LAMOTRIGINE - Generic Drug Details

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

Lamotrigine is the generic ingredient in six branded drugs marketed by Owp Pharms, Glaxosmithkline Llc, Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Ph Health, Rubicon Research, Sciegen Pharms Inc, Torrent, Yiling, Zydus Pharms, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Pharmobedient, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Actavis Totowa, Aiping Pharm Inc, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Ipca Labs, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-seven NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has forty-four patent family members in thirty countries.

There are thirty-two drug master file entries for lamotrigine. Fifty-one suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for LAMOTRIGINE

International Patents:	44
US Patents:	3
Tradenames:	6
Applicants:	42
NDAs:	57
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	216
Patent Applications:	7,772
Drug Prices:	Drug price trends for LAMOTRIGINE
Drug Sales Revenues:	Drug sales revenues for LAMOTRIGINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAMOTRIGINE
What excipients (inactive ingredients) are in LAMOTRIGINE?	LAMOTRIGINE excipients list
DailyMed Link:	LAMOTRIGINE at DailyMed

See drug prices for LAMOTRIGINE

See drug sales revenues for LAMOTRIGINE

Recent Clinical Trials for LAMOTRIGINE

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

Sponsor	Phase
Lakshmi N Yatham	PHASE3
Bristol-Myers Squibb	PHASE3
Centre hospitalier de l'Universit de Montral (CHUM)	NA

See all LAMOTRIGINE clinical trials

Generic filers with tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	TABLET;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 LAMOTRIGINE

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

Anatomical Therapeutic Chemical (ATC) Classes for LAMOTRIGINE

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LAMOTRIGINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LAMICTAL XR	Extended-release Tablets	lamotrigine	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg	022115	1	2014-02-12
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 LAMOTRIGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078443-001	Feb 11, 2009		DISCN	No	No
Glenmark Pharms Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	090169-004	May 4, 2012	AB	RX	No	No
Ajanta Pharma Ltd	LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	213271-001	Jan 19, 2021	AB	RX	No	No

Expired US Patents for LAMOTRIGINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998	5,698,226*PED
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-006	Jun 21, 2011	9,144,547
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	9,144,547

International Patents for LAMOTRIGINE

Country	Patent Number	Title	Estimated Expiration
South Korea	100882707
United Kingdom	0217492
Colombia	5680405	FORMULACION DE LAMOTRIGINA DE LIBERACION PROLONGADA Y USO DE LA MISMA PARA SU PREPARACION

Market Dynamics and Financial Trajectory for Lamotrigine

Last updated: January 26, 2026

Executive Summary

Lamotrigine, marketed under brand names including Lamictal, is a widely prescribed anticonvulsant and mood stabilizer primarily used for epilepsy and bipolar disorder. Its global market has exhibited steady growth, influenced by expanding indications, evolving prescribing practices, and increasing prevalence of neuropsychiatric conditions. The compound’s patent landscape, manufacturing pipeline, and regulatory environment will shape its future financial trajectory. This report analyzes current market dynamics and forecasts Lamotrigine’s financial outlook through key factors such as market drivers, challenges, competitive landscape, and regulatory trends.

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Market Overview

Market Size and Growth (2022–2027)

Metric	2022 (USD Billion)	2027 (Forecast, USD Billion)	CAGR (2022–2027)
Global Lamotrigine Market	2.5	3.4	6.8%

Source: Fortunes Business Insights, 2022; IQVIA, 2023.

Indications and Usage

• Epilepsy: Approved for partial seizures and generalized epilepsy.
• Bipolar Disorder: Approved for maintenance treatment of bipolar I disorder.
• Off-label: Used in migraine prophylaxis and other neuropsychiatric conditions.

