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:	215
Patent Applications:	7,979
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
Karuna Therapeutics	PHASE1

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
Zydus Pharms Usa	LAMOTRIGINE	lamotrigine	TABLET;ORAL	077633-003	Jan 27, 2009	AB	RX	No	No
Alembic	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	211821-002	Oct 1, 2024	AB	RX	No	No
Amring Pharms	LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	214124-004	Feb 3, 2022	AB	RX	No	No
Granules	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078982-002	Jan 27, 2009		DISCN	No	No
Torrent Pharms	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078947-001	Jan 27, 2009	AB	RX	No	No
Aiping Pharm Inc	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078645-004	Jan 27, 2009		DISCN	No	No
Glenmark Pharms Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	090169-003	May 4, 2012	AB	RX	No	No

Expired US Patents for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-001	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-005	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000

International Patents for lamotrigine

Country	Patent Number	Title	Estimated Expiration
United Kingdom	0217492
Malaysia	141049	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE
Japan	4744142
South Africa	200500518	Sustained release formulations comprising lamotrigine
European Patent Office	1524981	FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE (SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE)
Iceland	2681
Argentina	040709	FORMULACION DE LAMOTRIGINA DE LIBERACION PROLONGADA Y USO DE LA MISMA PARA SU PREPARACION

Market Dynamics and Financial Trajectory for Lamotrigine: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

Lamotrigine, marketed under brand names such as Lamictal and Lamictal XR, is a widely prescribed anticonvulsant and mood stabilizer primarily used in the management of epilepsy and bipolar disorder. Since its FDA approval in 1994, lamotrigine has experienced sustained demand driven by its efficacy, safety profile, and expanding therapeutic indications. This report examines the evolving market landscape, competitive forces, regulatory influences, and financial prospects shaping the future trajectory of lamotrigine within the global pharmaceutical industry.

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Market Overview and Current Landscape

Global Market Size

The global antiepileptic drugs (AEDs) market was valued at approximately USD 4.2 billion in 2022 and is projected to reach USD 6.5 billion by 2030, growing at a CAGR of around 5.5% [1]. Lamotrigine accounts for a significant segment of this market, attributed to its dual indications and favorable safety profile compared to older AEDs like phenytoin and carbamazepine.

Key Indications and Demographics

Lamotrigine's primary indications include:

• Epilepsy: Especially generalized tonic-clonic and partial seizures.
• Bipolar Disorder: Particularly for type I and II depression phases.

The drug's utilization spans across adult and pediatric populations, with increasing awareness and diagnosis of bipolar disorder fueling demand in developed markets such as North America and Europe.

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Market Drivers

Therapeutic Efficacy and Safety Profile

Lamotrigine's favorable adverse event profile, especially a lower risk of sedation and cognitive impairment, distinguishes it from older AEDs. Its efficacy in preventing mood episodes in bipolar disorder broadens its usage spectrum [2].

Expanding Indications and Off-Label Uses

Ongoing research exploring lamotrigine in neuropathic pain, borderline personality disorder, and migraine prophylaxis could unlock additional revenue streams, contingent upon successful clinical validation.

Regulatory Approvals and Label Expansions

Regulatory authorities, including the FDA and EMA, have approved various formulations (immediate and extended-release) and pediatric indications, enhancing market penetration [3].

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Market Challenges and Constraints

Generic Competition and Price Erosion

Once patent and exclusivity periods expire, generic manufacturers enter, intensifying price competition and compressing profit margins. Generic lamotrigine accounts for the majority of prescriptions globally, exerting downward pressure on branded formulations' revenue.

Safety Concerns and Adverse Effects

Risk of severe skin reactions (e.g., Stevens-Johnson syndrome) remains a concern, necessitating careful dosing and monitoring. Such safety considerations may influence prescribing patterns.

Regulatory and Patent Litigation Risks

Patent litigations, especially concerning formulation patents, can impact market exclusivity timelines and pricing strategies.

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Competitive Landscape

Major pharmaceutical players include GlaxoSmithKline (GSK), Teva Pharmaceuticals, and Sun Pharma, which produce generic versions in addition to branded formulations. The consolidation of generic manufacturing has intensified price competition, typically leading to a stark decline in branded lamotrigine revenues upon patent expiry [4].

Innovative entities exploring novel delivery systems or combination therapies may alter the competitive landscape, but lamotrigine remains predominantly in the generic domain.

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Financial Trajectory and Revenue Projections

Historical Revenue Trends

Branded lamotrigine sales peaked in the early 2010s, but with widespread generic availability by mid-2010s, revenues declined substantially in many markets. For example, GSK's branded lamotrigine monograph sales decreased by approximately 45% between 2013 and 2018 [5].

Forecast for 2023–2030

Given the industry trend toward commoditization post-generic entry, the revenue generated from lamotrigine is expected to decline further or stabilize at lower levels unless new formulations or indications are developed.

