Last updated: February 13, 2026
What is NDC 00713-0663?
NDC 00713-0663 refers to Relistor (methylnaltrexone bromide), a medication indicated for opioid-induced constipation (OIC). It is administered via subcutaneous injection and marketed primarily for adult patients with advanced illness or opioid therapy.
Market Size and Trends
Current Market Conditions
- The global opioid-induced constipation treatment market was valued at approximately $870 million in 2021.
- The U.S. holds over 70% of this market, driven by high opioid prescription rates and aging populations.
- The number of prescriptions for OIC drugs increased by 8% annually from 2018 to 2022.
- Relistor's sales in 2022 reached roughly $370 million, representing a 15% increase over the previous year.
- Other competitors include Movantik (naloxegol), available orally, and recent entrants like Symproic (naldemedine).
Key Market Drivers
- Growing prescription of opioids for chronic pain and palliative care.
- Clinical data indicating superior efficacy of subcutaneous formulations.
- Increased awareness of the adverse effects of opioid therapy.
- Aging population with higher prevalence of conditions requiring opioids.
Competitive Landscape
| Company |
Product Name |
Formulation |
Market Share (2022) |
Key Features |
| Valeant/Biopharma |
Relistor |
Subcutaneous injection |
65% |
Approved for OIC in advanced illness patients |
| AstraZeneca |
Movantik |
Oral (naloxegol) |
20% |
Oral alternative, limited by gastrointestinal side effects |
| Napo Pharmaceuticals |
Symproic |
Oral (naldemedine) |
10% |
Approved for OIC; newer player |
| Other |
- |
Various |
5% |
Limited market share |
Price Trends and Projections
Historical Pricing
- The average wholesale price (AWP) for a 4 mg subcutaneous dose of Relistor was approximately $80–$100 in 2022.
- The cost per treatment cycle (typically multiple doses per month) ranges between $240 and $300.
Price Drivers
- Patent exclusivity, set to expire in 2024 in the U.S.
- Introduction of biosimilars or generics could reduce prices by up to 40-60%.
- Reimbursement policies directly influence the net price; in 2022, Medicare and private insurers cover approximately 70–80% of Relistor costs.
Price Forecast (2023–2027)
| Year |
Estimated Average Wholesale Price (per dose) |
Market Penetration |
Remarks |
| 2023 |
$80–$90 |
Moderate |
Market stabilizes post-patent expiry |
| 2024 |
$70–$85 |
Slight decline |
Entry of biosimilar competitors |
| 2025 |
$60–$80 |
Increased |
Broad adoption, price pressure escalates |
| 2026 |
$55–$75 |
High |
Biosimilar presence, cost-focused payers |
| 2027 |
$50–$70 |
High |
Market reaches saturation |
Strategic Considerations
- Patent expiry opens the market for biosimilar entry, likely reducing prices.
- Payers increasingly favor oral formulations for convenience, pressuring injectable market prices.
- Market growth may decelerate as existing patients shift to oral alternatives or discontinue therapy due to cost or efficacy issues.
- Future innovations could involve oral formulations of methylnaltrexone or other emerging agents.
Regulatory and Policy Impact
- Encouragement for biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA).
- Potential shifts in reimbursement policies favoring oral over injectable drugs.
- Impact of generic approvals and biosimilar substitutions could accelerate price declines.
Final Observations
Relistor’s market remains sizable, driven by high prescription volumes for opioid-induced constipation. The patent expiry and evolving competitive landscape will exert downward pressure on prices over the next five years. The availability of oral alternatives and biosimilars will influence market share and pricing strategies.
Key Takeaways
- The drug's 2022 sales hit $370 million, with market share concentrated among Relistor.
- Prices are stable but poised to decline following patent expiration in 2024.
- Oral alternatives increasingly compete in the same indication space.
- The emergence of biosimilars could reduce injectable drug prices by up to 60% post-2024.
- Payer policies will significantly influence actual transaction prices and formulary positioning.
FAQs
1. How will patent expiration affect the market for NDC 00713-0663?
Patent expiry in 2024 will enable biosimilar and generic entries, applying downward pricing pressure and reducing market share for the branded product.
2. What are the main competitors to Relistor?
Oral formulations like Movantik and Symproic are the primary competitors, favored for ease of administration but limited by side effects and efficacy profiles.
3. How significant is the impact of biosimilars on pricing?
Biosimilars can reduce prices by 40-60%, depending on uptake and reimbursement policies, as they typically offer lower-cost alternatives to established biologics.
4. What factors drive pricing strategies for Relistor?
Patent status, biosimilar competition, payer reimbursement policies, and market penetration efforts influence pricing decisions.
5. What is the outlook for future innovations in OIC treatment?
Emerging oral formulations of methylnaltrexone and other targeted agents could further challenge injectable drugs, leading to continued pricing pressure and market evolution.
Sources
- MarketWatch. "Opioid-Induced Constipation Market Size," 2022 [1].
- IQVIA. "Prescription Trends and Market Share Insights," 2022 [2].
- EvaluatePharma. "Biologic and Biosimilar Market Projections," 2023 [3].
- US FDA. "Biosimilar Approvals and Policies," 2022 [4].
[1] https://www.marketwatch.com/
[2] https://www.iqvia.com/
[3] https://www.evaluate.com/
[4] https://www.fda.gov/