Regional Market Distribution (2022)

Region	Market Share (%)	Growth Drivers
North America	50	High prevalence, advanced healthcare infrastructure
Europe	20	Widespread acceptance, growing awareness
Asia-Pacific	15	Expanding healthcare access, increasing diagnosis rates
Rest of World	15	Emerging markets, generic penetration

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Key Market Drivers

1. Increasing Prevalence of Epilepsy and Bipolar Disorder

• Epilepsy: Affects approximately 50 million globally [1].
• Bipolar Disorder: Estimated at 45 million adults worldwide [2].
• Rising incidence fuels demand for effective, tolerated therapies like Lamotrigine.

2. Expansion of Therapeutic Indications and Off-label Use

• Clinical studies supporting Lamotrigine’s efficacy in migraine prevention and other neuropsychiatric disorders open new market segments.
• Growing off-label prescribing enhances revenue streams.

3. Patent Cliff and Generic Market Penetration

• Original patents expired around 2014–2018, leading to proliferation of generic versions.
• Generics comprise approximately 80% of prescriptions in mature markets [3].
• However, branded formulations retain premium pricing in select regions due to perceived quality and formulation stability.

4. Regulatory Approvals and Favorable Guidelines

• Regulatory endorsement by FDA, EMA, and other authorities facilitates wider adoption.
• Positive safety profile and minimal drug interactions bolster prescriber confidence.

5. Pricing Strategies and Reimbursement Policies

• Reimbursement-driven access in developed markets sustains demand.
• Tiered pricing and formulary placements influence market share expansion.

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Market Challenges

1. Competition from Other AEDs and Mood Stabilizers

Competitors	Drugs	Market Share (2022)	Key Features
Valproate	Valproic Acid	20%	Broad-spectrum anticonvulsant, teratogenicity concerns
Carbamazepine	Carbamazepine	10%	Established, but with safety issues
Lithium	Lithium Carbonate	8%	Mood stabilization, narrow therapeutic window
Newer Agents	Levetiracetam, Topiramate	20%	Favorable tolerability

• Newer agents with improved side effect profiles erode Lamotrigine’s market share in some segments.

2. Safety Concerns and Adverse Effects

• Risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) affects prescribing, especially in high-risk populations.
• Mandatory titration protocols prolong initiation phases and increase clinical oversight costs.

3. Generics Market Pressure

• Price erosion of generic Lamotrigine formulations constrains revenue.
• Limited differentiation among generics complicates brand loyalty.

4. Regulatory and Policy Shifts

• Off-label use restrictions and changes in reimbursement policies could impact sales trajectories.

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Competitive Landscape and Patent Status

Entity	Product	Patent Status	Market Share	Notes
GlaxoSmithKline (GSK)	Lamictal	Patent expired (2018)	Leading in branded segment	Facing generic competition
Mylan, Teva, Sandoz	Generic Lamotrigine	Patents expired	~80% of prescriptions	Price competition intense
Others	New formulations	Limited approvals	Niche segments	Development pipelines ongoing

Pipeline and Innovation Potential

• Efforts are underway to develop extended-release formulations and combination therapies.
• Biosimilars and novel analogs, though limited due to the compound’s small molecule status, may influence future market dynamics.

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Regulatory and Policy Trends

1. Approval Landscapes

• Regulatory agencies continue to approve generic versions with bioequivalence standards (FDA, EMA).
• Asian regulatory agencies (e.g., China NMPA) are streamlining approval processes, expanding market access.

2. Reimbursement Policies

• Globally, payers favor generics for cost-effectiveness.
• In some regions, off-label use reimbursement remains uncertain, impacting prescribing.

3. Clinical Guidelines

• National and international guidelines (e.g., NICE, American Epilepsy Society) recommend Lamotrigine as a first-line agent in specific indications.
• Incorporation into treatment algorithms sustains demand.

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Financial Trajectory Projections

Revenue Trends (2022–2027)

Year	Estimated Revenue (USD Billion)	Notes
2022	2.5	Base year
2023	2.66	Moderate growth due to expansion in Asia-Pacific
2024	2.84	Increased off-label use and new formulations
2025	3.05	Patent cliff effects stabilize
2026	3.30	Market saturation, new indications emerge
2027	3.40	Plateauing with potential decline in mature markets

Market Drivers Influencing Revenue

• Adoption of Lamotrigine in emerging markets.
• Pricing strategies in branded vs. generic segments.
• Development of combination therapies and remyelination indications.

