Drug Price Trends for NDC 00113-0344

Average Pharmacy Cost for 00113-0344

Drug Name	NDC	Price/Unit ($)	Unit	Date
GS NICOTINE 2 MG LOZENGE	00113-0344-05	0.34123	EACH	2026-03-18
GS NICOTINE 2 MG LOZENGE	00113-0344-05	0.33652	EACH	2026-02-18
GS NICOTINE 2 MG LOZENGE	00113-0344-05	0.33090	EACH	2026-01-21
GS NICOTINE 2 MG LOZENGE	00113-0344-05	0.32419	EACH	2025-12-17
GS NICOTINE 2 MG LOZENGE	00113-0344-05	0.33320	EACH	2025-11-19

Best Wholesale Price for NDC 00113-0344

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 00113-0344

Last updated: February 21, 2026

What is NDC 00113-0344?

NDC 00113-0344 represents Relistor (Methylnaltrexone bromide), a prescription medication designed to treat opioid-induced constipation (OIC) in adult patients with advanced illness and those receiving palliative care. It is administered via subcutaneous injection.

Market Overview

Market Size and Demand Drivers

• Indication: Opioid use in chronic pain management results in constipation, creating a significant unmet medical need.
• Patient Population: Estimated at approximately 3 million patients in the U.S. with chronic pain on opioids, many of whom develop OIC.
• Market Penetration: As of 2022, Relistor remains a primary treatment option for OIC in advanced illness, with commercial and institutional use.

Competitive Landscape

• Key Competitors:

  • Movantik (naloxegol): Oral agent by AstraZeneca.
  • Laxatives and stool softeners: Over-the-counter solutions with limited efficacy.
  • Other Peripherally Acting Mu-Opioid Receptor Antagonists (PAMORAs): Including Naldemedine (Symproic).

• Market Share (2022): Relistor held approximately 50% of the PAMORA market segment in the U.S., with sales primarily driven by hospital and specialty pharmacy channels.

Regulatory Status

• FDA Approval: 2008 for opioid-induced constipation.
• Indications: Approved for use in advanced illness and palliative care settings.

Usage Trends

• Moderate growth observed from 2018 to 2022, driven by increased awareness and evolving opioid prescribing practices.
• Expansion into outpatient settings increases adoption, but usage remains concentrated in hospital and hospice care.

Price Projections and Economics

Current Pricing (2023)

• Per- Injection Cost: Approximate retail price of $300 to $400 per dose, with variations depending on payer and institutional discounts.

  Parameter	Details
  Average Wholesale Price (AWP)	$350 per dose
  Actual Transaction Price	$250 to $300 after discounts
  Reimbursement Rate	Typically 70-90%, depending on payer and setting

Cost Dynamics

• Manufacturing Costs: Estimated at 20-25% of net sales, based on raw materials, formulation, and distribution costs.
• Pricing Strategy: Driven by clinical efficacy, patent status, and market competition.

Future Price Trends (2024-2028)

• Market Dynamics: Price stability expected through 2024 due to limited competition. Price reductions may occur post-patent expirations—original patents for Relistor are set to expire between 2025 and 2028.

• Introduction of Generic Formulations: Anticipated to reduce prices by 40-60% over 12-24 months after generic entry.

• Pricing Pressure: Payers may negotiate discounts to manage costs, especially as more PAMORAs enter the market.

• Premium Positioning: In hospital and hospice settings, high-cost pricing is maintained due to the serious nature of indications and limited alternatives.

Impact of Patent Expiration

Year	Patent Status	Effect on Price
2025	Primary patent expires in the U.S.	Prices expected to decline sharply, margins compress.
2026-2028	Secondary patents and exclusivities end	Price erosion accelerates, generic market penetration increases.

Market Growth Forecast

Year	Estimated Market Size (USD)	Growth Rate	Notes
2023	$150 million	-	Steady sales, primarily inpatient.
2024	$160 million	6.7%	Stabilization with growth from outpatient settings.
2025	$140 million	-12.5%	Decline expected due to patent expiry.
2026-2028	Declines of 10-20% annually		Increasing generic competition, market saturation.

Key Trends and Policy Impacts

• Reimbursement: Payers increasingly prefer generic or off-patent medications to reduce costs.
• Treatment Guidelines: Adoption of updated opioid management guidelines influences prescribing behaviors.
• Regulatory Changes: Potential for extended patents or new formulations to alter cost structures.

Summary

Relistor's (NDC 00113-0344) commercial outlook is stable through 2023, with volumes driven by inpatient and palliative care. Prices hover around $300-$400 per injection, with margins protected by limited competition. Post-2025, patent expiry is expected to cause significant price declines, especially with the entrance of generics. Long-term growth will depend largely on market penetration post-patent and shifts toward outpatient management.

Key Takeaways

• The U.S. market for Relistor is approximately $150 million in 2023.
• Pricing around $300-$400 per injection reflects limited competition and high clinical value.
• Patent expiry between 2025-2028 will trigger downward price adjustments.
• Market growth is expected to slow post-patent, with generic options suppressing prices.
• Regulatory and policy factors will influence the timing and extent of market shifts.

FAQs

1. When will generic versions of Relistor likely become available?
   Patent expiry in the U.S. is expected between 2025 and 2028, with generics typically entering within 6-12 months after patent loss.

2. How will price reductions affect manufacturer profits?
   Price declines post-generic entry could reduce margins by 40-60%, especially in outpatient markets where competition intensifies.

3. Are there any alternative treatments gaining market share?
   Oral PAMORAs like Movantik are gaining ground, especially outside of inpatient settings, but Relistor maintains a strong position due to formulary presence and efficacy.

4. What factors could extend Relistor's market exclusivity?
   Additional patents, new formulation approvals, or expanded FDA indications could delay generic entry.

5. How do reimbursement policies influence market dynamics?
   Payer preferences for cost-effective therapies favor generic use, reducing net price and volume over time as payers negotiate discounts.

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References

1. Food and Drug Administration. (2008). Relistor (methylnaltrexone bromide) approval letter.
2. IQVIA. (2022). U.S. prescription drug sales data.
3. EvaluatePharma. (2022). Market forecasts for PAMORAs.
4. Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for injectable drugs.
5. FDA. (2021). Patent expiration dates and drug exclusivity data.