Last updated: February 13, 2026
What is the current market status for NDC 50474-0710?
NDC 50474-0710 is marketed as Piqray (alpelisib), a PI3K inhibitor approved by the FDA in May 2019 for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, in combination with fulvestrant. Since approval, Piqray has established a niche in targeted breast cancer therapy, driven by the prevalence of PIK3CA mutations in this population.
Sales Data:
In 2022, Piqray generated approximately $250 million in U.S. sales, reflecting steady growth from its launch figures of around $100 million in 2020. The growth is attributed to increasing diagnostic testing for PIK3CA mutations and expanding indications.
Market Share:
Piqray holds an estimated 70-80% share within the PIK3K inhibitor segment for breast cancer, competing primarily against investigational agents and off-label use of other targeted therapies. The drug's adoption correlates with the rising use of NGS (Next Generation Sequencing) for mutation detection.
What are the key factors influencing market penetration?
Regulatory landscape
The FDA approved Piqray's expanded indication in November 2021 for the adjuvant treatment of early breast cancer with PIK3CA mutations, which broadens its potential patient population. The approval hinges on data from the SOLAR-1 trial, which demonstrated improved invasive disease-free survival. Expanded use increases the addressable market.
Diagnostic testing
Increased utilization of NGS testing improves patient identification for Piquray. The growth of testing services correlates with a higher number of eligible patients. The American Society of Clinical Oncology (ASCO) recommends routine testing, supporting market expansion.
Competitive landscape
Current competitors include experimental agents within clinical trials targeting PIK3CA mutations or downstream pathways. No direct biosimilar competition exists yet, supporting pricing power.
Pricing environment
The wholesale acquisition cost (WAC) for Piqray has been set at approximately $11,050 per month, based on the 2022 price. Insurance coverage and patient assistance programs influence actual net prices.
What are price projections moving forward?
Short-term projections (1-2 years)
The price of Piqray remains stable with slight increases tied to inflation and formulation adjustments. The net price is expected to hover around $11,000–$12,000 per month. Payers' reimbursement policies, however, place constraints on high-price drugs, influencing net revenue.
Medium-term projections (3-5 years)
If the expanded adjuvant indication drives higher adoption, volume growth could offset modest price increases. Piqray's price could escalate to approximately $12,500 per month, aligned with the average upward trend seen in specialty drugs.
Long-term outlook (5+ years)
Emergence of biosimilars or generics is unlikely within this timeframe due to patent exclusivity and exclusivity periods. However, competition from novel agents targeting similar pathways may exert downward pressure on prices. Market dynamics suggest a potential decrease in net prices by 10-15% once biosimilars or new treatments enter the segment.
Impact of biosimilars and generics
Patent expiry in 2028-TV is anticipated, which could lead to price erosion; however, current patent protections prolong exclusivity, maintaining a high price environment through at least 2030.
What are regulatory and patent considerations?
Patent landscape
Piqray is protected by patents extending into 2028, with certain formulations and methods of use being patented. These patents prevent generic competition until expiry. The compound itself is not yet at risk of biosimilar entry due to the small molecule status but is protected through its chemical patents.
Regulatory hurdles
FDA approval for expanded indications provides market exclusivity; however, reimbursement and formulary inclusion will influence market penetration more than regulatory barriers.
What are the main barriers to market growth?
- Limited patient diagnosis rates: Although PIK3CA mutations are prevalent, not all eligible patients undergo genetic testing.
- Pricing and reimbursement constraints: High drug costs may limit access, especially outside of payers' preferred formulary options.
- Competitive innovations: Emerging therapies targeting downstream or parallel pathways could impact Piqray's dominance.
Summary
NDC 50474-0710 (Piqray) is a targeted breast cancer therapy with stable pricing around $11,000 per month. Market growth depends on expanded indications, increased testing, and payer dynamics. The potential for biosimilars or generics exists post-2028, potentially impacting prices. The drug maintains a leadership position due to current patent protections and its niche in PIK3CA-mutated breast cancer treatment.
Key Takeaways
- Piqray generated ~$250 million U.S. sales in 2022, with steady growth.
- Current price: ~$11,000/month, forecasts suggest slight increases with market expansion.
- Expansion into early-stage breast cancer with the 2021 FDA approval broadens market.
- Patent protections extend through 2028, delaying biosimilar effects.
- Market growth is constrained by testing rates, reimbursement policies, and emerging competitors.
FAQs
1. How does Piqray compare to other treatments in the same segment?
Piqray has the largest market share among PIK3 inhibitors for breast cancer due to FDA approval and diagnostic testing recommendations. Its main competitors are clinical-stage agents rather than approved therapies.
2. What factors could accelerate Piqray price increases?
Increased market adoption from expanded indications, higher testing rates, and limited competition could support prices around $12,500/month in the near term.
3. When is generic or biosimilar entry expected?
Patent protection lasts until 2028; biosimilar competition for small molecules like Piqray is unlikely before then.
4. What impact will the expanded indication have on the market?
It should significantly increase the eligible patient base, promoting higher sales volume but not necessarily affecting list prices.
5. How do reimbursement policies affect Piqray's market?
Reimbursement negotiations and formulary placements are critical; restrictive coverage can limit market penetration despite high demand.
References
- U.S. Food and Drug Administration. Piqray (alpelisib) label. 2019.
- IQVIA. 2022 pharmaceutical sales data.
- American Society of Clinical Oncology. Guidelines for genetic testing in breast cancer. 2021.
- GBI Research. Market outlook for PI3K inhibitors. 2022.
