OXCARBAZEPINE - Generic Drug Details

What are the generic drug sources for oxcarbazepine and what is the scope of freedom to operate?

Oxcarbazepine is the generic ingredient in three branded drugs 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, Novartis, Ajanta Pharma Ltd, Apotex, Supernus Pharms, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-eight NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxcarbazepine has fourteen patent family members in ten countries.

There are twenty-one drug master file entries for oxcarbazepine. Thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for OXCARBAZEPINE

International Patents:	14
US Patents:	11
Tradenames:	3
Applicants:	24
NDAs:	28
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	63
Patent Applications:	6,220
Drug Prices:	Drug price trends for OXCARBAZEPINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXCARBAZEPINE
What excipients (inactive ingredients) are in OXCARBAZEPINE?	OXCARBAZEPINE excipients list
DailyMed Link:	OXCARBAZEPINE at DailyMed

See drug prices for OXCARBAZEPINE

See drug sales revenues for OXCARBAZEPINE

Recent Clinical Trials for OXCARBAZEPINE

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4
Postgraduate Institute of Dental Sciences Rohtak	Phase 4

See all OXCARBAZEPINE clinical trials

Generic filers with tentative approvals for OXCARBAZEPINE

Applicant	Application No.	Strength	Dosage Form
		600MG	TABLET, EXTENDED RELEASE;ORAL
		300MG	TABLET, EXTENDED RELEASE;ORAL
		150MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OXCARBAZEPINE

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for OXCARBAZEPINE

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Ajanta Pharma Ltd	OXCARBAZEPINE	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	217659-002	Feb 22, 2024		DISCN	No	No
Rubicon	OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	077747-001	Apr 9, 2008	AB	RX	No	No
Hikma	OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	077795-001	Oct 9, 2007		DISCN	No	No
Jubilant Cadista	OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	090239-002	Jan 25, 2010		DISCN	No	No
Ajanta Pharma Ltd	OXCARBAZEPINE	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	217659-001	Feb 22, 2024		DISCN	No	No
Biocon Pharma	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	218278-001	Mar 1, 2024	AB	RX	No	No
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No	7,910,131

Expired US Patents for OXCARBAZEPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	7,037,525*PED
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	7,037,525*PED
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-002	Jan 14, 2000	7,037,525*PED
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-001	Jan 14, 2000	7,037,525*PED
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	8,119,148*PED

International Patents for OXCARBAZEPINE

Country	Patent Number	Title	Estimated Expiration
Japan	2009535351
Spain	2396051
Canada	2597740	PREPARATIONS A LIBERATION MODIFIEE CONTENANT DE L'OXCARBAZEPINE ET SES DERIVES (MODIFIED-RELEASE PREPARATIONS CONTAINING OXCARBAZEPINE AND DERIVATIVES THEREOF)
Spain	2360423
Mexico	2008013675	PREPARACIONES DE LIBERACION CONTROLADA DE OXCARBACEPINA QUE TIENEN PERFIL DE LIBERACION SIGMOIDAL. (CONTROLLED RELEASED PREPARATIONS OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE.)
Austria	E496623
Japan	5253381

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.