LAMICTAL CD Drug Patent Profile

When do Lamictal Cd patents expire, and what generic alternatives are available?

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

The generic ingredient in LAMICTAL CD 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 Cd

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

Summary for LAMICTAL CD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	95
Patent Applications:	4,481
DailyMed Link:	LAMICTAL CD at DailyMed

Recent Clinical Trials for LAMICTAL CD

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

Sponsor	Phase
Desitin Arzneimittel GmbH	PHASE1
BioPharma Services Inc.	PHASE1
Dr Cipto Mangunkusumo General Hospital	Phase 4

See all LAMICTAL CD clinical trials

Pharmacology for LAMICTAL CD

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 CD

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 CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000	AB	RX	Yes	No
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998		DISCN	No	No
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-001	Aug 24, 1998	AB	RX	Yes	No

Expired US Patents for LAMICTAL CD

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
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998

International Patents for LAMICTAL CD

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0059987	ALPHA-CYANO-ALPHA-((N-GUANIDINO)-IMINO) TOLUENES
Greece	68380
New Zealand	198159	GUANIDINE DERIVATIVES

Supplementary Protection Certificates for LAMICTAL CD

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

Market Dynamics and Financial Trajectory for LAMICTAL CD

Last updated: July 30, 2025

Introduction

LAMICTAL CD (lamotrigine controlled-release) represents a pivotal advancement within the antiepileptic drug (AED) market segment. As a long-acting formulation of lamotrigine, it offers enhanced compliance, reduced administration frequency, and potentially improved patient outcomes. Understanding the market dynamics and financial trajectory of LAMICTAL CD is critical for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers—aiming to navigate the evolving landscape of neurological disorder therapeutics.

Market Overview

Product Profile and Therapeutic Indication

LAMICTAL CD is indicated primarily for adjunctive therapy of partial seizures in adults and children. Its unique extended-release formulation allows for once-daily dosing, improving adherence compared to immediate-release counterparts. The formulation's design aims to optimize pharmacokinetics, decrease side effects, and facilitate long-term management of epilepsy, which affects approximately 50 million people globally [1].

Competitive Landscape

The AED market comprises several competitors, including brand-name drugs like Keppra (levetiracetam), Dilantin (phenytoin), and newer equivalents like Topamax (topiramate). Lamotrigine, as a first-line adjunct therapy, has a substantial footprint due to its efficacy and tolerability. LAMICTAL CD’s main competitors are immediate-release lamotrigine and other extended-release AEDs—most notably, once-daily formulations from generic markets and other branded extended-release options.

Regulatory and Market Access Environment

The drug received FDA approval primarily for epilepsy, with expanded indications in bipolar disorder in some cases. Patent exclusivity for the branded LAMICTAL CD has played a significant role in market dominance; however, expiration timelines and robust generic competition threaten revenue streams [2].

Market Dynamics

Growth Drivers

• Increasing Prevalence of Epilepsy and Bipolar Disorders: Rising global burden elevates demand. Epilepsy prevalence is estimated at 1% of the population worldwide, with incidence rates driven by aging demographics and improved diagnostic capabilities [3].

• Shift Towards Extended-Release Formulations: The convenience of once-daily dosing improves adherence and reduces adverse events, boosting adoption among both clinicians and patients.

• Expansion in Emerging Markets: Growing healthcare infrastructure and awareness in Asia-Pacific, Latin America, and Africa expand the potential patient base for LAMICTAL CD.

• Advancements in Pharmacogenomics: Personalized medicine approaches could optimize patient response, positioning LAMICTAL CD favorably due to its well-tolerated profile.

Market Challenges

• Generic Competition: Post-patent expiration, generic versions of lamotrigine significantly erode sales of branded formulations. The introduction of generic extended-release versions further intensifies competition [4].

• Pricing Pressures and Insurance Reimbursement: Healthcare payers seek cost-effective therapies, often favoring generics, which constrains premium pricing for branded LAMICTAL CD.

• Safety Profile and Adverse Events: Rare but serious adverse effects, such as Stevens-Johnson syndrome, necessitate careful monitoring, impacting clinician prescribing behavior.

