LAMICTAL XR Drug Patent Profile

When do Lamictal Xr patents expire, and when can generic versions of Lamictal Xr launch?

Lamictal Xr is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in thirty countries.

The generic ingredient in LAMICTAL XR 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 Xr

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

Summary for LAMICTAL XR

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	94
Patent Applications:	4,991
Drug Prices:	Drug price information for LAMICTAL XR
Drug Sales Revenues:	Drug sales revenues for LAMICTAL XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAMICTAL XR
DailyMed Link:	LAMICTAL XR at DailyMed

See drug prices for LAMICTAL XR

See drug sales revenues for LAMICTAL XR

Recent Clinical Trials for LAMICTAL XR

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 XR clinical trials

Pharmacology for LAMICTAL XR

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

Paragraph IV (Patent) Challenges for LAMICTAL XR

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

US Patents and Regulatory Information for LAMICTAL XR

LAMICTAL XR is protected by one US patents.

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 XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	AB	RX	Yes	No	8,637,512		Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	AB	RX	Yes	Yes	8,637,512		Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-002	May 29, 2009	AB	RX	Yes	Yes	8,637,512		Y

Expired US Patents for LAMICTAL XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-003	May 29, 2009	9,144,547
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	9,144,547
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	9,144,547

International Patents for LAMICTAL XR

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

Country	Patent Number	Title	Estimated Expiration
Uruguay	27660	NUEVA COMPOSICIÓN
Norway	334453
Taiwan	I286079

Market Dynamics and Financial Trajectory for LAMICTAL XR

Introduction

LAMICTAL XR, the extended-release formulation of lamotrigine, is a crucial antiepileptic medication used for the treatment of various seizure types and mood disorders. Understanding the market dynamics and financial trajectory of this drug is essential for stakeholders, including patients, healthcare providers, and pharmaceutical companies.

Market Indications and Usage

LAMICTAL XR is indicated for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. It is also approved for conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with a single antiepileptic drug[2].

Competitive Landscape

The antiepileptic drug market is highly competitive, with several brands and generics available. The approval of generic lamotrigine extended-release tablets has significantly impacted the market dynamics. Generic versions have been shown to be bioequivalent to the brand-name LAMICTAL XR, making them a cost-effective alternative. This has increased accessibility and reduced costs for patients, thereby expanding the market reach[4].

Financial Considerations

Cost and Affordability

The cost of LAMICTAL XR can be a significant burden for many patients. However, various patient assistance programs and discount plans are available to help mitigate these costs. For instance, programs like The Rx Advocates offer monthly service fees starting at $80 for patients needing financial assistance with their medication[5].

Revenue and Market Share

The introduction of generic versions has led to a shift in market share. While the brand-name LAMICTAL XR still maintains a significant market presence due to its established reputation and patient loyalty, generic alternatives are gaining ground. This competition has driven down prices, making the medication more affordable but potentially reducing the revenue for the innovator company.

Regulatory Environment

The FDA plays a critical role in the market dynamics of LAMICTAL XR through its regulatory actions. The approval process for both the brand and generic versions involves rigorous clinical trials and pharmacokinetic studies to ensure safety and efficacy. For example, the FDA conducted a fully replicated crossover bioequivalence study to confirm the bioequivalence of generic lamotrigine extended-release tablets to the brand-name product[4].

Risk-Benefit Assessment

The use of LAMICTAL XR comes with a well-defined risk profile, including the potential for serious skin rashes and other adverse effects. However, the benefit of effective seizure control and the extensive clinical use record outweigh these risks. Regulatory measures such as comprehensive labeling, Medguides, and pharmacovigilance plans are in place to manage these risks[1].

Clinical Efficacy and Safety

Clinical trials, such as Study LAM10036 and Study 34, have demonstrated the efficacy of LAMICTAL XR in reducing seizure frequency. These studies showed statistically significant reductions in seizure rates compared to placebo, with a median percent reduction in weekly seizures of up to 47% for XR lamotrigine[1][3].

Impact of Concomitant Medications

The dosing regimen of LAMICTAL XR can be influenced by concomitant medications, particularly those that induce or inhibit lamotrigine glucuronidation. Adjustments in the maintenance dose may be necessary when patients are taking estrogen-containing oral contraceptives or other drugs that affect lamotrigine plasma levels[2].

Patient Assistance and Access Programs

To improve accessibility, various patient assistance programs are available. These programs offer discounts, copay cards, and savings plans to help patients afford their medication. For instance, The Rx Advocates provides a structured pricing model with monthly fees starting at $80, making it more manageable for patients to continue their treatment[5].

Generic Substitution and Bioequivalence

The FDA's confirmation of bioequivalence between generic and brand-name lamotrigine extended-release tablets has reassured healthcare providers and patients about the safety and efficacy of generic substitutions. This has led to increased confidence in switching from brand to generic, further expanding market accessibility[4].

Financial Projections and Market Trends

Given the competitive landscape and the increasing availability of generic alternatives, the financial trajectory for LAMICTAL XR is likely to involve a gradual decline in revenue for the brand-name product. However, the overall market for lamotrigine extended-release formulations is expected to remain stable due to the ongoing demand for effective antiepileptic medications.

Key Takeaways

• Market Indications: LAMICTAL XR is used for adjunctive therapy in various seizure types and for conversion to monotherapy.
• Competitive Landscape: Generic versions are increasingly available, impacting market dynamics and costs.
• Financial Considerations: Patient assistance programs and generic alternatives help reduce costs.
• Regulatory Environment: FDA approvals and bioequivalence studies ensure safety and efficacy.
• Risk-Benefit Assessment: Effective seizure control outweighs the risks of adverse effects.
• Clinical Efficacy: Statistically significant reductions in seizure rates have been demonstrated.
• Impact of Concomitant Medications: Dose adjustments may be necessary based on other medications.
• Patient Assistance Programs: Various programs help improve accessibility and affordability.

FAQs

What is LAMICTAL XR used for?

LAMICTAL XR is used as adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. It is also used for conversion to monotherapy in patients with partial-onset seizures[2].

What are the potential risks associated with LAMICTAL XR?

The primary risks include serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, as well as other adverse effects like dizziness, ataxia, and diplopia[1][2].

How do generic versions of lamotrigine extended-release tablets compare to the brand-name LAMICTAL XR?

Generic versions have been shown to be bioequivalent to LAMICTAL XR, meaning they have comparable peak serum concentrations and overall exposure. This makes them a safe and cost-effective alternative[4].

What patient assistance programs are available for LAMICTAL XR?

Programs like The Rx Advocates offer monthly service fees starting at $80 to help patients afford their medication. Other programs include copay cards and savings plans[5].

How does the use of concomitant medications affect the dosing of LAMICTAL XR?

Concomitant medications that induce or inhibit lamotrigine glucuronidation may require adjustments in the maintenance dose of LAMICTAL XR to maintain consistent plasma levels[2].

Cited Sources

1. FDA Clinical Review: Lamictal XR/lamotrigine XR Clinical Review - FDA[1]
2. Prescribing Information: LAMICTAL XR (lamotrigine) extended-release tablets, for oral use[2]
3. FDA Clinical Review: 22-115s000 - accessdata.fda.gov[3]
4. FDA Regulatory Science Action: FDA shows generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study[4]
5. The Rx Advocates: Lamictal XR Coupon & Assistance Programs – Cost $80/month[5]

Last updated: 2024-12-17