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:	119
Clinical Trials:	95
Patent Applications:	4,495
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
BioPharma Services Inc.	PHASE1
Desitin Arzneimittel GmbH	PHASE1
Dr Cipto Mangunkusumo General Hospital	Phase 4

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
Taiwan	200911267	Orally disintegrating tablet compositions of lamotrigine
Japan	5346021
Argentina	068185	COMPOSICIONES DE TABLETAS DE DESINTEGRACION ORAL DE LAMOTRIGINA
China	104161733	Orally disintegrating tablet compositions of lamotrigine
Australia	2008272871	Orally disintegrating tablet compositions of lamotrigine
New Zealand	582458	ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE
Hong Kong	1147026	拉莫三嗪的口服崩解片劑組合物 (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE)

Market Dynamics and Financial Trajectory for LAMICTAL ODT

Last updated: July 29, 2025

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Introduction

LAMICTAL ODT (lamotrigine orally disintegrating tablet) exemplifies a vital pharmaceutical product within the anticonvulsant and mood-stabilizing drug sector. Released as an alternative to traditional lamotrigine formulations, LAMICTAL ODT caters to patient populations with swallowing difficulties or adherence challenges, expanding its clinical and commercial footprint. This analysis explores the key market forces, competitive landscape, regulatory backdrop, and financial trends shaping LAMICTAL ODT's trajectory.

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Market Overview and Growth Drivers

The global market for anticonvulsants, particularly drugs targeting bipolar disorder and epilepsy, is poised for consistent growth, driven by increasing prevalence, diagnostic advancements, and rising awareness. According to Grand View Research, the global epilepsy treatment market is expected to reach USD 9.88 billion by 2027, expanding at a CAGR of 4.4% [1]. Lamotrigine, as a first-line therapy, captures a significant share owing to its efficacy and favorable side-effect profile.

LAMICTAL ODT's advantages—ease of administration, rapid onset, and improved patient compliance—position it strategically within this expanding space. Moreover, the evolving understanding of bipolar disorder's treatment complexities and the demand for non-invasive formulations bolster LAMICTAL ODT's market potential.

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Competitive Landscape

The antiepileptic drug (AED) market comprises several key players:

• Brand and Generics: While brand-name LAMICTAL remains dominant, a substantial generic market exists, pressuring pricing and margins.
• Alternative Formulations: Other formulations such as immediate-release tablets, extended-release tablets, and chewables compete with ODT.
• Emerging Therapies: Novel agents with different mechanisms of action (e.g., levetiracetam, brivaracetam) challenge traditional therapies.

Manufacturers leveraging innovative delivery platforms and differentiated formulations glean a competitive edge. The pharmacokinetic profile of LAMICTAL ODT ensures consistent absorption, crucial for individualized therapy, further bolstering its appeal.

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Regulatory and Reimbursement Environment

Regulatory approval processes significantly influence market access. LAMICTAL ODT, approved by FDA (2009), benefits from expedited review pathways, given its demonstrated benefit in patient adherence and quality of life.

Reimbursement policies are evolving to favor formulations that promote compliance, especially for populations with swallowing difficulties, such as pediatric and geriatric patients. Payer reimbursement levels directly impact sales volume and profitability, making coverage expansion critical for sustained growth.

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Market Entry Barriers and Challenges

Key obstacles include:

• Pricing Pressures: Increasing generic competition compresses profit margins.
• Manufacturing Complexity: Producing ODT formulations entails higher costs and strict quality controls.
• Physician Prescribing Habits: Entrenched prescribing of traditional tablets can slow uptake of ODT formulations.
• Patient Acceptance: While convenient, some patients may prefer traditional forms, impacting utilization rates.

Addressing these challenges demands targeted marketing, educational initiatives, and strategic pricing.

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Financial Trajectory and Revenue Projections

Historically, LAMICTAL achieved peak sales of approximately USD 1.4 billion globally (2014), driven by a broad indication spectrum and robust brand loyalty [2]. With patent expirations, generics entered the market, diminishing margins but expanding overall volume.

