Last updated: March 1, 2026
What is the Drug Represented by NDC 00527-1698?
NDC 00527-1698 corresponds to Selexipag (Uptravi), approved by the FDA in December 2015. It is used for the treatment of pulmonary arterial hypertension (PAH). The drug is an oral prostacyclin receptor agonist that acts to dilate pulmonary vessels, reducing pulmonary vascular resistance.
Commercial Landscape
Market Size
- The global pulmonary arterial hypertension (PAH) treatment market was valued at approximately $3 billion in 2021.
- Estimated Compound Annual Growth Rate (CAGR): roughly 7-8% from 2022 to 2027.
- The U.S. accounts for roughly 60% of the market share, driven by higher treatment rates and reimbursement access.
Market Drivers
- Increasing prevalence of PAH, especially among adults with connective tissue diseases, congenital heart disease, or idiopathic cases.
- Growing adoption of oral therapies over parenteral options.
- Expanded label indications and heightened physician awareness.
Competition
| Drug Name |
Class |
Approval Years |
Market Share (2022) |
Pricing (per month) |
| Selexipag (Uptravi) |
Prostacyclin receptor agonist |
2015 |
35% |
~$7,500 |
| Macitentan (Opsumit) |
Endothelin receptor antagonist |
2013 |
25% |
~$6,000 |
| Ambrisentan (Letairis) |
Endothelin receptor antagonist |
2007 |
20% |
~$4,500 |
| Riociguat (Adempas) |
Soluble guanylate cyclase stimulator |
2013 |
15% |
~$7,200 |
Key Market Dynamics
- Uptravi maintains a leading position due to its oral route.
- Patent exclusivity extends until 2027, with potential for extensions based on filings.
- Biosimilar or generic entry is unlikely before 2027 due to patent protections and market exclusivity.
Price Projections
Historical Pricing Trends
- Initial launch pricing for Uptravi: approximately $7,500 per month.
- Over five years (2016-2021), annual list prices remained relatively stable but experienced slight reductions in negotiated rebates and discounts.
- Market pressure from payers and increased use of alternative therapies could exert downward pricing pressure.
Short to Mid-Term Outlook (2023-2027)
- Stable pricing near current levels: Expect prices to stay within the current range of $7,000 to $7,500 per month.
- Potential reductions: Payer negotiations and formulary placements may lead to discounts of 5-10%, reducing net prices.
- Post-2027: Price reductions could accelerate with patent expiration and entry of biosimilars, though specific timing depends on regulatory and market factors.
Long-Term Projections (2028 and beyond)
- Likely decline in price to $4,500 to $5,500 per month following generic or biosimilar competition.
- Impact of market penetration of less expensive therapies or combination treatment strategies.
Key Considerations for Stakeholders
- Patent protection: Will remain until at least 2027, delaying generic competition.
- Regulatory changes: Price controls or policy shifts could influence price trends.
- Market uptake: Growing acceptance of oral PAH therapies supports sustained revenue.
- Payer tactics: Increased use of prior authorizations and step therapy could pressure net prices downward.
Final Thoughts
Selexipag (Uptravi) holds a dominant position in the PAH oral therapy segment with stable pricing through 2027. Market growth is driven by increasing prevalence and treatment adoption. Price reductions are likely post-patent expiration, but near-term prices expect to remain stable, supporting profitability for current manufacturers.
Key Takeaways
- NDC 00527-1698 (Uptravi) is a leading oral PAH treatment with approximately $7,500/month pricing.
- The global PAH market grows annually at 7-8%, with Uptravi holding about 35% market share.
- Price stability through 2027 is expected, with potential reductions following patent expiry.
- Competition from biosimilars and generics will influence long-term pricing dynamics.
- Payer negotiations and formulary placements are critical to net pricing strategies.
FAQs
1. When will generic versions of Uptravi enter the market?
Patent expiration and regulatory exclusivity suggest 2027 or later; no generic entries are approved yet.
2. How does Uptravi compare to other PAH medications?
It is an oral prostacyclin receptor agonist with a distinct mechanism, leading to higher adherence and convenience compared to parenteral options like epoprostenol.
3. Are there plans for label expansion that could influence the market?
As of now, no major label expansion has been announced; ongoing clinical trials may shape future indications.
4. What pricing strategies are manufacturers expected to pursue?
Maintaining market share through negotiations, volume discounts, and new formulations; price reductions are likely post-patent expiration.
5. What factors could accelerate price declines for Uptravi?
Entry of biosimilars, increased clinical use of alternative therapies, and policy changes targeting drug pricing.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2015). Uptravi (Selexipag) Approval Letter.
[3] Evaluate Pharma. (2022). World Market Forecasts.
[4] MedAd News. (2022). PAH Market Trends.
[5] Patent and Exclusivity Data. (2023). US Patent Office.
