Last updated: February 27, 2026
What is NDC 49348-0190?
NDC 49348-0190 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on available data, this code corresponds to Firdapse (amifampridine) 3 mg tablets, used primarily in the treatment of Lambert-Eaton myasthenic syndrome (LEMS).
Market Size and Adoption
Approved Indications and Patient Population
Firdapse (amifampridine) was approved by the FDA in 2018 (reviewed under NDA 210736). The medication is indicated for LEMS, a rare neuromuscular disorder with an estimated prevalence of 3 to 4 cases per million.
Market Entry
Johnson & Johnson’s Janssen Pharmaceuticals markets Firdapse. The company entered the market following the Orphan Drug Act incentives, leading to exclusive marketing rights until 2028. The rare disease status limits the total potential patient population to approximately 1,300-1,700 US patients based on prevalence estimates.
Market Dynamics
- Therapeutic Profile: Firdapse is a first-line treatment for LEMS with relatively few competitors, mainly off-label uses.
- Physician Adoption: Given its specificity, the drug has limited prescribing patterns, possibly reaching fewer than 5,000 prescriptions annually across the US.
- Pricing: The drug’s high price point constrains accessibility, influencing market size.
Pricing Structure and Revenue Estimates
Wholesale Acquisition Cost (WAC)
As of 2023, the WAC for Firdapse 3 mg tablets is approximately $35 per tablet. This equates to:
| Dosage |
Cost per Tablet |
Monthly Cost (assuming 60 mg daily) |
Annual Cost (assuming 60 mg daily) |
| 3 mg |
$35 |
$2,100 |
$25,200 |
Note: Typical dosing ranges from 30-60 mg daily, divided into multiple doses.
Revenue Projections
Assumptions:
- Patient Population: 1,500 diagnosed patients.
- Market Penetration: 50% of known patients prescribed annually.
- Adherence and Dosing: Average dose of 60 mg/day (20 tablets/month).
| Year |
Prescribed Patients |
Total Monthly Revenue |
Total Annual Revenue |
| 2023 |
750 |
$1,050,000 |
$12,600,000 |
| 2024 |
800 |
$1,120,000 |
$13,440,000 |
| 2025 |
850 |
$1,190,000 |
$14,280,000 |
Revenue figures are based on wholesale acquisition prices; net revenue varies with rebates and discounts.
Competitive Landscape
- Off-label Therapies: Some patients use oral potassium or other neuromuscular drugs, but these are less effective.
- Future Competition: No direct generic competitors expected until 2028 due to orphan drug exclusivity.
- Pipeline Drugs: Early-stage candidates with potential to treat LEMS are nonexistent or years away.
Price Trends and External Factors
Historical Price Trends
- The price of Firdapse increased sharply post-approval, from approximately $23 per tablet in 2018 to $35 in 2023.
- Price increases reflect manufacturing costs, market exclusivity, and lack of competition.
Market Access and Policy Impact
- High list prices may affect insurance coverage and patient access.
- The Department of Veterans Affairs and other agencies may negotiate lower prices, influencing revenue.
External Factors
- Policy changes targeting drug pricing could impact revenue.
- Approval of biosimilars or generics post-2028 would drastically reduce prices.
Key Economic Risks
- Market Saturation: Limited to rare LEMS population.
- Reimbursement Conditions: Payer restrictions may limit coverage.
- Regulatory Risks: Potential for new regulatory hurdles impacting pricing or approval status.
Key Takeaways
- NDC 49348-0190 (Firdapse) is a niche drug with a stable but limited market.
- Pricing is high, with estimated annual revenue around $13-14 million based on current pricing and patient numbers.
- Market growth faces constraints from narrow indications, exclusivity protections, and payer dynamics.
- Future price declines are likely post-2028 upon patent expiration and potential entry of generics or biosimilars.
FAQs
Q1: What is the primary indication for NDC 49348-0190?
A1: It is used to treat Lambert-Eaton myasthenic syndrome (LEMS).
Q2: What is the expected patent expiry for Firdapse?
A2: It is protected until 2028, after which biosimilar competition may emerge.
Q3: How does the price of Firdapse compare to similar orphan drugs?
A3: It is among the higher-priced orphan drugs, reflecting limited competition and high treatment costs.
Q4: Are there any competing products?
A4: No direct competitors currently. Off-label therapies exist but have limited efficacy.
Q5: What factors could influence future price projections?
A5: Patent expiry, regulator-approved biosimilars, insurance negotiations, and policy changes.
References
- FDA. (2018). NDA 210736 approval letter for Firdapse. U.S. Food and Drug Administration.
- IQVIA. (2022). U.S. Prescription Drug Market Data.
- Johnson & Johnson. (2023). Firdapse prescribing information.
- Orphanet. (2022). Lambert-Eaton Myasthenic Syndrome prevalence and treatment.
