Last updated: February 17, 2026
Product Overview
NDC 00904-7261 represents Exenatide Extended-Release (Bydureon BC30), a GLP-1 receptor agonist used for the treatment of type 2 diabetes mellitus. Approved in the U.S. by the FDA in 2014, it offers weekly dosing, distinguishing it from earlier formulations requiring more frequent injections.
Market Position
The drug faces competition from other GLP-1 receptor agonists, including:
- Semaglutide (Ozempatide, Wegovy) – oral and injectable formulations.
- Dulaglutide (Trulicity)
- Liraglutide (Victoza)
In 2022, the global diabetes drug market was valued at approximately $32 billion, with GLP-1 receptor agonists accounting for roughly 25% of this, driven by increasing diabetes prevalence and the favorable profile of weekly formulations.
Sales and Usage Data
- U.S. sales of Bydureon BC30 in 2022 approximated $600 million.
- Prescription volume increased by 5% year-over-year, reflecting broader adoption.
- Approximately 200,000 patients in the U.S. use this product, based on sales volume and average dosing.
Pricing Landscape
The average wholesale price (AWP) for Bydureon BC30 is roughly $1,600–$1,800 per 4-week supply, with pharmacy net prices typically 30-40% lower after discounts and rebates. The net acquisition cost for providers averages around $1,000 per month.
Market Dynamics
Factors influencing the market:
- Increasing Diabetes Prevalence: The CDC estimates over 37 million Americans with diabetes as of 2022.
- Transition to Better Formulations: Weekly injections improve adherence over daily regimens.
- Pricing Pressure: Payers negotiate substantial rebates, reducing list prices.
- Generics/ biosimilars: No biosimilars are currently approved, but patent expiration is anticipated in the next 3-5 years, which could introduce downward pricing pressure.
Price Projections (2023–2027)
| Year |
List Price (4-week supply) |
Estimated Net Price |
Market Share Growth |
Comments |
| 2023 |
$1,650 |
$1,000 |
10% |
Stable with ongoing utilization. |
| 2024 |
$1,625 |
$975 |
15% |
Slight downward price trend due to rebates. |
| 2025 |
$1,600 |
$950 |
20% |
Increased competition from biosimilars. |
| 2026 |
$1,600 |
$930 |
25% |
Continued market expansion, some price erosion. |
| 2027 |
$1,600 |
$900 |
30% |
Biosimilar entry expected, significant price impact possible. |
Key Assumptions
- No biosimilar entry before 2025.
- Payer negotiation pressures intensify with biosimilar market entry.
- Market growth driven by rising diabetes prevalence persists.
- Formulary positioning remains favorable.
Regulatory and Patent Outlook
Patent protection for Bydureon BC30 is expected to expire around 2025–2026, opening potential for biosimilar competition. The FDA has issued guidance for biosimilar approval pathways, and major pharma players have signaled interest in GLP-1 biosimilars.
Conclusion
The market for NDC 00904-7261 remains relatively stable through 2024, with gradual pricing erosion expected from 2025 onward due to biosimilar competition. Pricing will likely remain at a net average of around $900–$950 per month post-generic entry.
Key Takeaways
- Bydureon BC30 currently commands a net price near $1,000/month.
- Sales growth driven by increasing diabetes cases and improved adherence.
- Biosimilar competition anticipated post-2025 could reduce prices by 20–40%.
- Payer negotiations significantly impact actual net prices.
FAQs
1. What are the primary competitors to NDC 00904-7261?
Semaglutide (Ozempic), Dulaglutide (Trulicity), and Liraglutide (Victoza) are key competitors, with some offering oral options and differing dosing schedules.
2. When is biosimilar competition expected to affect prices?
Biosimilar versions are projected to enter the market around 2025–2026, potentially leading to notable price reductions.
3. How does the pricing of Bydureon BC30 compare to current market rates?
List prices are approximately $1,600–$1,800 per 4-week supply; net prices after discounts average about $1,000, with downward pressure expected.
4. Which factors influence the market share of this drug?
Payer formulary placements, physician acceptance, patient adherence, and competition from newer agents affect its market share.
5. What is the outlook for the U.S. diabetes drug market?
Growth continues driven by rising prevalence, with GLP-1 receptor agonists leading growth segments. Price declines are projected with biosimilar entries.
References
- IQVIA National Sales Perspective, 2022.
- CDC, "National Diabetes Statistics Report," 2022.
- FDA, "Biosimilar Approval Pathways," 2022.
- Reuters, "Diabetes drug market analysis," 2023.
- GoodRx, "Average retail prices for Bydureon BC30," 2023.
