TRILEPTAL Drug Patent Profile

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

Trileptal is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in TRILEPTAL 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 Trileptal

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

Summary for TRILEPTAL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	24
Patent Applications:	5,173
Drug Prices:	Drug price information for TRILEPTAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRILEPTAL
What excipients (inactive ingredients) are in TRILEPTAL?	TRILEPTAL excipients list
DailyMed Link:	TRILEPTAL at DailyMed

See drug prices for TRILEPTAL

See drug sales revenues for TRILEPTAL

Recent Clinical Trials for TRILEPTAL

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital	Phase 4
Collaborative Care Initiative, LLC	Phase 4

See all TRILEPTAL clinical trials

Pharmacology for TRILEPTAL

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

Paragraph IV (Patent) Challenges for TRILEPTAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 TRILEPTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	AB	RX	Yes	Yes
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	AB	RX	Yes	Yes
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-001	Jan 14, 2000	AB	RX	Yes	No

Expired US Patents for TRILEPTAL

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

International Patents for TRILEPTAL

See the table below for patents covering TRILEPTAL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69814367
Turkey	200402419
New Zealand	518755	Suspension comprising oxcarbazepine

TRILEPTAL Market Analysis and Financial Projection Experimental

Oxcarbazepine (Trileptal) Market Dynamics and Financial Trajectory

Overview of Oxcarbazepine (Trileptal)

Oxcarbazepine, marketed under the brand name Trileptal by Novartis, is an antiepileptic medication primarily used to treat epilepsy and bipolar disorder. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Forecast

The oxcarbazepine drug market was valued at USD 436 million in 2023 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][3][4].

Key Drivers of Market Growth

Growing Epilepsy Prevalence

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

Increasing Awareness and Diagnosis

Greater awareness and diagnosis of epilepsy and other conditions treated by oxcarbazepine contribute to the market's growth. More people seeking medical help for these conditions translate into higher demand for the medication[1].

Developments in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing nations, enhance access to diagnosis and treatment, thereby expanding the market for oxcarbazepine[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 crucial role in increasing access to care and thus driving market growth[1].

Market Segmentation

By Type

The oxcarbazepine market is segmented into tablets (available in 150mg, 300mg, and 600mg doses) and oral suspension. The tablet segment accounts for a significant share of the global market and is expected to experience significant growth[4].

By Application

The market is segmented by end-user into pediatric use (aged 2-4 years and 4-16 years) and adult use. Each segment has its own growth trajectory, with adult use expected to maintain a strong CAGR during the forecast period[3].

By Geography

The global oxcarbazepine market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are significant markets due to high prevalence rates of epilepsy and bipolar disorder, while the Asia Pacific region is witnessing growth due to increasing awareness and improving healthcare infrastructure[1][4].

Competitive Landscape

Leading Players

The market includes major players such as Novartis (Trileptal), Supernus Pharmaceuticals (Oxtellar XR), Sun Pharm, Ranbaxy Pharmaceuticals, Jubilant Generics, Taro Pharmaceuticals, Mylan, Stada Group, Glenmark Pharmaceuticals, ANI Pharmaceuticals, Teva Pharmaceutical, Roxane Laboratories, and Nobelpharma[3].

Challenges and Restraints

Patent Expiration

The expiration of patents for oxcarbazepine allows more generic manufacturers to enter the market, potentially reducing the market share and profitability of original manufacturers like Novartis[1].

Regulatory Obstacles

Strict regulations, especially in key markets, can hinder market entry or growth. Regulatory changes can impact the dynamics of the oxcarbazepine market, particularly those related to drug approvals and pricing[1].

Side Effects and Safety Issues

Reports of serious side effects or safety issues can negatively impact the market by reducing acceptance or leading to regulatory actions[1].

Alternative Therapies

The availability of alternative antiepileptic medications can constrain the market growth of oxcarbazepine. Patients and healthcare providers may opt for other treatments if they are perceived as safer or more effective[1].

Market Saturation

In developed markets where Trileptal has already gained broad acceptance, market saturation can limit further expansion opportunities[1].

Price Sensitivity

Price competition, especially in regions with limited healthcare reimbursement, can affect market expansion and profitability[1].

Technological Advancements

The emergence of better, safer, or more effective competitors can reduce the competitiveness and market demand for oxcarbazepine. Continuous research and development are crucial to maintaining the drug's market position[1].

Financial Impact

Revenue Growth

The projected growth of the oxcarbazepine market from USD 436 million in 2023 to USD 630.9 million by 2030 indicates a robust financial trajectory. This growth is driven by increasing demand and expanding market segments[1][3][4].

Competitive Strategies

Leading companies in the oxcarbazepine market adopt various strategies such as product mix optimization, advertising, and expanding their product portfolios to maintain market share. For instance, Novartis's financial data shows significant sales from its top products, including Trileptal[5].

Regional Analysis

North America

This region, including the United States and Canada, has a significant market for oxcarbazepine due to the high prevalence of epilepsy and bipolar disorder[1].

Europe

European countries also have a sizable market, with a focus on accessibility and affordability of the drug[1].

Asia Pacific

This region is experiencing growth due to increasing awareness and improving healthcare infrastructure. Countries like India and China are key markets in this region[1].

Latin America and Middle East & Africa

These regions are also significant, driven by increasing healthcare expenditure and improving access to healthcare services[1].

Key Takeaways

• The oxcarbazepine market is expected to grow significantly, driven by increasing epilepsy prevalence and improving healthcare infrastructure.
• The market is segmented by type, application, and geography, with tablets being the dominant form.
• Leading players like Novartis face challenges from generic versions and regulatory obstacles.
• Continuous research and development are essential to maintain market competitiveness.
• Regional growth varies, with North America and Europe being key markets and the Asia Pacific region showing promising growth.

FAQs

What is the projected market size of oxcarbazepine by 2030?

The oxcarbazepine market is projected to reach USD 630.9 million by 2030[1].

What are the main drivers of the oxcarbazepine market growth?

Key drivers include growing epilepsy prevalence, increasing awareness and diagnosis, developments in healthcare infrastructure, and a growing geriatric population[1].

Which region is expected to dominate the global oxcarbazepine market?

North America is expected to remain a significant market, but the Asia Pacific region is witnessing substantial growth due to increasing awareness and improving healthcare infrastructure[1].

What are the challenges faced by the original manufacturers of oxcarbazepine?

Challenges include patent expiration, regulatory obstacles, side effects and safety issues, alternative therapies, market saturation, and price sensitivity[1].

How does the competitive landscape of the oxcarbazepine market look?

The market includes major players like Novartis, Supernus Pharmaceuticals, and several generic manufacturers. These companies employ various strategies to maintain market share[3].

What impact do technological advancements have on the oxcarbazepine market?

Technological advancements can lead to the emergence of better, safer, or more effective competitors, potentially reducing the market demand for oxcarbazepine[1].

Sources

1. Verified Market Research: Oxcarbazepine Drug Market Size & Forecast[1]
2. Justice Department: Novartis Pharmaceuticals Corp. to Pay More Than $420 Million to Resolve Label Promotion and Kickback Allegations[2]
3. OpenPR: Oxcarbazepine Market to Observe Strong Development by 2030[3]
4. Cognitive Market Research: Oxcarbazepine Drug Market Report 2024 (Global Edition)[4]
5. Novartis: Product sales | Novartis[5]