drugs, including ESKALITH, due to a high prevalence of bipolar and depressive disorders, significant healthcare expenditure, and robust research and development activities. Europe is the second-largest market, while Asia-Pacific is expected to grow significantly due to increasing healthcare expenditure and technological advancements[1].

Financial Performance and Trajectory

Revenue and Market Size

The global lithium drug market is expected to see substantial growth, driven by increasing demand and expanding patient populations. While specific revenue figures for ESKALITH are not isolated, the overall market growth indicates a positive financial trajectory for branded lithium drugs[1].

Cost and Pricing

The cost of producing lithium, including for ESKALITH, is influenced by factors such as raw material costs, production efficiency, and market demand. Companies like Sigma Lithium, which produce lithium, have reported low production costs and significant financial margins. For instance, Sigma Lithium achieved an adjusted EBITDA of $49.1 million in 2023, reflecting a margin of 36.4%, despite a decline in lithium prices[2].

Operational Efficiency and Cost Management

Production Costs

Efficient production and cost management are critical for maintaining profitability. Sigma Lithium, for example, has guided unit cash operating costs to be $420/tonne for the third quarter of 2024, highlighting the importance of cost discipline in the lithium industry[2].

Financial Margins

The ability to generate free cash flow (FCF) is a key indicator of financial health. Sigma Lithium generated $29 million of FCF in the fourth quarter of 2023, demonstrating the financial stability and operational efficiency of lithium producers[2].

Challenges and Risks

Regulatory and Safety Concerns

Lithium therapy, including ESKALITH, comes with strict monitoring requirements due to the risk of lithium toxicity. This necessitates regular serum lithium level checks and careful dosage adjustments, which can be a challenge in some healthcare settings[4].

Alternative Medications and Adverse Reactions

The presence of alternative medications and the potential for adverse drug reactions can hamper the market growth of ESKALITH. However, its established efficacy in treating bipolar disorder and other mental health conditions helps maintain its market position[1].

Key Takeaways

  • Market Growth: The global lithium drug market, including ESKALITH, is growing at a CAGR of 4.30% driven by increasing neurological disorders.
  • Segmentation: The market is segmented by disorders, drug type, dosage, end-users, and distribution channels.
  • Geographical Presence: North America and Europe are significant markets, with Asia-Pacific expected to grow substantially.
  • Financial Performance: Efficient production and cost management are crucial for maintaining profitability, as seen in companies like Sigma Lithium.
  • Challenges: Strict monitoring and potential adverse reactions are key challenges.

FAQs

1. What is ESKALITH used for? ESKALITH (lithium carbonate) is primarily used to treat bipolar disorder, helping to balance substances in the brain that regulate mood, behaviors, and thoughts[3].

2. What are the different dosage forms of ESKALITH? ESKALITH is available in immediate-release capsules and controlled-release tablets, designed to reduce variability in lithium blood levels[4].

3. What are the key drivers of the lithium drug market? The market is driven by the increasing prevalence of neurological diseases, a rising geriatric population, and growing healthcare expenditure[1].

4. How does the geographical distribution of the lithium drug market look? North America holds the largest market share, followed by Europe, with Asia-Pacific expected to grow significantly in the coming years[1].

5. What are the financial challenges faced by lithium drug producers like ESKALITH? Producers face challenges such as strict dose monitoring, alternative medications, and potential adverse drug reactions, which can impact market growth and profitability[1].

Cited Sources

  1. Data Bridge Market Research: Global Lithium Drug Market - Industry Trends and Forecast to 2028.
  2. Sigma Lithium Resources: Sigma Lithium Announces Final Investment Decision and Initiation of Construction.
  3. Cleveland Clinic: Lithium (Eskalith): Uses & Side Effects.
  4. FDA: ESKALITH (lithium carbonate) Capsules, 300 mg ESKALITH CR (lithium carbonate) Controlled-Release Tablets, 450 mg.
  5. PR Newswire: Sigma Lithium Announces Filing Technical Report with Outstanding Economic Results.

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