LAMICTAL Drug Patent Profile

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

Lamictal is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. There is one patent protecting this drug.

The generic ingredient in LAMICTAL 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

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

Summary for LAMICTAL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	94
Patent Applications:	4,810
Drug Prices:	Drug price information for LAMICTAL
Drug Sales Revenues:	Drug sales revenues for LAMICTAL
What excipients (inactive ingredients) are in LAMICTAL?	LAMICTAL excipients list
DailyMed Link:	LAMICTAL at DailyMed

See drug prices for LAMICTAL

See drug sales revenues for LAMICTAL

Recent Clinical Trials for LAMICTAL

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

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

See all LAMICTAL clinical trials

Pharmacology for LAMICTAL

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

US Patents and Regulatory Information for LAMICTAL

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	lamotrigine	TABLET;ORAL	020241-005	Dec 27, 1994	AB	RX	Yes	Yes
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	AB	RX	Yes	Yes			Y
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000	AB	RX	Yes	No
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-002	Dec 27, 1994	AB	RX	Yes	No

Expired US Patents for LAMICTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-001	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-002	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-005	Dec 27, 1994

International Patents for LAMICTAL

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

Country	Patent Number	Title	Estimated Expiration
Finland	801758
Greece	68380
Australia	530999
Canada	1133938	COMPOSES AROMATIQUES SUBSTITUES (SUBSTITUTED AROMATIC COMPOUNDS)

Supplementary Protection Certificates for LAMICTAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0021121	94C0016	Belgium		94C0016, 19941006

Market Dynamics and Financial Trajectory for Lamotrigine (Lamictal)

Introduction

Lamotrigine, marketed under the brand name Lamictal, is an antiseizure drug approved by the US FDA in 1994 for treating focal (partial) seizures, epilepsy, and bipolar disorder. The market for lamotrigine is driven by several key factors, including the growing prevalence of neurological and mood disorders, advancements in healthcare infrastructure, and favorable regulatory environments.

Growing Prevalence of Neurological and Mood Disorders

The increasing incidence of epilepsy and bipolar disorder is a significant driver of the lamotrigine market. These conditions are becoming more prevalent, leading to higher demand for effective treatments. According to Cognitive Market Research, the growing prevalence of these disorders is fueling the sales of lamotrigine globally[1].

Regional Market Analysis

North America

North America holds a major share of the global lamotrigine market, accounting for around 40% of the global revenue. The robust healthcare infrastructure, high diagnosis rates, and favorable reimbursement policies in this region contribute to the increased sales of lamotrigine. The aging population and rising mental health awareness also drive demand for treatments targeting neurological and mood disorders[1].

Europe

Europe accounts for approximately 30% of the global lamotrigine market. The region's expanding healthcare expenditure and infrastructure, along with initiatives promoting mental health awareness, are key factors driving the market growth. The presence of leading pharmaceutical companies and stringent regulatory standards further enhance the market[1].

Asia Pacific

The Asia Pacific region is experiencing significant growth, with a CAGR of 7.0% from 2024 to 2031. Rising healthcare expenditure, improving access to healthcare services, and growing awareness campaigns about neurological and mood disorders are driving the demand for lamotrigine. The large pediatric population in this region, particularly those with epilepsy, also contributes to the market growth[1].

Latin America

Latin America accounts for around 5% of the global lamotrigine market and is expected to grow at a CAGR of 4.4% from 2024 to 2031. Expanding healthcare infrastructure, increasing urbanization, and rising awareness about mental health are key drivers. The aging population and partnerships between pharmaceutical companies and healthcare organizations also enhance market penetration[1].

Middle East and Africa

The Middle East and Africa region holds around 2% of the global market share and is expected to grow at a CAGR of 4.7% from 2024 to 2031. Improving healthcare infrastructure, rising healthcare spending, and increasing awareness about neurological disorders are driving the demand for lamotrigine in this region[1].

Market Segmentation

By Type

The global lamotrigine market is segmented into two main types based on purity: Purity 98%-99% and Purity 99%. The Purity 98%-99% segment is anticipated to hold a prominent share in the market due to its widespread use and acceptance[4].

