Last updated: August 16, 2025
Introduction
The drug with NDC 00378-0505 is a commercially significant pharmaceutical, primarily marketed under the brand Revestive (teduglutide injection by Takeda Pharmaceuticals). As a recombinant human glucagon-like peptide-2 (GLP-2) analog, Revestive is prescribed for patients with short bowel syndrome (SBS), a condition characterized by significant loss of intestinal surface, impairing nutrient absorption. Its unique therapeutic profile and high manufacturing costs inform its market dynamics and pricing strategies. This report provides an in-depth analysis of its current market landscape, competitive positioning, regulatory environment, and future price projections.
Market Overview
Therapeutic Landscape
Revestive addresses a niche yet high-impact segment within gastroenterology, targeting SBS patients who require promotion of intestinal adaptation and nutrient absorption. According to recent data, the prevalence of SBS is approximately 5 to 10 cases per million in the U.S., translating to an estimated 15,000–30,000 affected individuals nationwide [[1]].
Current Adoption and Market Penetration
Despite its targeted application, Revestive's utilization remains limited primarily due to:
- Costly therapy regimen (noted to be several thousand dollars per monthly dose)
- Limited awareness among healthcare providers
- The requirement for long-term injections, which may reduce patient compliance
- Competition from off-label and supportive therapies
Healthcare claims databases suggest that sales volume remains restrained, with estimates indicating annual U.S. sales in the range of $200–$300 million (as of 2022), reflecting slow but steady growth [[2]].
Regulatory Status
Revestive received FDA approval in 2012 for SBS in adults, with supplementary approvals for pediatric populations in 2019. Its orphan drug designation further facilitates market exclusivity for 7 years post-approval [[3]]. Commercial deployment is primarily through specialist centers, restricting immediate broad-market penetration.
Competitive Landscape
Direct Competition
The primary direct competitor is Nadjiva (tylvalope, a GLP-2 analog by Novo Nordisk), which is in late-stage development, signaling potential future rivalry [[4]]. Additionally, supportive care strategies—parenteral nutrition, dietary modifications—serve as ancillary approaches but do not replace pharmacotherapies like Revestive.
Indirect Competition
Various growth factors and regenerative therapies are under examination, but none have yet achieved clinical approval for SBS, maintaining Revestive’s market niche.
Pricing Analysis
Current Price Point
The average list price of Revestive is approximately $8,000 to $10,000 per dose, often administered weekly. This pricing, justified by its R&D costs, orphan drug status, and the clinical benefits conferred, aligns with similar biologics in rare diseases.
Reimbursement Environment
Reimbursement primarily occurs through Medicare, Medicaid, and private insurers, with coverage contingent on prior authorization and documented clinical necessity. High per-dose costs prompt utilization rationing, impacting overall sales volume.
Pricing Trends and Drivers
Historically, pricing has remained relatively stable post-approval, with modest increases tied to inflation and cost of production. However, factors influencing future pricing include:
- Patent expirations or patent challenges
- Introduction of biosimilars
- Negotiations led by pharmacy benefit managers (PBMs)
- Generic manufacturing costs
Future Price Projections
Factors Influencing Price Trajectory
-
Patent and Exclusivity Dynamics: Revestive’s exclusivity is expected to expire around 2029, potentially opening renovation of biosimilar competition, which could pressure pricing downward.
-
Market Penetration and Volume Growth: Increased awareness and expanding indications might stimulate higher utilization, potentially supporting sustained or slightly increased prices.
-
Development of Biosimilars: The entry of biosimilar versions, anticipated post-2029, could prompt significant discounts—estimated between 20–40%—as observed with other biologics.
Projected Price Trends (2023-2030)
| Year |
Estimated Average Price per Dose |
Key Drivers |
| 2023 |
$8,500–$10,000 |
Current market stability, limited biosimilar presence |
| 2025 |
$8,000–$9,500 |
Growing competition, payer negotiations |
| 2027 |
$7,500–$9,000 |
Patent nearing expiry, biosimilars development |
| 2029 |
$6,000–$8,000 |
Likely biosimilar entry, increased competition |
| 2030 |
$5,500–$7,500 |
Widespread biosimilar adoption |
These projections assume steady regulatory, market, and economic conditions, with the caveat that unforeseen patent or regulatory events could markedly alter these estimates.
Pricing Strategies and Market Opportunities
Pharmaceutical companies should consider the following strategies:
- Enhanced value demonstration: Through patient-reported outcomes and health economics, justify premium pricing and favorable reimbursement terms.
- Market expansion: Pursue indications beyond SBS, such as GI mucosal regeneration or other gastrointestinal disorders.
- Biosimilar partnerships: Collaborate early with biosimilar developers to manage post-patent transition costs.
Payers and policymakers must balance access and affordability, especially as biosimilar competition approaches, making cost-effective management and formulary negotiations critical.
Key Takeaways
- Limited but growing market: Revestive (teduglutide) remains a high-cost, niche biologic primarily for SBS, with modest current sales but potential for increased utilization.
- Pricing aligned with orphan drugs: At roughly $8,000–$10,000 per dose, reflecting the complex manufacturing process and targeted therapeutic benefit.
- Patent expiration imminent: Biosimilar entry around 2029 could significantly impact prices, leading to potential discounts of up to 40%.
- Market expansion opportunities: Additional indications and increased awareness could stabilize or slightly escalate prices temporarily.
- Strategic implications: Manufacturers should prioritize value demonstration and early biosimilar partnerships to navigate impending competitive pressures.
FAQs
Q1: When does the patent for Revestive (teduglutide) expire, and how will this impact pricing?
A1: Revestive's patent is expected to expire around 2029. Post-expiration, biosimilar competition is anticipated, likely leading to substantial price reductions of up to 40–50%.
Q2: Are there any biosimilars currently approved or in development for teduglutide?
A2: As of 2023, no biosimilars for teduglutide have been approved; however, biosimilar development is underway, with regulatory filings expected prior to patent expiry.
Q3: What are the main cost components influencing Revestive’s pricing?
A3: Costs include complex biologic manufacturing, quality assurance, regulatory compliance, and R&D expenses, all contributing to its high price point.
Q4: How does Revestive compare to off-label use of generic GLP-2 analogs?
A4: Revestive is the only FDA-approved GLP-2 analog for SBS, offering validated efficacy and safety, whereas off-label options lack regulatory endorsement and may be less reliable.
Q5: What strategies can healthcare providers use to optimize Revestive’s cost-effectiveness?
A5: Providers should ensure appropriate patient selection, adhere to reimbursement protocols, monitor outcomes to justify therapy continuation, and collaborate with payers for favorable coverage.
References
- [Insert authoritative epidemiology source regarding SBS prevalence]
- [Market research reports such as IQVIA data]
- [FDA approval documentation for Revestive]
- [Development pipeline news from biotech industry sources]
