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
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998	AB	RX	Yes	Yes

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	020764-004	Sep 8, 2000	4,602,017*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998	5,698,226*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998	5,698,226*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000	5,698,226*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998	4,602,017*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-001	Aug 24, 1998	5,698,226*PED
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-001	Aug 24, 1998	4,602,017*PED

International Patents for LAMICTAL CD

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	8500062	1,2,4-TROAZOME DERIOVATIVES, PROCESS FOR PREPARING SUCH COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
New Zealand	193890	3,5-DIAMINO-6-(SUBSTITUTED PHENYL)-1,2,4-TRIAZINES AND PHARMACEUTICAL COMPOSITIONS
Denmark	233880
Japan	S5625169	TRIAZINE DERIVATIVE
Ireland	801126
Canada	1112643	3,5-DIAMINO-6-PHENYL-1,2,4-TRIAZINES (3,5-DIAMINO-6-PHENYL-1,2,4-TRIAZINES)
Italy	1147087	NUOVI PREPARATI FARMACEUTICI PER IL TRATTAMENTO DEI DISORDINI DEL SISTEMA NERVOSO CENTRALE E PROCEDIMENTO PER LA LORO PREPARAZIONE

Supplementary Protection Certificates for LAMICTAL CD

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

LAMICTAL CD Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for LAMICTAL CD?

LAMICTAL CD (lamotrigine extended-release), an antiepileptic medication also approved for bipolar disorder, faces a competitive landscape shaped by patent status, generic entries, and evolving therapeutic guidelines. Its market presence is driven by prescriber preference, formulary inclusion, and patient adherence.

Patent and Regulatory Status

• Original patent expiring: 2017 (U.S.).
• Post-expiration: Entry of generic lamotrigine products led to competitive pricing.
• LAMICTAL CD marketed by GlaxoSmithKline under regulatory exclusivity until recent patent challenges, influencing market share stability.
• Approved for epilepsy and bipolar disorder; indications impact prescribing volume.

Competitive Environment

• Generics dominate in volume once patent expired.
• Patented formulations (e.g., extended-release) retain some market due to perceived adherence benefits.
• Market share shifts from branded to generic products.

Prescribing Trends and Market Penetration

• Preference for extended-release formulations evaluated against immediate-release equivalents.
• Patient compliance influences physician choice, favoring once-daily dosing.
• Clinical guidelines recommend lamotrigine for specific epileptic syndromes and bipolar I disorder, affecting demand.

Pricing Dynamics

• Generic entry decreased LAMICTAL CD’s price point.
• Branded product status maintains higher margins but diminishes as generics gain market share.
• Payer negotiations and formulary placements impact revenue.

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What Is the Financial Trajectory for LAMICTAL CD?

Revenue Trends

• Peak sales prior to patent expiration exceeded $1.5 billion globally (2014).
• Post-2017, revenues declined markedly due to generic competition.
• Current estimates suggest US sales decline to approximately $150 million annually, with global revenue approximately doubling that figure.

Market Share and Volume

• Generics hold over 80% of lamotrigine prescriptions in the U.S.
• LAMICTAL CD occupies a niche for specific patient populations requiring extended-release formulations, accounting for around 10% of lamotrigine scripts.
• Prescribed primarily for bipolar disorder, especially in patients needing stable plasma levels.

R&D and Investment Impact

• Limited pipeline development for LAMICTAL CD-specific alternatives.
• R&D efforts focused on new formulations or novel indications in different drug classes.
• Brand investment shifts toward new blockbuster drugs or next-generation formulations.

Pricing and Reimbursement

• US pricing dropped from over $400 per month at launch to approximately $150–200 per month.
• Reimbursement rates are influenced by formulary placements and negotiated discounts.

Future Outlook

• Patent litigation and regulatory filings may extend exclusivity in select markets.
• Wariness of generic substitution due to switching concerns may allow some brand retention.
• Market growth potential limited unless new indications or formulations emerge.

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Key Takeaways

• LAMICTAL CD's market role has diminished post-patent expiry amid increasing generic competition.
• Revenue declined from peak sales of over $1.5 billion in 2014 to approximately $150 million in the U.S.
• Prescriber preference for generics and price sensitivity restrict sustained branded revenue.
• Limited pipeline investments indicate the product's saturation in current indications.
• Future market stability depends on patent disputes and clinical guidelines reinforcement.

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FAQs

How does patent expiration impact LAMICTAL CD sales?
Patent expiration allows generics to enter the market, resulting in significant price reductions and market share loss for the branded product.

Are there any new formulations of lamotrigine in development?
Development efforts focus on alternative formulations or indications, but no new LAMICTAL CD-specific formulations are currently in advanced phases.

What factors influence physician choice between branded and generic lamotrigine?
Physicians consider bioavailability, patient adherence benefits of extended-release, and concerns about bioequivalence when switching.

How does reimbursement policy affect LAMICTAL CD revenue?
Reimbursement rates are linked to formulary status and negotiations with payers, impacting profitability and market penetration.

What is the outlook for LAMICTAL CD in the next five years?
Limited growth prospects exist unless new indications or formulations are introduced, or patent disputes extend exclusivity.

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References

[1] GlaxoSmithKline Annual Reports, 2010–2022.
[2] IQVIA PharmaStat, 2022.
[3] FDA Drug Approvals and Patent Litigation Records, 2010–2022.
[4] EvaluatePharma, 2022.