LAMICTAL ODT Drug Patent Profile

When do Lamictal Odt patents expire, and when can generic versions of Lamictal Odt launch?

Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lamictal Odt

A generic version of LAMICTAL ODT was approved as lamotrigine by DR REDDYS LABS LTD on January 22^nd, 2009.

Summary for LAMICTAL ODT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	94
Patent Applications:	4,333
Drug Prices:	Drug price information for LAMICTAL ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAMICTAL ODT
DailyMed Link:	LAMICTAL ODT at DailyMed

See drug prices for LAMICTAL ODT

See drug sales revenues for LAMICTAL ODT

Recent Clinical Trials for LAMICTAL ODT

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Brown University	Phase 2

See all LAMICTAL ODT clinical trials

Pharmacology for LAMICTAL ODT

Drug Class	Anti-epileptic Agent Mood Stabilizer
Mechanism of Action	Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for LAMICTAL ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LAMICTAL ODT	Orally Disintegrating Tablets	lamotrigine	25 mg, 50 mg, 100 mg, and 200 mg	022251	1	2009-12-21

US Patents and Regulatory Information for LAMICTAL ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-001	May 8, 2009	AB	RX	Yes	No
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-004	May 8, 2009	AB	RX	Yes	No
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-002	May 8, 2009	AB	RX	Yes	Yes
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-003	May 8, 2009	AB	RX	Yes	No

International Patents for LAMICTAL ODT

See the table below for patents covering LAMICTAL ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2693072	COMPOSITIONS DE COMPRIMÉ À DÉSINTÉGRATION PAR VOIE ORALE DE LAMOTRIGINE (Orally disintegrating tablet compositions of lamotrigine.)
Hong Kong	1201745	拉莫三嗪的口服崩解片劑組合物 (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE)
New Zealand	582458	ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE
Japan	2010532384

Market Dynamics and Financial Trajectory for Lamictal ODT

Introduction

Lamictal ODT, the orally disintegrating tablet formulation of lamotrigine, is a significant player in the pharmaceutical market, particularly in the treatment of epilepsy and bipolar disorder. This article delves into the market dynamics and financial trajectory of Lamictal ODT, highlighting its current status, growth prospects, and regional performance.

Global Market Size and Growth Rate

The global lamotrigine market, which includes Lamictal ODT, is projected to grow at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031. As of 2024, the global lamotrigine market size is estimated to be USD XX million, with a forecasted expansion driven by increasing healthcare expenditure and improving access to healthcare services[1].

Regional Market Performance

Europe

Europe holds a significant share of the global lamotrigine market, accounting for around 30% of the global revenue. The region is expected to grow at a CAGR of 3.5% from 2024 to 2031. This growth is attributed to expanding healthcare infrastructure, increasing mental health awareness, and the presence of leading pharmaceutical companies. Hospital pharmacies in Europe dominate the market due to their established distribution networks and trusted relationships with healthcare providers[1].

Asia Pacific

The Asia Pacific region is a key growth area for lamotrigine, with a CAGR of 7.0% from 2024 to 2031. This rapid growth is driven by rising healthcare expenditure, improving access to healthcare services, and growing awareness about neurological and mood disorders. The region's large pediatric population and the efficacy of lamotrigine in treating pediatric epilepsy further contribute to its market growth[1].

Latin America

In Latin America, the lamotrigine market is expected to grow at a CAGR of 4.4% from 2024 to 2031. The region's expanding healthcare infrastructure, increasing urbanization, and rising awareness about mental health are key drivers. The demand for lamotrigine is particularly high in the treatment of bipolar disorder, where its effectiveness in stabilizing mood swings is well recognized[1].

North America and Middle East & Africa

North America is expected to grow at a CAGR of 3.2% from 2024 to 2031, while the Middle East and Africa region will see a CAGR of 4.7% during the same period. These regions also benefit from increasing healthcare expenditure and improving access to healthcare services, although at a slower pace compared to Asia Pacific[1].

Product Indications and Usage

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in adults. It is also used in combination with other medicines to treat certain types of seizures, including partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in people two years or older. The orally disintegrating formulation is particularly beneficial for patients who have difficulty swallowing traditional tablets[2].

Market Drivers

Increasing Healthcare Expenditure

Rising healthcare expenditure globally is a significant driver for the lamotrigine market. As healthcare infrastructure improves, more people have access to diagnostic and treatment services, leading to increased demand for medications like Lamictal ODT[1].

