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-two 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:	150
Clinical Trials:	94
Patent Applications:	4,333
DailyMed Link:	LAMICTAL CD at DailyMed

Recent Clinical Trials for LAMICTAL CD

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Brown University	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

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	020764-002	Aug 24, 1998	4,602,017*PED
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	020764-003	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
Denmark	153787
Germany	3071000
Australia	530999

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 Experimental

Market Dynamics and Financial Trajectory for LAMICTAL CD

Introduction

LAMICTAL CD, a formulation of the antiepileptic drug lamotrigine, has been a significant player in the pharmaceutical market since its approval by the FDA in 1998. Here, we will delve into the market dynamics and financial trajectory of LAMICTAL CD, exploring its indications, market competition, pricing, and the impact of generic availability.

Indications and Uses

LAMICTAL CD is indicated for the treatment of epilepsy and as a mood stabilizer in bipolar disorder. Specifically, it is used for:

• Conversion to monotherapy in adults with partial-onset seizures who are receiving treatment with certain antiepileptic drugs (AEDs)[3].
• Maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes[3].

Market Competition

The market for antiepileptic drugs is highly competitive, with several other medications available for similar indications. However, LAMICTAL CD has maintained a strong position due to its efficacy and safety profile.

Brand vs. Generic

The original patent for LAMICTAL CD held by GlaxoSmithKline LLC has expired, allowing for the entry of generic versions of lamotrigine. This has increased competition and affected the financial trajectory of the brand-name drug. Generic versions are available in various formulations, including tablets for oral suspension, which directly compete with LAMICTAL CD[1].

Pricing and Revenue

The pricing of LAMICTAL CD has been a critical factor in its market dynamics. Initially, as a brand-name drug, it commanded a premium price. However, with the introduction of generic alternatives, the pricing strategy has had to adapt.

Impact of Generic Availability

The availability of generic lamotrigine has significantly reduced the revenue generated by LAMICTAL CD. Generic drugs are typically priced lower than their brand-name counterparts, leading to a shift in market share. This has forced GlaxoSmithKline to adjust its pricing and marketing strategies to maintain market share.

Financial Trajectory

The financial performance of LAMICTAL CD has seen a decline since the introduction of generic versions.

Peak Sales

LAMICTAL CD reached its peak sales in the early 2000s, before the patent expiration. During this period, it was one of the leading antiepileptic drugs on the market.

Post-Patent Expiration

After the patent expired, the sales of LAMICTAL CD began to decline. Generic versions captured a significant portion of the market, reducing the brand-name drug's revenue. This decline is typical for pharmaceuticals post-patent expiration.

Regulatory and Safety Considerations

Regulatory actions and safety concerns have also influenced the financial trajectory of LAMICTAL CD.

FDA Warnings

The FDA has issued a black box warning for LAMICTAL due to severe skin rashes and adverse autoimmune and allergic reactions. This warning, while necessary for patient safety, can impact prescribing habits and patient confidence, further affecting sales[5].

Clinical Studies and Efficacy

Despite safety concerns, clinical studies have consistently shown the efficacy of lamotrigine in treating epilepsy and bipolar disorder. For example, studies on Lamictal XR (an extended-release formulation) demonstrated statistically significant reductions in primary generalized tonic-clonic seizures compared to placebo[2].

Market Trends and Future Outlook

The market for antiepileptic drugs continues to evolve, driven by advancements in medical research and changes in patient needs.

Emerging Therapies

New therapies and formulations are being developed, which could further compete with LAMICTAL CD. However, lamotrigine's established efficacy and safety profile ensure it remains a viable option for many patients.

Patient and Physician Preferences

Patient and physician preferences also play a crucial role. Some patients and healthcare providers may prefer the brand-name drug due to its established reputation and patient support programs offered by GlaxoSmithKline.

Key Takeaways

• Generic Competition: The introduction of generic lamotrigine has significantly impacted the sales and revenue of LAMICTAL CD.
• Regulatory Considerations: FDA warnings and safety concerns have influenced prescribing habits and patient confidence.
• Efficacy and Safety: Clinical studies continue to support the efficacy of lamotrigine, despite safety concerns.
• Market Trends: The market is evolving with new therapies and formulations, but LAMICTAL CD remains a relevant treatment option.

FAQs

What is LAMICTAL CD used for?

LAMICTAL CD is used for the treatment of epilepsy and as a mood stabilizer in bipolar disorder.

How has the introduction of generic lamotrigine affected LAMICTAL CD?

The introduction of generic lamotrigine has led to a significant decline in the sales and revenue of LAMICTAL CD due to lower pricing and increased competition.

What are the safety concerns associated with LAMICTAL CD?

LAMICTAL CD carries a black box warning for severe skin rashes and adverse autoimmune and allergic reactions, including conditions like Hemophagocytic Lymphohistiocytosis (HLH)[5].

How does the use of estrogen-containing oral contraceptives affect LAMICTAL CD dosing?

Estrogen-containing oral contraceptives can increase the clearance of lamotrigine, requiring dose adjustments to maintain consistent plasma levels[3].

What is the impact of enzyme-inducing antiepileptic drugs on lamotrigine?

Enzyme-inducing antiepileptic drugs like carbamazepine, phenytoin, and phenobarbital can decrease the half-life of lamotrigine, necessitating dose adjustments[4].

Sources

1. Generic Lamictal CD Availability - Drugs.com
2. Lamictal XR/lamotrigine XR Clinical Review - FDA
3. LAMICTAL (lamotrigine) tablets, for oral use - FDA
4. Lamotrigine: Uses, Interactions, Mechanism of Action - DrugBank
5. Sandy Springs Lamictal Lawsuit Attorney - Ashenden & Associates