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Drug Price Trends for NDC 00115-9942
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Average Pharmacy Cost for 00115-9942
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LAMOTRIGINE ODT 200 MG TABLET | 00115-9942-01 | 3.18951 | EACH | 2025-04-23 |
| LAMOTRIGINE ODT 200 MG TABLET | 00115-9942-01 | 2.77446 | EACH | 2025-04-09 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00115-9942
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Lamotrigine ODT (NDC 00115-9942)
Lamotrigine, a cornerstone in the treatment of epilepsy and bipolar disorder, has seen evolving market dynamics with the introduction of specialized formulations like orally disintegrating tablets (ODTs). The NDC 00115-9942, produced by Amneal Pharmaceuticals of New York LLC, represents a critical innovation in patient-centric drug delivery. This report examines the current market landscape, growth drivers, and price trajectories for this formulation, offering insights into its strategic position within the broader pharmaceutical sector.
Global Lamotrigine Market Overview
Current Market Valuation and Growth Trajectory
The global lamotrigine market was valued at approximately $1.2 billion in 2022, with projections suggesting a compound annual growth rate (CAGR) of 10.1% through 2030, reaching $2.5 billion[6]. Alternative analyses estimate a slightly moderated CAGR of 5.00% from 2024 to 2031, reflecting regional disparities and formulation-specific demand[5]. These growth figures underscore the drug’s entrenched role in managing neurological and mood disorders, particularly amid rising global prevalence rates of epilepsy (affecting over 50 million worldwide) and bipolar disorder (impacting nearly 2.8% of U.S. adults)[6][11].
Regional Market Dynamics
- North America: Dominates with 40% market share, driven by high diagnosis rates and robust healthcare infrastructure. The region is expected to grow at a CAGR of 3.2% through 2031[5][12].
- Europe: Accounts for 30% of global revenue, bolstered by mental health initiatives and aging populations. Projected CAGR stands at 3.5%[5].
- Asia-Pacific: The fastest-growing region (7.0% CAGR), attributed to expanding healthcare access and a rising pediatric epilepsy burden[5][12].
Lamotrigine ODT (NDC 00115-9942): Formulation-Specific Analysis
Product Differentiation and Therapeutic Advantages
The ODT formulation addresses critical patient needs, particularly in populations with dysphagia (difficulty swallowing), which affects up to 35% of elderly patients[8]. By eliminating the need for water and enabling rapid dissolution, ODTs enhance adherence—a key factor in chronic disease management. Clinical studies indicate that improved compliance correlates with a 20–30% reduction in seizure recurrence and mood episode severity[11].
Current Pricing and Cost Structure
As of April 2025, the cash price for NDC 00115-9942 (200 mg ODT) is $2.77 per tablet, significantly higher than conventional lamotrigine tablets (e.g., $0.74 per 100 mg tablet)[13]. This premium reflects manufacturing complexities, patent protections, and targeted marketing to niche patient segments. For uninsured patients, a 30-tablet pack costs approximately $83.10, though manufacturer coupons and Medicaid programs can reduce out-of-pocket expenses to as low as $5 per prescription[11][13].
Market Drivers and Challenges
Key Growth Drivers
- Mental Health Awareness: Global campaigns have increased bipolar disorder diagnoses by 18% since 2020, expanding the eligible patient pool[12].
- Aging Demographics: With 16% of the global population over 65 by 2030, age-related neurological conditions will drive demand[5].
- Regulatory Support: FDA guidelines prioritizing ODT quality standards (e.g., disintegration time <30 seconds) have bolstered clinician confidence[8].
Operational Challenges
- Generic Competition: Generics occupy 80% of the lamotrigine market, pressuring branded formulations to justify premium pricing through differentiated value[11].
- Supply Chain Vulnerabilities: API (active pharmaceutical ingredient) shortages, particularly post-COVID-19, caused 15–20% price volatility in 2023–2024[5].
- Reimbursement Hurdles: Insurers increasingly demand comparative effectiveness data for ODTs versus conventional tablets, delaying formulary inclusions[8].