Growing Awareness of Neurological and Mood Disorders

Awareness campaigns about neurological and mood disorders are driving diagnosis rates and treatment-seeking behavior. This increased awareness, particularly in regions like Asia Pacific and Latin America, contributes to the growing demand for lamotrigine[1].

Advancements in Drug Delivery

The orally disintegrating tablet (ODT) formulation of lamotrigine offers a convenient and patient-friendly option, especially for older and pediatric patients who may have difficulty swallowing traditional tablets. This formulation enhances drug adherence and provides a more convenient option, contributing to its market growth[4].

Competitive Landscape

Generic Versions

The approval of generic versions of Lamictal ODT, such as those by Impax Laboratories, has introduced competition into the market. Generic versions offer cost-effective alternatives, which can impact the market share of the branded product. However, the first-to-market generic versions often enjoy a period of market exclusivity, which can mitigate some of the competitive pressure[5].

Brand Loyalty and Quality Standards

Despite the presence of generics, the branded version of Lamictal ODT maintains a strong market position due to its established reputation and stringent regulatory standards ensuring quality and safety. This brand loyalty, particularly among healthcare providers, continues to support the market performance of Lamictal ODT[1].

Financial Performance

Revenue and Sales

The U.S. sales of Lamictal ODT were approximately $56 million for the 12 months ended November 2014. While specific current revenue figures are not provided, the overall growth trajectory of the lamotrigine market suggests continued revenue growth driven by expanding market share and increasing demand[5].

Market Projections

The global lamotrigine market is expected to expand significantly over the forecast period, driven by the factors mentioned above. The CAGR of 5.00% from 2024 to 2031 indicates a steady and predictable growth path, making it an attractive segment for pharmaceutical companies and investors[1].

Orally Disintegrating Tablet Market Context

The broader orally disintegrating tablet (ODT) market is also experiencing significant growth, with a projected CAGR of 8.1% from 2024 to 2034. This growth is driven by the increasing demand for convenient and patient-friendly drug formulations, particularly in regions with high prevalence of chronic ailments like diabetes, cardiovascular disease, and neurological disorders[4].

Key Takeaways

• The global lamotrigine market, including Lamictal ODT, is expected to grow at a CAGR of 5.00% from 2024 to 2031.
• Regional growth varies, with Asia Pacific showing the highest CAGR of 7.0%.
• Increasing healthcare expenditure, growing awareness of neurological and mood disorders, and advancements in drug delivery are key market drivers.
• The orally disintegrating formulation of lamotrigine offers significant benefits, particularly for patients with difficulty swallowing traditional tablets.
• Generic versions of Lamictal ODT introduce competition but do not significantly erode the market share of the branded product due to brand loyalty and quality standards.

FAQs

What is Lamictal ODT used for?

Lamictal ODT is used for the long-term treatment of Bipolar I Disorder and for treating certain types of seizures, including partial seizures and generalized seizures of Lennox-Gastaut syndrome.

What is the global growth rate of the lamotrigine market?

The global lamotrigine market is expected to grow at a CAGR of 5.00% from 2024 to 2031.

Which region has the highest growth rate for lamotrigine?

The Asia Pacific region has the highest growth rate for lamotrigine, with a CAGR of 7.0% from 2024 to 2031.

What are the key drivers of the lamotrigine market?

Key drivers include increasing healthcare expenditure, growing awareness of neurological and mood disorders, and advancements in drug delivery formulations.

Are there generic versions of Lamictal ODT available?

Yes, generic versions of Lamictal ODT are available, such as those approved by Impax Laboratories, which offer cost-effective alternatives to the branded product.

How does the orally disintegrating tablet formulation benefit patients?

The ODT formulation benefits patients, especially older and pediatric patients, by providing a convenient and easy-to-take option that disintegrates on the tongue, enhancing drug adherence and treatment outcomes.

Sources

1. Cognitive Market Research: "Global Lamotrigine Market Report 2024"
2. Biospace: "FDA Approves GlaxoSmithKline's Lamictal(R) ODT(TM) Orally Disintegrating Tablets"
3. Drugs.com: "Generic Lamictal ODT Availability"
4. Precedence Research: "Orally Disintegrating Tablet Market Size to Hit USD 31.80 Bn by 2034"
5. Impax Laboratories: "Impax Receives FDA Approval for a Generic Version of Lamictal Orally Disintegrating Tablets"

Last updated: 2024-12-17