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Last Updated: December 22, 2024

OXCARBAZEPINE Drug Patent Profile


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

Oxcarbazepine is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus. and is included in twenty-five NDAs.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oxcarbazepine

A generic version of OXCARBAZEPINE was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.

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

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Recent Clinical Trials for OXCARBAZEPINE

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

SponsorPhase
Dr Cipto Mangunkusumo General HospitalPhase 4
Wayne State UniversityPhase 4
Postgraduate Institute of Dental Sciences RohtakPhase 4

See all OXCARBAZEPINE clinical trials

Pharmacology for OXCARBAZEPINE
Anatomical Therapeutic Chemical (ATC) Classes for OXCARBAZEPINE
Paragraph IV (Patent) Challenges for OXCARBAZEPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OXTELLAR XR Extended-release Tablets oxcarbazepine 150 mg and 300 mg 202810 1 2013-04-12
OXTELLAR XR Extended-release Tablets oxcarbazepine 600 mg 202810 1 2013-03-20
TRILEPTAL Oral Suspension oxcarbazepine 300 mg/5 mL 021285 1 2006-12-26
TRILEPTAL Tablets oxcarbazepine 150 mg, 300 mg and 600 mg 021014 1 2006-05-05

US Patents and Regulatory Information for OXCARBAZEPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rubicon OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077747-003 Apr 9, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077795-002 Oct 9, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus OXCARBAZEPINE oxcarbazepine TABLET;ORAL 211747-001 Jul 3, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794-003 Oct 9, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus OXCARBAZEPINE oxcarbazepine TABLET;ORAL 211747-002 Jul 3, 2023 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

OXCARBAZEPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxcarbazepine

Introduction to Oxcarbazepine

Oxcarbazepine is an antiepileptic medication primarily used to treat partial seizures and, in some cases, bipolar disorder. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth Projections

The oxcarbazepine market is experiencing significant growth. As of 2023, the market size was valued at USD 436 million and is projected to reach USD 630.9 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.8% from 2024 to 2030[1].

Key Drivers of Market Growth

Growing Epilepsy Prevalence

The increasing incidence of epilepsy worldwide is a major driver for the demand of oxcarbazepine. As more people are diagnosed with epilepsy, the need for effective anticonvulsant medications like oxcarbazepine rises[1].

Increasing Awareness and Diagnosis

Greater awareness and improved diagnostic techniques lead to more people seeking treatment for epilepsy and other conditions treated by oxcarbazepine, thereby increasing market demand[1].

Developments in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing nations, enhance access to diagnosis and treatment, contributing to market expansion[1].

Growing Geriatric Population

The aging global population increases the susceptibility to diseases like epilepsy, which in turn boosts the demand for oxcarbazepine[1].

Government Financing and Efforts

Government initiatives and financing for epilepsy treatment and awareness campaigns play a significant role in increasing access to care and driving market growth[1].

Market Segmentation

By Type

Oxcarbazepine is available in various forms, including tablets, oral suspension, and injectables. Tablets are the most common form, while oral suspension is preferred for children or those with difficulty swallowing tablets. Injectables are less common but used in specific medical settings[1].

By Application

The primary application of oxcarbazepine is in the treatment of epilepsy, including partial seizures. It is also used off-label for bipolar disorder to stabilize mood swings[1].

By Geography

The market is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are significant markets due to high prevalence rates, while the Asia Pacific region is growing due to increasing awareness and improving healthcare infrastructure[1].

Challenges and Restraints

Regulatory Obstacles

Tight regulations, especially in key markets, can hinder market entry and growth. Changes in regulatory environments can impact the dynamics of the oxcarbazepine market[1].

Side Effects and Safety Issues

Reports of serious side effects or safety issues can reduce acceptance and lead to regulatory actions, affecting market growth[1].

Alternative Therapies

The availability of alternative antiepileptic medications can limit the market expansion of oxcarbazepine[1].

Restricted Therapeutic Applications

Oxcarbazepine’s market potential is limited if it is approved for only a few indications compared to medications with broader therapeutic applications[1].

Market Saturation

In developed markets where oxcarbazepine has already gained widespread acceptance, market saturation can limit further expansion[1].

Price Sensitivity

Price competition, especially in areas with restricted healthcare reimbursement, can affect market growth and profitability[1].

Technological Advancements and Innovations

Extended-Release Formulations

The development of extended-release formulations, such as Oxcarbazepine XR, enhances compliance and reduces adverse effects associated with peak concentrations (Cmax). This innovation, though not groundbreaking, offers significant benefits by improving the delivery mode[2].

Research and Development

Continued advancements in the treatment of epilepsy may lead to new formulations or applications for oxcarbazepine, further growing the market[1].

Financial Implications

Revenue Projections

The projected growth to USD 630.9 million by 2030 indicates a robust financial trajectory for the oxcarbazepine market. This growth is driven by increasing demand and expanding market segments[1].

Competitor Analysis

The market is competitive, with multiple players, including generic manufacturers. The expiration of patents can lead to more generic versions entering the market, which may impact the market share and profitability of original manufacturers[1].

Regional Market Performance

North America is one of the prominent consumers of oxcarbazepine, followed by Europe and the Asia Pacific region. The regional performance is influenced by factors such as prevalence rates, healthcare infrastructure, and regulatory environments[1][4].

Impact of Generic Versions

The introduction of generic versions of oxcarbazepine has made the medication more accessible and affordable, contributing to market expansion. However, this also poses a challenge to original manufacturers as it can reduce their market share and profitability[1].

Conclusion

The oxcarbazepine market is poised for significant growth driven by increasing epilepsy prevalence, improving healthcare infrastructure, and government initiatives. While challenges such as regulatory obstacles, side effects, and alternative therapies exist, innovations like extended-release formulations and ongoing research and development are expected to drive the market forward.

Key Takeaways

  • The oxcarbazepine market is projected to grow from USD 436 million in 2023 to USD 630.9 million by 2030.
  • Key drivers include growing epilepsy prevalence, increasing awareness and diagnosis, and improvements in healthcare infrastructure.
  • The market is segmented by type (tablets, oral suspension, injectables), application (epilepsy, bipolar disorder), and geography (North America, Europe, Asia Pacific, etc.).
  • Challenges include regulatory obstacles, side effects, alternative therapies, and market saturation.
  • Innovations such as extended-release formulations are enhancing market growth.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the oxcarbazepine market?

The oxcarbazepine market size was valued at USD 436 million in 2023[1].

Q: What is the projected growth rate of the oxcarbazepine market?

The market is projected to grow at a CAGR of 6.8% from 2024 to 2030[1].

Q: Which regions are the most significant consumers of oxcarbazepine?

North America, Europe, and the Asia Pacific region are the most significant consumers of oxcarbazepine[1][4].

Q: What are the primary applications of oxcarbazepine?

The primary applications are the treatment of epilepsy, including partial seizures, and off-label use for bipolar disorder[1].

Q: How do generic versions impact the oxcarbazepine market?

Generic versions make the medication more accessible and affordable, contributing to market expansion but potentially reducing the market share and profitability of original manufacturers[1].

Cited Sources:

  1. Verified Market Research: Oxcarbazepine Drug Market Size & Forecast.
  2. FDA: Oxcarbazepine 202810 Clinical PREA.
  3. Cognitive Market Research: Oxcarbazepine Drug Market Report 2024 (Global Edition).
  4. ChemAnalyst: Oxcarbazepine market Size, Share, Growth & Forecast.

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