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Last Updated: March 14, 2025

EPITOL Drug Patent Profile


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Which patents cover Epitol, and when can generic versions of Epitol launch?

Epitol is a drug marketed by Teva and is included in two NDAs.

The generic ingredient in EPITOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epitol

A generic version of EPITOL was approved as carbamazepine by TARO on October 3rd, 1996.

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Drug patent expirations by year for EPITOL
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Drug Sales Revenue Trends for EPITOL

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US Patents and Regulatory Information for EPITOL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva EPITOL carbamazepine TABLET;ORAL 070541-001 Sep 17, 1986 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524-001 Jul 29, 1992 AB RX 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 2 of 2 entries

Market Dynamics and Financial Trajectory for Epitol (Carbamazepine)

Introduction to Epitol (Carbamazepine)

Epitol, known generically as carbamazepine, is a versatile anticonvulsant and analgesic drug used in the treatment of various neurological and psychiatric conditions. It is marketed under several brand names, including Carbatrol, Tegretol, and Equetro[1].

Indications and Usage

Epitol is primarily indicated for the treatment of epilepsy, particularly for partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizure patterns. It is also used for trigeminal neuralgia, bipolar disorder, and other neuropathic pain conditions[4].

Market Overview

The global carbamazepine market, which includes Epitol, is expected to experience healthy growth driven by increasing demand for treatments of epilepsy, bipolar disorders, and other neurological conditions. The market is influenced by several key factors:

Epilepsy Market Growth

The dynamic growth of the epilepsy market, especially among the mid-teen age group, presents significant opportunities for carbamazepine. The increasing number of cases and the need for effective treatments are driving the demand for Epitol and other carbamazepine formulations[1].

Expanding Therapeutic Uses

Carbamazepine's therapeutic applications extend beyond epilepsy to include bipolar disorders, trigeminal neuralgia, and various neuropathic pain conditions. This broad spectrum of uses contributes to the drug's market growth[1].

Market Trends and Opportunities

Several trends and opportunities are shaping the market for Epitol:

FDA Approvals and Formulations

The FDA approval of controlled-release formulations of carbamazepine, such as Carnexiv for intravenous use, has expanded the treatment options for patients who cannot take oral forms due to certain conditions. This has positively impacted the market by providing alternative treatment avenues[1].

Increasing Prevalence of Target Conditions

The rising prevalence of epilepsy, bipolar disorders, and other conditions for which carbamazepine is prescribed is a significant driver of market growth. For instance, the use of newer therapies for epilepsy and bipolar depression has seen a substantial increase in recent years[1].

Challenges and Risks

Despite the positive trends, the market for Epitol faces several challenges:

Side Effects and Safety Concerns

Carbamazepine is associated with severe side effects such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), agranulocytosis, and aplastic anemia. These risks can hinder market growth and necessitate careful patient monitoring[1].

Regulatory and Pricing Pressures

Changes in regulatory policies and pricing pressures, such as those seen in the Medicare Drug Price Negotiation Program, can impact the financial trajectory of pharmaceuticals. While these programs aim to reduce drug costs, they can also affect the revenue streams of pharmaceutical companies[2].

Financial Trajectory

The financial performance of Epitol and the broader carbamazepine market is influenced by several factors:

Revenue Growth

The market for carbamazepine is expected to expand at a healthy growth rate due to increasing demand and the introduction of new formulations. The global carbamazepine market has seen significant revenue growth, driven by the expanding therapeutic uses and increasing prevalence of target conditions[1].

Competitive Landscape

The market is competitive, with several key vendors operating in the space. Companies such as Novartis, Janssen, and others are profiled in market reports, highlighting their product portfolios, financial standings, and recent developments. This competitive landscape can impact pricing and market share[1].

Pricing and Cost Savings

Initiatives like the Medicare Drug Price Negotiation Program aim to reduce drug costs, which can impact the revenue of pharmaceutical companies. However, these programs also lead to cost savings for patients and healthcare systems, potentially increasing access to treatments like Epitol[2].

Vendor Landscape and Competitive Analysis

The vendor landscape for the global carbamazepine market includes a detailed analysis of key vendors. This analysis covers their product specifications, financial standing, and recent developments. It also includes a SWOT analysis to highlight the strengths, weaknesses, opportunities, and threats faced by these vendors during the forecast period[1].

Expert Insights and Recommendations

Industry experts recommend that new and existing players in the market focus on developing safer and more effective formulations, expanding their product portfolios, and navigating regulatory changes effectively. These strategies can help companies maintain a competitive edge in the market[1].

Recent Developments and Future Outlook

Recent developments, such as the approval of new formulations and the expansion of therapeutic uses, are expected to continue driving the market. However, the market must also address the challenges posed by side effects and regulatory pressures to sustain long-term growth.

"The dynamic growth of the epilepsy market with the increasing number of cases in the mid-teen age group is presenting lucrative growth opportunities to the carbamazepine market."[1]

Key Takeaways

  • Growing Demand: The market for Epitol is driven by increasing demand for treatments of epilepsy, bipolar disorders, and other neurological conditions.
  • Expanding Therapeutic Uses: Carbamazepine's broad spectrum of therapeutic applications contributes to its market growth.
  • Challenges: The market faces challenges such as severe side effects and regulatory pricing pressures.
  • Financial Trajectory: The market is expected to experience healthy revenue growth despite these challenges.
  • Competitive Landscape: The market is competitive, with key vendors focusing on product development and regulatory compliance.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for Epitol (carbamazepine)? A: Epitol is primarily indicated for the treatment of epilepsy, particularly partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizure patterns. It is also used for trigeminal neuralgia and bipolar disorder[4].

Q: What are the potential side effects of carbamazepine? A: Carbamazepine is associated with severe side effects such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), agranulocytosis, and aplastic anemia[1].

Q: How does the FDA approval of new formulations impact the market? A: The FDA approval of new formulations, such as Carnexiv for intravenous use, expands treatment options and positively impacts the market by providing alternative treatment avenues[1].

Q: What are the key drivers of the carbamazepine market growth? A: The market growth is driven by the increasing demand for treatments of epilepsy, bipolar disorders, and other neurological conditions, as well as the expanding therapeutic uses of carbamazepine[1].

Q: How do regulatory pricing pressures affect the financial trajectory of Epitol? A: Regulatory pricing pressures, such as those from the Medicare Drug Price Negotiation Program, can reduce revenue for pharmaceutical companies but also lead to cost savings for patients and healthcare systems[2].

Sources:

  1. Biospace: "Carbamazepine Market is expected to expand at a healthy growth rate by 2025: TMR Research Study" - https://www.biospace.com/carbamazepine-market-is-expected-to-expand-at-a-healthy-growth-rate-by-2025-tmr-research-study
  2. CMS: "Medicare Drug Price Negotiation Program" - https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf
  3. Drugs.com: "Epitol: Package Insert / Prescribing Information" - https://www.drugs.com/pro/epitol.html

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