Last updated: February 25, 2026
What is the Drug Identified by NDC 69238-1176?
The National Drug Code (NDC) 69238-1176 corresponds to Linzess (linaclotide), indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation in adult patients. It is marketed by Ironwood Pharmaceuticals and Allergan (now AbbVie, after acquisition).
Market Size and Demand
Current Market Overview
- Estimated US Prescription Volume: Approximately 300,000 dispensed prescriptions annually (IQVIA, 2022).
- Patient Population:
- IBS-C affects 4-5% of US adults.
- Chronic idiopathic constipation affects about 15% of the US population.
- Combined eligible patients approximate 10 million.
- Market Penetration: Penetration rate remains below 15% among eligible patients, indicating room for growth.
Competitive Landscape
- Main competitors include amitiza (lubiprostone), MiraLAX (polyethylene glycol), and Trulance (plecanatide).
- Linzess maintains a market share of roughly 20-25% among prescription drugs for IBS-C and CIC.
Regulatory Status
- Approved in the US since 2012.
- Also approved in Europe and other countries, with varying patent protections.
Patent Landscape
- Patent expiry for the original formulation expected around 2028.
- Patent extensions have been granted in the US, potentially delaying generic entry until 2030.
- Several biosimilar and generic manufacturers are preparing for market entry after patent expiration.
Price Trends and Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately $750 per month for a standard 30-count supply.
- Actual transaction price (after discounts): Roughly $600 per month.
- Insurance Reimbursement: Varies with payers; widely covered with co-pays around $10–$50.
Historical Price Trends
| Year |
Average Monthly Price |
Notes |
| 2012 |
$680 |
First FDA approval |
| 2015 |
$720 |
Slight increase |
| 2018 |
$750 |
Price stabilization |
| 2020 |
$740 |
Slight dip, influenced by insurance trends |
| 2022 |
$750 |
Price plateau |
Future Price Projections
- Post-Patent Expiry (2028–2030): Expected price reduction of 50-70%, aligning with biosimilar/generic entry.
- Short-term (2023–2027): Stable pricing, with minor fluctuations attributable to inflation and market dynamics.
Market Entry Impact
- Entry of generics could reduce prices to approximately $250–$350 per month.
- Biosimilars and increased competition could accelerate price declines.
Economic and Commercial Factors
- Reimbursement pressures may drive formulary shifts, influencing net prices.
- Physician prescribing habits tend to favor branded Linzess, especially among pediatric and high-risk patients.
- New indications or combination therapies under clinical development could expand the market or impact pricing.
Strategic Considerations
- Patent protection delays generic competition until 2028–2030.
- Market share expansion depends on patient access programs and formulary negotiations.
- Price reductions post-patent expiry expected but could vary due to reimbursement policies.
Key Takeaways
- The current U.S. market for Linzess (NDC 69238-1176) remains protein, characterized by steady demand and stable pricing.
- Patent protections limit immediate generic entry, sustaining current prices.
- Price declines anticipated post-2028, with generics potentially reducing monthly costs by half or more.
- Market growth hinges on expanding the eligible patient population and physician adoption.
- Competitive pressures, including biosimilars, will influence long-term pricing trends.
FAQs
1. What are the main factors affecting the price of Linzess?
Pricing is influenced by patent status, generic competition, payer reimbursement policies, market demand, and manufacturing costs.
2. When are generics expected to enter the market?
Patent expiration is projected around 2028, with biosimilar or generic entry likely shortly thereafter, possibly by 2030.
3. How does insurance coverage impact the retail price?
Insurance negotiations and formularies typically reduce the out-of-pocket expense, making the drug more affordable for patients.
4. What is the expected impact of biosimilar entry on market prices?
Biosimilars could cut prices by 50-70%, increasing access but reducing brand revenue.
5. Are there upcoming regulatory or policy changes that could affect pricing?
Any policy favoring biosimilars, affordability initiatives, or patent litigations could influence future pricing dynamics.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2012). Linzess (linaclotide) drug approval documentation.
- FDA. (2022). Patent and Exclusivity Data.
- Scrip, T. (2021). Biopharmaceuticals market report.
- GoodRx. (2023). Prescription drug prices.
