Last updated: March 5, 2026
What is the Status and Use of NDC 72819-0161?
NDC 72819-0161 corresponds to Revestive (teduglutide), a glucagon-like peptide-2 (GLP-2) analog approved by the FDA in March 2012 for adults with short bowel syndrome (SBS) dependence on parenteral support. It enhances intestinal absorption capacity, reducing dependence on total parenteral nutrition (TPN).
Revestive's patent protection periods began in 2012, with exclusivity lasting until at least 2022; biosimilars are under development in various regions.
Market Size and Dynamics
Key Indications
- Short bowel syndrome (SBS): Chronic condition characterized by inadequate nutrient absorption.
- Patient Population: Estimated globally at around 20,000 adult patients, based on prevalence reports (e.g., Chen et al., 2010[1]).
- Treatment Duration: Typically long-term, with patients using the drug for months or years, enabling sustained revenue streams.
Competitive Landscape
- Direct competitors: No approved biosimilars or alternatives in the U.S. as of 2023.
- Off-label uses: Limited, primarily experimental, not significant market influence.
Regulatory and Reimbursement Environment
- Pricing: Revestive was launched with a wholesale acquisition cost (WAC) of approximately $135,000 per year per patient in initial commercial markets.
- Coverage: Cost-effectiveness has been confirmed by health authorities in some regions, but reimbursement remains a barrier in certain markets.
Market Penetration
- Initially targeted at the U.S., with expanding access in Europe and other developed markets.
- Market share remains limited by high cost, prescriber familiarity, and ongoing clinical adoption.
Price Projections
Current Pricing
| Region |
Approximate Annual Cost per Patient |
| U.S. |
$135,000 |
| Europe |
€110,000–€125,000 |
Note: Prices vary by payer negotiations, dosing adjustments, and regional policies.
Short-term Projections (Next 2 Years)
- No biosimilars currently approved in the U.S.
- Price stability expected unless market entry occurs.
- Reimbursement pressures could influence pricing downward by 5-10% in mature markets.
Medium-term Projections (3–5 Years)
- Biosimilar development in phase 3 or approval stages could lower prices 15–30% upon market entry.
- Patent cliffs anticipated around 2028, depending on legal extensions.
- Cost reductions may be driven by competitive biosimilar pricing and increased market access.
Long-term Projections (5+ Years)
- Biosimilar market entry could reduce prices to approximately $70,000–$90,000 annually.
- Market growth may reach 25,000–30,000 patients worldwide, considering increased diagnosis and expanded indications.
Market Growth Drivers and Risks
Drivers
- Growing awareness and diagnosis of SBS.
- Favorable clinical outcomes demonstrated in trials.
- Increasing utilization in developed markets with insurance coverage.
Risks
- Pending or potential biosimilar approvals in major markets.
- Reimbursement challenges due to high costs.
- Competition from alternative therapies and emerging biologics.
Summary of Price and Market Outlook
| Year |
Estimated Market Size (Patients) |
Expected Price Range (USD) |
Market Revenue (USD Millions) |
| 2023 |
10,000 |
$135,000 |
$1,350 |
| 2025 |
12,000 |
$120,000–$135,000 |
$1,440–$1,620 |
| 2028 |
15,000 |
$70,000–$90,000 |
$1,050–$1,350 |
These estimates assume steady adoption, no biosimilar competition before 2028, and stable reimbursement.
Key Takeaways
- NDC 72819-0161 (Revestive) is targeted at a niche but growing market for SBS.
- Current prices in developed markets average $135,000 annually per patient.
- The market is expected to remain stable in the short term; biosimilar entry could significantly impact pricing and market share by mid to late decade.
- Long-term growth hinges on expanded indications and increased diagnosis rates.
FAQs
1. What are the main competitors to Revestive?
There are no direct FDA-approved biosimilars or biologics. Off-label or experimental treatments, such as growth hormone or other intestinal therapies, are less established.
2. How will biosimilars affect pricing?
Introduction of biosimilars is projected to reduce prices by 15–30%, potentially lowering the annual treatment cost to $70,000–$90,000.
3. Are there regional pricing differences?
Yes. European prices are generally 10–20% lower than U.S. prices, influenced by healthcare systems and negotiation power.
4. When is patent expiration expected?
Patent protections are expected to expire around 2028, with possible extensions in certain jurisdictions.
5. What factors influence Revestive’s market growth?
Increased SBS diagnosis, clinical guideline adoption, reimbursement policies, and development of biosimilars or new therapies.
Sources:
[1] Chen, Y. C., et al. (2010). Epidemiology of short bowel syndrome. Gastroenterology Clinics of North America, 39(4), 767–781.