Risks to Revenue Growth

• Accelerated generic erosion.
• Safety-related prescribing restrictions.
• Competition from newer agents with superior profiles.

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Comparative Analysis: Lamotrigine vs. Key Competitors

Feature	Lamotrigine	Valproic Acid	Lithium	Levetiracetam	Topiramate
Indications	Epilepsy, Bipolar	Epilepsy, Bipolar	Mood disorder	Epilepsy	Epilepsy, Migraine
Safety Profile	Minimal cognitive impairment	Teratogenicity	Narrow therapeutic window	Well tolerated	Cognitive side effects
Price (average wholesale, USD)	$0.50–$1.00 per tablet (generic)	$0.30–$0.70	$0.50–$2.00	$1.50–$3.00	$1.00–$2.00
Market Penetration	High but declining	Stable	Niche	Growing	Moderate

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Key Factors Impacting Future Market Dynamics

Factor	Impact	Strategic Consideration
Patent expirations	Increased generic penetration	Brand owners may seek extension via formulations
Off-label use expansion	Revenue growth opportunity	Investment in clinical trials to support new indications
Emerging markets growth	Accelerates adoption	Local manufacturing and pricing strategies
Clinical guideline updates	Prescribing patterns	Engagement with guideline committees
Safety concerns	Market stability	Robust pharmacovigilance and risk mitigation

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Key Takeaways

• Market Growth: Lamotrigine’s global market is projected to grow at a CAGR of ~6.8% until 2027, driven by expanding indications and emerging markets.

• Competitive Pressures: The dominant presence of low-cost generics limits branded revenue, demanding innovation and strategic partnerships.

• Pipeline and Innovation: Development of extended-release and combination formulations offers growth avenues—pending regulatory approval and clinical validation.

• Regulatory and Policy Shifts: Evolving policies, especially concerning off-label uses and safety management, influence prescribing patterns and reimbursement landscapes.

• Financial Outlook: Revenue growth may plateau post-2025 due to market saturation, with potential decline if new therapies outperform Lamotrigine in efficacy or safety.

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FAQs

1. What are the primary factors influencing Lamotrigine’s market growth?

Answer: The main drivers include increasing prevalence of epilepsy and bipolar disorder, expanding indications such as migraine prophylaxis, regulatory approvals, and market expansion into emerging regions. Conversely, patent expirations and competition from generics and newer therapies pose challenges.

2. How does patent expiration impact Lamotrigine’s revenue?

Answer: Patent expiration around 2018 led to widespread generic manufacturing, significantly reducing brand-name sales and putting pressure on pricing. Although generics dominate prescribing, branded formulations maintain higher margins through formulations and branding strategies.

3. What safety concerns could influence Lamotrigine’s market trajectory?

Answer: Risks like Stevens-Johnson syndrome and skin rash necessitate cautious titration and patient monitoring. Safety concerns can limit prescribing, especially in high-risk populations, affecting overall demand.

4. Are there opportunities for new formulations or delivery systems?

Answer: Yes. Extended-release formulations, combination therapies (e.g., Lamotrigine with other agents), and novel delivery systems (e.g., transdermal patches) could differentiate products and capture new market segments, contingent on successful development and approval.

5. How might regulatory policies evolve, affecting Lamotrigine’s market?

Answer: Potential restrictions on off-label use, tighter safety regulations, and reimbursement policies favoring cost-effective generics could influence prescribing patterns. Conversely, expanded approval for new indications could bolster sales.

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References

[1] World Health Organization. (2022). Epilepsy factsheet.

[2] American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

[3] IQVIA. (2023). Global Trends in Antiepileptic Drug Prescriptions.

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Note: Market projections are estimates based on current trends, regulatory environments, and available clinical data. Actual market performance may vary with unforeseen factors such as policy changes or breakthroughs in alternative therapies.