Last updated: February 21, 2026
What is the drug associated with NDC 59088-0112?
NDC 59088-0112 designates Oxybutynin Chloride Extended-Release Tablets, 5 mg. The medication is used primarily to treat overactive bladder (OAB), reducing urinary urgency, frequency, and incontinence.
Market size and demand
Current use and prevalence
Overactive bladder affects approximately 33 million adults in the United States. The market for OAB therapeutics predominantly comprises:
- Oxybutynin (extended and immediate-release)
- Tolterodine
- Solifenacin
- Darifenacin
- Trospium
Market share
Oxybutynin holds an approximately 40% market share among OAB prescriptions nationally, with a total annual prescription volume exceeding 10 million units as per IQVIA data (2022). The extended-release formulation accounts for roughly 60% of oxybutynin prescriptions.
Competitive landscape
- Brand names: Ditropan XL (Pfizer), Oxytrol (Gotham), and other generics.
- Generics: Approximately 80% of prescriptions are for generic oxybutynin, including NDC 59088-0112.
Regulatory status
NDC 59088-0112 is a Food and Drug Administration (FDA)-approved generic medication. It has had market clearance since 2004. There are no current major regulatory challenges or recent recalls impacting this specific NDC.
Price analysis and projections
Current pricing
- Average wholesale price (AWP): Approximately $0.28 per 5 mg tablet, according to Red Book and First DataBank (2023).
- Retail price: Typically ranges from $0.35 to $0.55 per tablet depending on pharmacy discounts.
Historical price trend
Over the past five years, prices for generic oxybutynin 5 mg extended-release tablets have remained relatively stable, with minor fluctuations due to market competition and supply chain conditions. No significant upward or downward pricing trend has been observed.
Price projections (next 3–5 years)
Given current market dynamics, the following projections are reasonable:
| Year |
Estimated Price Range per 5 mg Tablet |
Drivers |
| 2023 |
$0.35 – $0.55 |
Competitive generic market, stable demand |
| 2024 |
$0.36 – $0.56 |
Slight inflation, ongoing generic competition |
| 2025 |
$0.37 – $0.58 |
Continued market saturation, potential price erosion |
| 2026 |
$0.38 – $0.60 |
Limited new entrants, stabilization of prices |
Factors influencing future prices:
- Entry of new generic competitors may decrease prices.
- Supply chain disruptions could temporarily impact costs.
- Changes in prescribing patterns or regulatory policies could shift demand.
- Introduction of branded or novel therapies may influence generic pricing.
Market dynamics
Cost considerations
Manufacturing costs for generic oxybutynin are estimated at approximately $0.10–$0.15 per tablet, influenced by raw material prices, manufacturing efficiency, and regulatory compliance.
Reimbursement landscape
Reimbursement rates vary, with Medicare and Medicaid typically reimbursing at levels close to the retail price minus patient copays. Private insurance coverage is widespread, influencing ultimate patient costs.
Strategic considerations
- The aging population increases overall demand.
- Patent expiration on brand-name formulations has facilitated generic market penetration.
- Market saturation limits upward pricing potential.
Summary of key market insights
- The drug faces intense competitive pressure from other generics and branded alternatives.
- Prices have stabilized, with incremental increases aligned with inflation.
- Future price declines are unlikely unless new generic entrants arrive or regulatory policies impose price controls.
- The global market for OAB treatment is expanding, but the U.S. remains the most significant revenue driver.
Key Takeaways
- NDC 59088-0112 is a generic oxybutynin extended-release 5 mg tablet with stable pricing.
- The current market is highly competitive, limiting significant price increases.
- Projected prices stay within $0.36–$0.60 per tablet over the next five years.
- The primary growth driver is demographic expansion rather than pricing power.
- Supply chain and regulatory factors could induce short-term price fluctuations but are unlikely to alter long-term trends.
FAQs
1. How does the price of NDC 59088-0112 compare to other oxybutynin formulations?
It is generally comparable to other generic oxybutynin 5 mg formulations, with slight variations driven by pharmacy discounts and distribution channels.
2. What is the impact of new therapies on this drug’s market?
Novel therapies with improved efficacy or fewer side effects could reduce reliance on oxybutynin, decreasing demand and exerting downward pressure on prices.
3. Are there any upcoming regulatory changes that could affect pricing?
There are no immediate FDA regulations targeting oxybutynin prices, but potential policies limiting drug price inflation could influence margins.
4. How does reimbursement affect actual patient out-of-pocket costs?
Patients typically pay copays, ranging from $10 to $50, depending on insurance plans, which affects revenue collection for manufacturers but has limited impact on wholesale prices.
5. What are the supply risks associated with this NDC?
As a well-established generic, supply disruptions are unlikely; however, manufacturing issues or raw material shortages could cause temporary shortages and price volatility.
References
- IQVIA. (2022). National Prescription Audit.
- First DataBank. (2023). Pricing and Market Data.
- FDA. (2022). Drug Approvals and Market Status.
- Red Book. (2023). Wholesale Drug Pricing Data.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies.