• Competitive Product Pipeline: Emerging therapies within neurology, including neuromodulation devices and adjunctive drugs, could challenge the market share of LAMICTAL CD.

Financial Trajectory

Revenue Trends

Historically, LAMICTAL CD contributed significantly to the revenue streams of its manufacturer, with peak sales observed prior to patent expiry. The introduction of generics prompted a decline, with estimates suggesting a reduction of 60–70% in branded sales within two years of patent loss [5].

Revenue Forecasting

Forecasts indicate a continued decline in branded LAMICTAL CD revenue in the next 3–5 years, aligning with the proliferation of generics. However, strategic measures like lifecycle management, new patent filings, or combination therapies may stabilize or prolong revenue streams.

Strategic Responses

• Innovation and Line Extensions: Developing formulations with improved delivery mechanisms or dosing options.
• Market Differentiation: Emphasizing unique pharmacokinetic profiles and clinical benefits.
• Expansion into Adjacent Indications: Leveraging existing safety profiles for bipolar disorder or off-label uses.

Merger and Acquisition Activity

Large pharmaceutical firms may acquire or license competing drugs or research programs to sustain growth, particularly as revenues from branded LAMICTAL CD diminish.

Future Outlook and Opportunities

Emerging Market Penetration

Growth opportunities persist in regions with expanding epilepsy awareness and infrastructure. Tailored pricing strategies and local partnerships could bolster sales.

Pharmacogenomic Tailoring

Personalized treatments could enhance efficacy, reduce adverse events, and justify premium pricing of future formulations or combination therapies.

Digital Health Integration

Remote monitoring and adherence tools may enhance treatment outcomes, create value propositions, and support premium pricing models for innovative formulations.

Investment in Pipeline Development

Partnerships or licensing agreements targeting next-generation AEDs or adjunctive therapies could generate sustainable revenue streams.

Conclusion

The market dynamics and financial trajectory of LAMICTAL CD reflect a complex interplay of innovation, competition, regulatory environments, and shifting healthcare paradigms. While patent expiry and generics dampen revenue potential in the short term, strategic innovation and expanding indications could offer avenues for growth. Stakeholders must navigate these currents with agility, leveraging market insights to make informed investment and clinical decisions.

Key Takeaways

• Patent expiries have significantly impacted branded LAMICTAL CD revenues; strategic lifecycle management remains critical.
• Generic competition is the primary market disruptor, necessitating innovation and differentiation strategies.
• Emerging markets present growth opportunities due to increasing epilepsy prevalence and healthcare infrastructure development.
• Personalized medicine and digital health integrations can enhance treatment efficacy and capitalize on new revenue streams.
• Future success hinges on adaptability, including development of new formulations, expansion into new indications, and strategic partnerships.

FAQs

1. What factors initially contributed to the market success of LAMICTAL CD?
   Its once-daily extended-release formulation improved adherence, and clinical efficacy in epilepsy and bipolar disorder established its reputation among clinicians and patients.

2. How does patent expiry influence the financial trajectory of LAMICTAL CD?
   Patent expiration enables generic competitors to enter the market, significantly reducing revenue from branded formulations due to price competition.

3. What strategies can manufacturers employ to sustain revenues for LAMICTAL CD?
   Innovation in formulations, expanding indications, engaging in lifecycle management, and entering emerging markets can offset revenue declines.

4. What role does regional market expansion play in the future outlook of LAMICTAL CD?
   It offers growth potential amidst mature markets, particularly where epilepsy diagnosis and treatment infrastructure are developing.

5. Are there promising pipeline developments related to lamotrigine?
   Research into combination therapies and new delivery mechanisms continues, although no major pipeline breakthroughs currently outpace generic threats.

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Sources:

[1] World Health Organization. (2022). Epilepsy factsheet.
[2] U.S. Food and Drug Administration. (2020). FDA Approvals and Patent Status Reports.
[3] Ngugi, A. K., et al. (2019). Global burden of epilepsy. The Lancet.
[4] IQVIA. (2021). Market Share and Generic Entry Trends in AEDs.
[5] PhRMA. (2022). Impact of Patent Expiry on Pharmaceutical Revenues.