Last updated: March 10, 2026
What is the drug associated with NDC 43598-0907?
NDC 43598-0907 corresponds to Ambrisentan, sold under the brand name Letairis. It is an oral endothelin receptor antagonist used primarily to treat pulmonary arterial hypertension (PAH). Approved by the FDA in 2007, it is prescribed for WHO Group 1 PAH in both adult men and women.
Market landscape overview
Market size and growth
The pulmonary arterial hypertension (PAH) market has experienced consistent growth driven by increased diagnosis and approval of targeted therapies. The global PAH drug market was valued at approximately USD 2.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 8% through 2030.
Key competitors
- Bosentan (Tracleer)
- Ambrisentan (Letairis)
- Macitentan (Opsumit)
- Riociguat (Adempas)
Ambrisentan maintains a niche share due to its specific efficacy profile and fewer side effects compared to some competitors.
Market penetration
Letairis has captured roughly 20-25% of the PAH market among endothelin receptor antagonists. It is predominantly prescribed for idiopathic PAH and connective tissue disease-associated PAH.
Geographic distribution
- North America accounts for about 50% of sales
- Europe contributes roughly 30%
- Asia-Pacific represents the fastest-growing segment, with a CAGR of 10% due to emerging healthcare infrastructure and increased diagnosis
Price analysis
Current pricing landscape
- Average wholesale price (AWP): Approximately USD 5,200 per 60-tablet pack (a 30-day supply)
- Average sales price: About USD 4,800 per pack, reflecting discounts and negotiation
- Reimbursement: Predominantly covered by Medicare, Medicaid, and private insurers
Pricing factors and trends
- Market exclusivity: Patents expire in 2023, opening potential for generic entry
- Discounting pressures: Payers increasingly employ tiered formulary structures to reduce costs
- Supply chain influences: Manufacturing scales and raw material costs impact final prices
Impact of patent expiration
The expiration of key patents may lead to generic versions entering the market within the 2024-2026 window, potentially reducing prices by 50-70%. Historical precedents with similar drugs suggest a drop of approximately USD 2,500–3,000 per 60-tablet pack.
Price projections (2023-2030)
| Year |
Estimated Price (USD per 60 tablets) |
Key Factors |
| 2023 |
USD 4,800 – 5,200 |
Patent protections remain; limited competition |
| 2024 |
USD 3,600 – 4,000 |
Patent expiry; entry of first generics |
| 2025 |
USD 2,700 – 3,200 |
Market penetration of generics; increased price competition |
| 2026 |
USD 2,200 – 2,800 |
Further generic competition; possible formulation or biosimilar entries |
| 2027-2030 |
USD 2,000 or lower |
Market stabilization; potential for biosimilars or combination therapies |
Regulatory and policy impacts
- The approval of biosimilar or generic compounds will sharply influence pricing.
- Policy shifts toward value-based pricing could pressure prices downward.
- International pricing regulation could harmonize or further reduce costs in certain markets.
Conclusion
The market for Ambrisentan (NDC: 43598-0907) is evolving from a branded-dominant landscape toward a competitive environment with generics expected soon. Prices are projected to decline significantly after patent expiry, with a steep reduction beginning in 2024.
Key Takeaways
- The current average wholesale price is approximately USD 5,000 per 30-day supply.
- Market share held by Letairis is about 20–25% in PAH-specific treatments.
- Patent expiry in 2023 will likely lead to a 50–70% price reduction within two years.
- Asia-Pacific markets will see faster adoption of generics and price declines.
- Ongoing policy and regulatory developments could influence future pricing trajectories.
5 FAQs
Q1: When will generics for Ambrisentan become available?
A1: Patent expiry around 2023-2024, with generics entering the market by 2024 at the earliest.
Q2: What factors could slow down price declines?
A2: Regulatory barriers, patent disputes, and limited generic manufacturing capacity.
Q3: How does Letairis compare to its competitors in pricing?
A3: Currently, priced closely with Eli Lilly's Tracleer but generally higher than emerging generics.
Q4: What is the expected impact of biosimilars?
A4: Biosimilars could further reduce prices but are less likely for small molecule drugs like Ambrisentan than for biologics.
Q5: What demographic trends influence market growth?
A5: Rising prevalence of PAH in aging populations and increased diagnosis contribute to growth.
References
- MarketResearch.com. (2022). Pulmonary Arterial Hypertension Market Report.
- U.S. Food and Drug Administration. (2007). FDA Approval Letter for Letairis.
- IQVIA. (2022). Healthcare Market Trends and Pricing Reports.
- EvaluatePharma. (2022). Global Market Forecast for PAH Drugs.
- World Health Organization. (2021). Pulmonary Hypertension: Epidemiology and Treatment Trends.
