Last updated: March 10, 2026
What Is the Composition and Indication of NDC 00597-0395?
NDC 00597-0395 is the drug Solifenacin Succinate, marketed under the brand name Vesicare. It is indicated primarily for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Solifenacin is a muscarinic receptor antagonist, with typical dosing at 5 mg or 10 mg tablets.
Current Market Position and Competitive Landscape
Market Size and Trends
The global overactive bladder market reached approximately $6 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2028, driven by aging populations and increased diagnosis rates.
Key Competitors
| Drug Name |
Class |
Market Share (2022) |
Notes |
| Vesicare (Solifenacin) |
Muscarinic receptor antagonist |
22% |
Approved since 2004; first-line for OAB |
| Ditropan (Oxybutynin) |
Anticholinergic |
35% |
Older drug, available in multiple formulations |
| Botox (OnabotulinumtoxinA) |
Botulinum toxin |
10% |
Used for refractory cases |
| Mirabegron (Myrbetriq) |
Beta-3 adrenergic agonist |
20% |
Alternative mechanism, growing share |
Prescriber Trends
The preference for Solifenacin has increased due to its favorable side effect profile over older anticholinergics, but generic alternatives and new agents like Mirabegron intensify competitive pressure.
Price and Reimbursement Landscape
Current Pricing
| Product |
Approximate Price (per unit) |
Pricing Notes |
| Vesicare 5 mg |
$400 - $550 per monthly supply |
Brand price; varies by insurer |
| Vesicare 10 mg |
$450 - $600 per monthly supply |
Pricing varies by pharmacy |
| Generic Solifenacin |
$50 - $80 (per monthly supply) |
Available in some regions |
Reimbursement Factors
- Gaining formulary inclusion depends on negotiated rebates.
- Commercial insurers and Medicare Part D cover Vesicare, but competition from generics decreases net price.
Price Trends
Prices for branded Vesicare have decreased approximately 10-15% since patent expiry in 2018. Generic competition has driven prices down, with some plans favoring generics for cost savings.
Patent and Regulatory Status
- Patent Expiry: U.S. patent rights expired in April 2018, opening the market for generics.
- Regulatory Approvals: Approved by FDA since 2004, no recent label updates have been reported that could influence market exclusivity.
Market Entry Barriers and Opportunities
Barriers
- Existing generic competition limits pricing power.
- Established prescriber preferences for other agents.
- Cost-sharing constraints for patients.
Opportunities
- Development of fixed-dose combinations to improve adherence.
- Formulations with improved side effect profiles.
- Focused marketing to urology and primary care physicians.
Price Projection Outlook (2023-2028)
| Year |
Estimated Average Price (per monthly supply) |
Notes |
| 2023 |
$50 - $80 (generics) |
Post-patent expiration |
| 2024 |
$50 - $75 |
Continued generic penetration |
| 2025 |
$45 - $70 |
Higher generic market share |
| 2026 |
$45 - $65 |
Cost pressure, formulary negotiations |
| 2027 |
$40 - $60 |
Further price erosion |
| 2028 |
$40 - $55 |
Stabilization at lower price points |
Key Takeaways
- The market for Solifenacin (NDC 00597-0395) is mature with declining branded prices due to patent expiration.
- Generics dominate, with average prices decreasing by about 20-30% since 2018.
- Competitive landscape favors price-sensitive payers and formulary managers.
- Opportunities include innovation in formulation and positioning for refractory or combination therapies.
- Long-term pricing will likely stabilize near $40-$60 per month, with further price reductions possible if competition intensifies.
FAQs
1. What is the primary competitor to Solifenacin?
Mirabegron (Myrbetriq) is an alternative mechanism that competes directly, alongside older anticholinergics like oxybutynin.
2. How has patent expiry affected Solifenacin pricing?
The expiration has led to an immediate surge in generic options and a corresponding price decrease for branded Vesicare.
3. Are there new formulations of Solifenacin in development?
No current filings or approvals are publicly reported for new formulations specifically for Solifenacin.
4. What are the key factors influencing future pricing?
Market penetration of generics, formulary negotiations, and payer resistance to increasing expenditure influence pricing.
5. What regions are most lucrative for Solifenacin?
The U.S., due to high prevalence of OAB and extensive reimbursement programs, remains the most profitable market, followed by Europe.
References
- Market Research Future. (2022). Overactive bladder market analysis report.
- IQVIA. (2022). U.S. prescription drug market data.
- FDA. (2018). Drug patent expiration notices.
- GoodRx. (2022). Drug price comparison reports.
- EvaluatePharma. (2022). Pharmaceutical market forecasts.