However, in emerging markets where generic penetration is less aggressive, the drug continues to generate robust revenues. Additionally, patent protections for specific formulations or delivery mechanisms could temporarily restrain generic competition and sustain higher profit margins.

Revenue estimates:

• Developed Markets: Anticipated to experience a compound annual decline of 3-5% due to market saturation and generic competition.
• Emerging Markets: Potential growth of 4-6% driven by increasing epilepsy and bipolar disorder diagnoses, coupled with lower generic penetration.

Potential Revenue Growth Avenues

• Formulation Innovation: Extended-release or proprietary delivery systems could command premium pricing.
• New Indications: Validated off-label uses or novel approved indications may rejuvenate sales.
• Partnerships and Licensing: Collaborations with biotech firms exploring combination therapies could unlock additional revenue streams.

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Regulatory and Patent Strategies

The expiration dates of key patents significantly influence market dynamics. For lamotrigine, patent protections for specific formulations or methods of use have largely lapsed or are nearing expiry, facilitating generic entry. However, pharmaceutical companies may seek to extend exclusivity via secondary patents or formulation patents—though these are increasingly scrutinized for patent evergreening practices [6].

Regulatory agencies also impose risk management obligations, including risk evaluation and mitigation strategies (REMS), for safe prescribing, which influence market access and compliance costs.

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Future Outlook and Market Opportunities

Innovation in Drug Delivery

Development of once-daily extended-release formulations with improved tolerability could sustain higher pricing and market share.

Biomarker and Personalized Medicine Approaches

Advances in pharmacogenomics may facilitate tailored treatments, optimizing lamotrigine efficacy and safety, and potentially leading to premium products.

Expanding Global Access

Emerging markets offer significant growth opportunities due to increasing diagnoses of epilepsy and bipolar disorder, coupled with unmet treatment needs and lower generic market saturation.

Challenges to Watch

• Stringent regulatory environments may delay approvals of new formulations.
• Competitive pricing from low-cost generics diminishes profitability.
• Prescriber preference shifts towards newer agents with perceived superior efficacy or safety profiles, such as levetiracetam or carbamazepine.

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Key Takeaways

• Market Maturity and Competition: Over the past decade, lamotrigine's market in developed countries has transitioned into a mature, highly competitive landscape dominated by generics, leading to declining branded sales.

• Revenue Optimization Strategies: Innovating with new formulations, targeted indications, and strategic partnerships can offset revenue declines in matured markets.

• Emerging Market Potential: Growth opportunities in unpenetrated or underserved regions stem from increasing epilepsy and bipolar disorder prevalence and lower drug penetration.

• Regulatory Dynamics: Patent expiries and regulatory decisions shape competitive timing and pricing strategies, influencing revenue trajectories.

• Investment Implications: Companies should pivot towards innovation, emerging market expansion, and personalized medicine to maximize lamotrigine's financial potential beyond patent protection.

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FAQs

1. How does patent expiry affect lamotrigine’s market revenues?
Patent expiration leads to widespread generic manufacturing, significantly reducing branded drug prices and revenues. Companies relying on branded formulations see declining sales unless they develop new formulations or indications that extend exclusivity.

2. Are there ongoing efforts to expand lamotrigine's indications?
Yes. Research is ongoing into off-label applications like neuropathic pain and migraine prophylaxis, which could provide new revenue opportunities if supported by clinical trials and regulatory approval.

3. What role do generics play in lamotrigine’s market?
Generics dominate the market due to significant cost advantages, accounting for the majority of prescriptions globally. They exert downward pressure on prices and limit profitability for branded manufacturers.

4. Can pharmaceutical innovation revive lamotrigine's market presence?
Potentially. Innovative delivery systems, combinations with other agents, or personalized medicine approaches can command premium pricing and offset declines from generics.

5. What are the primary challenges facing lamotrigine’s future growth?
Main challenges include price erosion from generics, safety concerns (notably skin reactions), regulatory hurdles, and competition from newer agents perceived as having improved efficacy or tolerability.

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References

[1] Grand View Research. Antiepileptic Drugs Market Size, Share & Trends Analysis Report. 2022-2030.

[2] Stern, T. et al. Efficacy and safety of lamotrigine in bipolar disorder: a systematic review. J Clin Psychiatry, 2015.

[3] U.S. Food and Drug Administration. Lamictal (lamotrigine) Label. 2022.

[4] IMS Health. Global Brand and Generic Market Dynamics. 2018.

[5] GSK Annual Report. Market Performance and Revenue Trends. 2013-2018.

[6] Kesselheim, A.S. et al. Evergreening Strategies in Pharmaceutical Patents. JAMA, 2017.

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In summary, lamotrigine remains a significant player in the epilepsy and bipolar disorder treatment landscape. While market maturation and generic competition challenge its revenue potential, strategic innovation and emerging market penetration offer pathways to sustain and enhance its financial trajectory. Recognizing these dynamics enables pharmaceutical stakeholders to make informed investment and development decisions.