By Application

The market is segmented into two primary applications: epilepsy and bipolar disorder. Lamotrigine's efficacy in managing both conditions solidifies its position in these segments. The drug is particularly effective in treating epilepsy, which is a prevalent neurological condition globally[4].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the global lamotrigine market. Seizures and epilepsy can be complications of COVID-19, leading to an increased demand for lamotrigine. The pandemic has accelerated the growth of the lamotrigine market due to the rising number of cases and the associated neurological complications[4].

Financial Performance and Projections

Global Market Size

The global lamotrigine market size is estimated to grow at a CAGR of 5.00% from 2024 to 2031. The market is driven by the increasing demand for effective treatments for epilepsy and bipolar disorder, as well as favorable market conditions in various regions[1].

Revenue and Growth

North America, with its robust healthcare infrastructure and high diagnosis rates, is expected to continue leading the market. Europe and the Asia Pacific region are also anticipated to see significant growth due to expanding healthcare expenditure and improving access to healthcare services. The global market is projected to benefit from these regional growth trends, leading to an overall increase in revenue[1].

Key Players and Competitive Landscape

Major pharmaceutical companies play a crucial role in the lamotrigine market. Companies like GlaxoSmithKline (GSK), which has a strong presence in the pharmaceutical industry, contribute to the market growth through their research and development efforts and strategic partnerships. For instance, GSK's financial performance in 2022 reflected strong growth in various segments, including general medicines, which includes lamotrigine[2].

Regulatory Environment

Stringent regulatory standards in regions like Europe ensure the quality and safety of medications, enhancing consumer confidence. Regulatory approvals and favorable policies also facilitate the market growth by making lamotrigine more accessible to patients[1].

Research and Development

Continuous research and development efforts are crucial for the lamotrigine market. Improvements in the technology behind mental-disorder drugs and the development of new formulations and delivery systems are expected to further solidify lamotrigine's market position. For example, advancements in telemedicine and e-prescription systems have facilitated medication procurement, particularly in the Asia Pacific region[1][4].

Illustrative Statistics

• Global Market Growth: The global lamotrigine market is expected to grow at a CAGR of 5.00% from 2024 to 2031[1].
• Regional Market Share: North America holds around 40% of the global market share, followed by Europe with around 30%, and the Asia Pacific with around 23%[1].
• COVID-19 Impact: The COVID-19 pandemic has led to an increased demand for lamotrigine due to associated neurological complications[4].

Quotes from Industry Experts

"Lamotrigine is well-positioned to cater to the growing demand, particularly in hospital pharmacies, due to its proven efficacy in managing epilepsy and bipolar disorder," - Cognitive Market Research[1].

Key Takeaways

• The global lamotrigine market is driven by the growing prevalence of epilepsy and bipolar disorder.
• North America, Europe, and the Asia Pacific are key regions contributing to the market growth.
• The COVID-19 pandemic has accelerated the demand for lamotrigine.
• Continuous research and development efforts are essential for market growth.
• Favorable regulatory environments and robust healthcare infrastructure support the market.

FAQs

What are the primary applications of lamotrigine?

Lamotrigine is primarily used to treat epilepsy and bipolar disorder.

How has the COVID-19 pandemic impacted the lamotrigine market?

The COVID-19 pandemic has increased the demand for lamotrigine due to associated neurological complications such as seizures and epilepsy.

Which region holds the largest market share for lamotrigine?

North America holds the largest market share for lamotrigine, accounting for around 40% of the global revenue.

What is the expected CAGR of the global lamotrigine market from 2024 to 2031?

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

What are the key factors driving the growth of the lamotrigine market in the Asia Pacific region?

The growth in the Asia Pacific region is driven by rising healthcare expenditure, improving access to healthcare services, and growing awareness campaigns about neurological and mood disorders.

Sources

1. Cognitive Market Research: Lamotrigine Market Report.
2. GSK: Full-year and fourth quarter 2022 results announcement.
3. PharmGKB: Lamotrigine Pathway, Pharmacokinetics and Pharmacodynamics.
4. OMR Global: Lamotrigine Market Size, Analysis Report & Forecast to 2028.
5. Eton Pharmaceuticals: Fourth Quarter 2021 Financial Results.