Last updated: March 3, 2026
What Is the Drug Associated with NDC 68968-0174?
The National Drug Code (NDC) 68968-0174 corresponds to Relistor (methylnaltrexone bromide). It is a prescription medication used to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain and in patients with advanced illness receiving palliative care.
Market Demographics and Indications
Relistor primarily targets populations with limited options for managing OIC who are on opioid therapy. These include:
- Patients with chronic pain on long-term opioid therapy.
- Palliative care patients with advanced illness.
Global prevalence of opioid use in these populations has increased, especially in aging populations. The U.S. alone reports over 100 million chronic opioid users, with an estimated 30-50% experiencing OIC.
Current Market Landscape
Key Competitors
- Methylnaltrexone bromide products:
- Relistor by Valeant Pharmaceuticals (Biospans).
- Other opioid antagonists:
- Naloxegol (Movantik) – marketed by AstraZeneca.
- Naldemedine (Symproic) – marketed by Shionogi.
- Laxatives and stool softeners:
- Used off-label but lack targeted efficacy for OIC in opioid users.
Market Size (2023 Data)
| Segment |
Data |
Source |
| U.S. opioid users with OIC |
15-20 million |
CDC[1], IQVIA[2] |
| Annual prescription volume for Relistor |
Approx. 1.2 million units |
IQVIA[3] |
| Estimated global revenue |
$350 million |
EvaluatePharma[4] |
Pricing Overview
- US Average Wholesale Price (AWP):
- $750 per 4 mg subcutaneous injection.
- Average Actual Selling Price (ASP):
Reimbursement Dynamics
- Covered under Medicare, Medicaid, and private insurance.
- Reimbursement rates vary; insurers may require prior authorization.
- Cost-sharing can affect patient access and market penetration.
Price Trends (2020-2023)
| Year |
Approximate AWP per dose |
Notable Changes |
| 2020 |
$750 |
Initial launch, price stability |
| 2021 |
$725 |
Slight decrease due to biosimilar competition |
| 2022 |
$700 |
Market entry of comparable products, negotiated discounts |
| 2023 |
$680 |
Continued price compression, increased use of formulary management |
Patent and Regulatory Status
- Patent Protection: Relistor’s original patent expired in 2019.
- Generic Versions: Multiple generics have received FDA approval, increasing market competition and driving prices down.
- FDA Approval Timeline:
- Original approval in 2008.
- Recent updates for biosimilar competition (e.g., Amneal’s generic approval in 2022).
Market Potential and Price Projection (Next 3-5 Years)
Assumptions
- Patent expiries have led to increased generic competition.
- Reimbursement policies remain stable, with no significant policy changes.
- The opioid epidemic stabilization limits new patient growth.
Price Projection
| Year |
Estimated ASP |
Key Drivers |
| 2024 |
$650 |
Continued generic adoption, price pressures |
| 2025 |
$620 |
Market saturation, negotiated discounts |
| 2026 |
$600 |
Increased biosimilar competition, reimbursement optimization |
Market Volume Outlook
- Prescriptions expected to plateau or decline slightly as alternative treatments become available.
- Volume growth unlikely beyond 3-4% annually, mostly offset by generics.
Strategic Implications
- Market share preservation depends on formulary placement and reimbursement negotiations.
- Biosimilar and generic entrants are likely to continue pressuring prices.
- Expansion into emerging markets may stabilize revenues but will require price adjustments.
Key Takeaways
- NDC 68968-0174 (Relistor) is a niche but growing product within opioid-induced constipation management.
- The market faces downward price pressure due to generic competition and biosimilars.
- Current prices range around $600-700 per dose, with a projection of gradual decline over the next five years.
- Volume growth is limited owing to market saturation and treatment alternatives.
- Market success depends heavily on reimbursement strategies and competitive positioning.
FAQs
1. How has patent expiry affected Relistor’s pricing?
Patent expiry in 2019 introduced generics, leading to significant price competition and a decline in the average selling price.
2. What are the primary competitors to Relistor?
Biosimilars and generic methylnaltrexone bromide versions, as well as competing drugs like naloxegol and naldemedine.
3. What factors influence the drug’s market volume?
Opioid prescribing trends, guidelines for OIC management, and the adoption rates of alternative therapies.
4. How does reimbursement impact market access?
Insurance coverage and prior authorization requirements influence patient access, potentially limiting prescription volume.
5. Are there upcoming regulatory changes that could affect prices?
Monitoring of biosimilar approvals and healthcare reimbursement policies remains crucial, given ongoing policy shifts.
References
- CDC. (2022). Opioid prescribing data. Centers for Disease Control and Prevention.
- IQVIA. (2023). Prescriptions and sales data.
- IQVIA. (2023). Market intelligence reports.
- EvaluatePharma. (2022). Oncology, CNS & Rare Disease Annual Review.
