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 five branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, 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-five NDAs. There is one patent 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-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for lamotrigine

International Patents:	44
US Patents:	1
Tradenames:	5
Applicants:	41
NDAs:	55
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	210
Patent Applications:	6,918
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
Mental Health Services in the Capital Region, Denmark	Phase 4
Dr. Inge Winter	Phase 4
Westfälische Wilhelms-Universität Münster	Phase 4

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
Actavis Elizabeth	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672-004	Oct 17, 2013	AB	RX	No	No
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-004	May 8, 2009	AB	RX	Yes	No
Dr Reddys Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	202383-002	Jun 19, 2013	AB	RX	No	No

Expired US Patents for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-001	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-001	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998

International Patents for lamotrigine

Country	Patent Number	Title	Estimated Expiration
Canada	2493301	FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE (SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE)
Hong Kong	1077003	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE
New Zealand	537885	Sustained release formulations comprising a lamotrigine core and an outer coating

Lamotrigine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lamotrigine

Introduction to Lamotrigine

Lamotrigine, commonly known by the brand name Lamictal, is a prescription medication used primarily to treat epilepsy and bipolar disorder. It has been a staple in the pharmaceutical industry for its efficacy in managing neurological and mood disorders.

Global Market Size and Growth

The global lamotrigine market is projected to experience significant growth over the next several years. As of 2024, the market size is estimated to be in the millions of USD, with a compound annual growth rate (CAGR) of 5.00% anticipated from 2024 to 2031[1][4].

Regional Market Analysis

North America

North America holds a substantial share of the global lamotrigine market, accounting for around 40% of the global revenue. The region's robust healthcare infrastructure, high diagnosis rates, and favorable reimbursement policies contribute to the growth. The aging population and increasing mental health awareness also drive demand for lamotrigine, particularly in hospital pharmacies[1].

Europe

Europe accounts for approximately 30% of the global revenue and is expected to grow at a CAGR of 3.5% from 2024 to 2031. The region's expanding healthcare expenditure, initiatives promoting mental health awareness, and the presence of leading pharmaceutical companies are key drivers. Hospital pharmacies in Europe hold a major market share due to their established distribution networks and trusted relationships with healthcare providers[1].

Asia Pacific

The Asia Pacific region is poised for significant growth, with a CAGR of 7.0% from 2024 to 2031. This growth is driven by rising healthcare expenditure, improving access to healthcare services, and growing awareness campaigns about neurological and mood disorders. The region's large pediatric population, particularly in the segment of pediatric epilepsy, further contributes to the demand for lamotrigine[1].

Latin America

Latin America accounts for around 5% of the global revenue and is expected to grow at a CAGR of 4.4% from 2024 to 2031. The expansion of healthcare infrastructure, increasing urbanization, and rising awareness about mental health are key factors driving growth. Partnerships between pharmaceutical companies and healthcare organizations also enhance market penetration in this region[1].

Middle East and Africa

The Middle East and Africa region holds a smaller but growing share of the market, with a CAGR of 4.7% from 2024 to 2031. Improving healthcare infrastructure, rising healthcare spending, and increasing awareness about neurological disorders contribute to the growth. Partnerships between pharmaceutical companies and local healthcare providers also play a crucial role[1].

Efficacy and Clinical Use

Lamotrigine has established efficacy in treating epilepsy and bipolar disorder. It is approved for various indications, including conversion to monotherapy in patients receiving treatment with a single antiepileptic drug (AED), adjunctive treatment for partial seizures, and long-term management of mood episodes in bipolar I disorder[2].

Generic and Brand-Name Dynamics

The availability of generic lamotrigine has significantly impacted the market. Generic versions are considered as safe and effective as the brand-name medication but are generally less expensive. This is due to the lack of extensive research and testing required for generic drugs, which reduces their cost. The FDA has confirmed the bioequivalence of generic lamotrigine extended-release tablets to the brand-name product, ensuring that patients can switch between the two without clinical concerns[3][5].

Cost and Affordability

The cost of lamotrigine can vary based on factors such as dosage, insurance coverage, and the pharmacy used. For patients without insurance, the cost is typically higher. However, using coupons, mail-order pharmacies, and opting for a 90-day supply can help reduce costs. Medicare coverage for lamotrigine also varies depending on the specific plan, and prior authorization may be required[5].

Market Drivers

• Healthcare Infrastructure: Robust healthcare infrastructure in regions like North America and Europe supports the growth of the lamotrigine market.
• Mental Health Awareness: Increasing awareness about neurological and mood disorders drives treatment-seeking behavior among patients.
• Reimbursement Policies: Favorable reimbursement policies and insurance coverage enhance affordability and accessibility.
• Aging Population: The aging population in various regions contributes to the demand for treatments targeting neurological and mood disorders.
• Pharmaceutical Innovations: The presence of leading pharmaceutical companies and advancements in telemedicine and e-prescription systems facilitate market growth.

Market Challenges

• Regulatory Standards: Stringent regulatory standards, while ensuring safety and quality, can pose challenges for new market entrants.
• Generic Competition: The availability of generic versions can reduce the market share of brand-name medications.
• Geographical Variations: Differences in healthcare infrastructure and awareness levels across regions can affect market penetration.

Financial Trajectory

The financial trajectory of lamotrigine is positive, driven by the growing demand for effective treatments for epilepsy and bipolar disorder. The projected CAGR of 5.00% to 5.67% from 2024 to 2031 indicates a steady and significant growth in revenue. The expansion into new markets, particularly in the Asia Pacific region, and the increasing adoption of generic versions are expected to contribute to this growth[1][4].

Key Takeaways

• The global lamotrigine market is expected to grow at a CAGR of 5.00% to 5.67% from 2024 to 2031.
• North America, Europe, and the Asia Pacific are key regions driving market growth.
• Generic versions of lamotrigine are bioequivalent to brand-name products and offer a cost-effective alternative.
• Favorable reimbursement policies, mental health awareness, and robust healthcare infrastructure are significant market drivers.
• The aging population and advancements in healthcare technology also contribute to the market's financial trajectory.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of lamotrigine? A: Lamotrigine is primarily used to treat epilepsy and bipolar disorder, including indications such as conversion to monotherapy, adjunctive treatment for partial seizures, and long-term management of mood episodes in bipolar I disorder[2].

Q: How does the cost of lamotrigine vary? A: The cost of lamotrigine varies based on factors such as dosage, insurance coverage, and the pharmacy used. Generic versions are generally less expensive than brand-name medications[5].

Q: Is generic lamotrigine as effective as the brand-name version? A: Yes, generic lamotrigine extended-release tablets have been shown to be bioequivalent to the brand-name product, ensuring they are as safe and effective[3].

Q: What regions are driving the growth of the lamotrigine market? A: North America, Europe, and the Asia Pacific are the key regions driving the growth of the lamotrigine market, each with unique drivers such as robust healthcare infrastructure, increasing awareness, and expanding healthcare expenditure[1].

Q: How can patients reduce the cost of lamotrigine? A: Patients can reduce the cost of lamotrigine by using coupons, opting for a 90-day supply, using mail-order pharmacies, and checking with their insurance providers for coverage details[5].

Sources Cited:

1. Cognitive Market Research - Lamotrigine Market Report
2. FDA - Lamotrigine Clinical PREA
3. FDA - Generic Lamotrigine Extended-Release Tablets Bioequivalence
4. Absolute Reports - Global Lamotrigine Market
5. Healthline - Lamotrigine Cost 2024: Coupons and More