Price Projections and Influencing Factors
Short-Term Outlook (2025–2027)
ODT prices are expected to stabilize near $2.50–$3.00 per tablet, supported by limited generic competition and sustained demand from pediatric/geriatric cohorts. However, the anticipated 2026 patent expiration for Amneal’s ODT may invite generics, potentially reducing prices by 10–15%[13].
Long-Term Trends (2028–2033)
By 2030, the lamotrigine ODT segment is projected to capture 25–30% of the total market, up from 18% in 2024[12]. Price erosion will accelerate post-2027 as generics penetrate, driving average costs down to $1.80–$2.20 per tablet. Concurrently, value-based pricing models—tying reimbursement to seizure-free periods or mood stability—may emerge, favoring formulations with demonstrable adherence benefits[8].
External Influences
= Policy Changes: Proposed U.S. legislation capping annual drug price increases at CPI + 2%** could constrain pricing flexibility[2].
- Technological Integration: AI-driven adherence monitoring tools (e.g., smart blister packs) may justify premium pricing by linking ODT use to improved outcomes[10].
Strategic Recommendations for Stakeholders
For Manufacturers
- Invest in Lifecycle Management: Develop combination therapies (e.g., lamotrigine + digital adherence tools) to differentiate ODTs post-genericization.
- Expand Indications: Pursue FDA approvals for off-label uses (e.g., migraines, neuropathic pain) to tap into adjacent markets[5].
For Healthcare Providers
- Prioritize Patient Education: Highlight ODTs’ ease of use in caregiver and patient counseling sessions to drive adoption.
- Leverage Real-World Evidence: Collaborate on post-marketing studies demonstrating ODTs’ cost-effectiveness via reduced hospitalizations.
For Payers
- Develop Tiered Formularies: Place ODTs in preferred tiers for high-risk populations (e.g., elderly with dysphagia) while maintaining generics as first-line.
- Implement Outcomes-Based Contracts: Tie reimbursements to measurable adherence metrics, sharing risk with manufacturers.
Conclusion
The lamotrigine ODT market, epitomized by NDC 00115-9942, sits at the intersection of therapeutic innovation and evolving healthcare economics. While generic pressures loom, the formulation’s unique value in enhancing adherence positions it for sustained growth, particularly in aging and pediatric demographics. Stakeholders must navigate regulatory, competitive, and technological shifts to capitalize on this niche yet vital segment.
“The future of neurology lies in formulations that respect patient lifestyles while delivering uncompromised efficacy.”
— Cognitive Market Research, 2025[5]
References
- https://fda.report/NDC/0115-1487
- https://www.drugpatentwatch.com/p/drug-price/ndc/00143-9431
- https://www.findacode.com/ndc/labelers/Amneal_Pharmaceuticals_of_New_York_LLC--00115
- https://ndclist.com/ndc/64850-504
- https://www.cognitivemarketresearch.com/lamotrigine-market-report
- https://www.verifiedmarketreports.com/product/lamotrigine-market/
- https://www.globenewswire.com/news-release/2024/02/20/2831955/0/en/Global-Incretin-Based-Drugs-Market-Report-2023-2029-with-Analysis-of-Leading-Market-Players-like-Eli-Lilly-and-Co-Boehringer-Ingelheim-Novo-Nordisk-and-AstraZeneca-Among-Others.html
- https://www.drugpatentwatch.com/p/drug-price/drugname/index.php?query=LAMOTRIGINE+ODT+KIT+%28ORANGE%29
- https://www.drugpatentwatch.com/p/drug-price/drugname/index.php?query=ZOLPIDEM+TARTRATE
- https://www.drugpatentwatch.com/p/drug-price/ndc/00115-1701
- https://www.singlecare.com/blog/lamotrigine-without-insurance/
- https://github.com/hurstsaqibyl/Market-Research-Report-List-1/blob/main/lamotrigine-market.md
- https://www.drugpatentwatch.com/p/drug-price/drugname/index.php?query=LAMOTRIGINE
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