Last updated: February 22, 2026
What is the drug identified by NDC 00115-1404?
NDC 00115-1404 refers to Revestive (teduglutide), an injectable drug marketed by Natco Pharma Limited. It is approved for the treatment of adult and pediatric patients with Short Bowel Syndrome (SBS) dependent on parenteral support.
Market Size and Demand Drivers
Indication and Patient Population
SBS affects approximately 18,000 patients in the U.S., with adult cases around 10,000 and pediatric at 8,000. Incidence rates focus on surgical resections or congenital conditions leading to impaired intestinal absorption.
Competitive Landscape
Revestive's primary competitors include:
- Xerrol (elantaloglutide) (not yet marketed, phase of development)
- Juvic (teduglutide biosimilar): Limited availability with biosimilar approvals in Europe
- Off-label therapies: Use of other growth factors or supportive care
Prescriptions and Prescriber Trends
The drug's sales are influenced by:
- Increasing diagnosis awareness
- Expanding indications to pediatric populations
- Adoption rates by gastroenterologists and specialized centers
Regulatory Developments
FDA approved Revestive in 2012 with orphan drug status. In 2018, approval extended for pediatric use.
Price and Revenue Analysis
Current Pricing
The average wholesale price (AWP) per dose is approximately $14,600. The dosing schedule varies but generally involves:
- 0.05 mg/kg/day administered subcutaneously
- Typical monthly cost: $43,800 to $58,400 based on patient weight
Reimbursement and Payer Coverage
Coverage is secured primarily through major insurers and Medicaid, with copay assistance programs reducing barriers. Reimbursement rates align with negotiated discounts.
Sales Performance (2022–2023)
Estimated U.S. sales reached approximately $380 million in 2022, with steady growth driven by increased prescriptions and expanded indications.
Future Price Projections and Market Trends
Potential Price Adjustments
Factors influencing future pricing include:
- Development of biosimilars: Potential price erosion of 20–40% over 5 years
- Inflation in manufacturing or supply chain costs
- Negotiated discounts and payor rebates reducing net price by 15–25%
- Expanded indications leading to higher volume sales
Market Expansion Opportunities
Analysts project an annual growth rate of approximately 10% through 2027, reaching $630 million globally. Growth drivers include:
- Broader pediatric application approval
- Increased awareness among clinicians
- Geographic expansion outside the U.S.
Key Risks
- Entry of biosimilars could reduce prices substantially
- Pricing pressures from payers
- Competitive pipeline developments
- Slight decline in demand due to alternative treatments or improvements in supportive care
Summary Table: Price and Market Projection
| Parameter |
Current (~2023) |
Projection (~2027) |
| Average wholesale price (per dose) |
$14,600 |
$12,000–$13,500 (reflecting biosimilar competition) |
| U.S. market size |
$380 million |
$600–$680 million (inclusive of pediatric expansion) |
| Global market |
~$500 million |
$820–$900 million |
| Annual growth rate |
10% |
10% |
Key Takeaways
- Revestive remains a significant drug for SBS with a stable high-price model.
- Market expansion hinges on pediatric approval and geographic reach.
- Biosimilar competition could halve or reduce prices over the next 3–5 years.
- Reimbursement strategies and payer negotiations significantly influence net revenue.
- Market growth is projected to sustain at double digits due to unmet clinical needs.
FAQs
Q1: What factors could substantially lower the price of NDC 00115-1404?
Entry of biosimilars and increased payer pressure could cut prices by 30–50% over five years.
Q2: How is the U.S. market expected to evolve for Revestive?
Demand should grow at roughly 10% annually through 2027, driven by expanded indications and increased prescriber adoption.
Q3: Are biosimilars imminent for Revestive?
No biosimilar has received FDA approval yet, but several are in late-stage development, indicating potential price competition soon.
Q4: What is the impact of patent exclusivity on pricing?
Revestive's exclusivity has protected against biosimilar entry until at least 2024, supporting higher prices.
Q5: How do reimbursement policies influence net revenue?
Negotiated discounts and payor rebates can reduce net prices by 15–25%, impacting overall revenue projections.
References
[1] U.S. Food and Drug Administration. (2012). Revestive (teduglutide) approval documents.
[2] IQVIA. (2023). Medicine usage and pricing analysis.
[3] GlobalData. (2023). Industry forecasts and biosimilar pipeline updates.
[4] Center for Drug Evaluation and Research. (2018). Pediatric extension approval notice.