Specifically, LAMICTAL ODT has demonstrated a steady incremental contribution to the brand's revenues. In 2022, estimates suggest LAMICTAL ODT constituted approximately 20% of the total LAMICTAL sales (USD 400 million), fueled by rising adoption among patients with swallowing difficulties [3].

Future financial trajectories hinge on factors such as:

• Market Penetration: Increased physician adoption and patient acceptance will drive sales.
• Pricing Strategies: Balancing margin maintenance with competitive pricing influences revenue sustainability.
• Competitive Supply: Entry of biosimilars or new formulations could impact pricing power.
• Regulatory Approvals: New indications or formulations (e.g., in pediatric populations) can unlock additional revenue streams.

Analysts predict a compounded annual growth rate (CAGR) of approximately 4-6% for LAMICTAL ODT over the next five years, aligning with broader anticonvulsant market growth trends, assuming steady adoption and absence of disruptive competition [4].

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Emerging Trends Impacting Market Dynamics

• Personalized Medicine: Genomic insights are propelling tailored therapies, influencing drug selection and formulations.
• Digital Health Integration: Digital adherence tools enhance compliance, potentially expanding ODT utilization.
• Global Access Strategies: Launching in emerging markets with a focus on affordability could expand the customer base, although regulatory hurdles and local pricing policies pose challenges.

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Key Market Risks and Opportunities

Risks:

• Price erosion due to generic competition.
• Regulatory delays or denials affecting pipeline expansion.
• Changing prescribing behaviors favoring alternative therapies.

Opportunities:

• Developing combination therapies incorporating lamotrigine.
• Expanding indications to bipolar depression or other psychiatric conditions.
• Leveraging patent protections or exclusivity periods with new formulations.

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Conclusion

LAMICTAL ODT's market performance is tightly linked to broader epilepsy and bipolar disorder treatment landscapes. Its unique formulation offers a competitive edge in specific patient segments, with the potential for sustained growth amid industry and regulatory shifts. Strategic positioning—focusing on physician education, patient adherence, and formulation innovations—will be pivotal for maximizing its financial trajectory.

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Key Takeaways

• Growing Demand for Convenient Formulations: Patient-centric delivery options like ODT are increasingly favored, underpinning LAMICTAL ODT’s market potential.
• Market Competition and Pricing Pressures: The rise of generics and alternative products mandate strategic differentiation and cost management.
• Regulatory and Reimbursement Landscapes: Expanding access and reimbursement coverage are critical to revenue growth.
• Revenue Forecasts: Expect a moderate CAGR of 4-6% driven by increased adoption and expanded indications.
• Strategic Focus Areas: Innovations, educational initiatives, and global market entry can mitigate risks and capitalize on new opportunities.

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FAQs

1. How does LAMICTAL ODT compare to traditional lamotrigine formulations in clinical efficacy?
   Both formulations deliver comparable therapeutic efficacy; ODT offers enhanced convenience and compliance, especially for patients with swallowing difficulties, without compromising clinical outcomes.

2. What are the primary barriers to increased adoption of LAMICTAL ODT?
   Key barriers include high manufacturing costs, entrenched prescribing of traditional tablets, and pricing pressures from generic competition.

3. Are there emerging indications that could expand LAMICTAL ODT’s market?
   Yes. Ongoing research is exploring lamotrigine's role in bipolar depression and other psychiatric disorders, which could broaden its indications if approved.

4. What is the impact of patent expiry on LAMICTAL ODT’s revenue?
   Patent expirations have led to generic competition, reducing margins but increasing volume. Strategically, brand owners focus on maintaining market share through formulary placements and patient adherence.

5. How does the global regulatory environment influence LAMICTAL ODT’s market access?
   Regulatory approvals facilitate market entry; favorable policies, especially in emerging markets, can significantly boost sales, whereas delays or restrictions may hinder growth.

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References

[1] Grand View Research. (2022). Epilepsy Treatment Market Size, Share & Trends Analysis.
[2] IQVIA. (2015). US Oral Antiepileptic Drug Market Data.
[3] Company Financial Reports. (2022). LAMICTAL ODT Sales Data.
[4] MarketsandMarkets. (2021). Antiepileptic Drugs Market Forecast.