Last updated: February 15, 2026
What is the current market landscape for NDC 62559-0251?
NDC 62559-0251 refers to Fesoterodine fumarate, marketed under brand names such as Toviaz by Pfizer. It is prescribed for overactive bladder (OAB). Since its FDA approval in 2008, the drug has experienced steady demand driven by increasing awareness of OAB and expanded indications.
How does the current market size compare to historical data?
The U.S. OAB drug market, led by anticholinergic agents like fesoterodine, had sales approaching $1.5 billion in 2022 (IQVIA). Fesoterodine accounts for roughly 15-20% of this market, with annual sales near $300 million. The drug’s market share is constrained by generic competition and emerging therapeutics like beta-3 adrenergic agonists.
What are the key factors influencing price trends?
Patent status and exclusivity
Fesoterodine's patent protection expired in 2017. The loss of exclusivity opened the market to generic versions, leading to significant price reductions. The brand-name drug previously sold at an average wholesale price (AWP) of $750–$850 per month per patient. Generics lowered prices to $300–$400 per month, markedly reducing revenue for branded sales.
Entry of generics
Multiple generic manufacturers entered markets post-2017. Their prices stabilized around $250–$350 per month, depending on pharmacy and insurance negotiations. Price erosion continues as more generics enter, aligning prices across various formulations.
Market penetration and biosimilars
While no biosimilars exist for fesoterodine, new therapies entering the OAB space influence pricing dynamics. Drugs like mirabegron (a beta-3 agonist) began capturing market share, diluting fesoterodine's dominance.
What are projections for future pricing?
Short-term (1-2 years)
Brand-name prices are unlikely to return unless patent issues re-emerge or new formulations offer clinical advantages. Generics are expected to stabilize prices near $250–$300 per month for the foreseeable future.
Medium-term (3-5 years)
Adoption of newer drugs could further displace fesoterodine, pushing prices downward. The increasing use of combination therapies and potential new entrants could sustain price competition. A likely average price for existing generics will hover around $200–$300 per month.
Long-term (beyond 5 years)
If patent rights are reestablished or if innovation or combination approaches prove superior, there could be brief periods of price stabilization at higher levels. However, pervasive generic presence constrains revival of prices for fesoterodine.
What are the competitive pressures that could impact pricing?
- Entry of new therapeutic agents such as beta-3 receptor agonists (mirabegron), which gained FDA approval in 2012 and became dominant in the OAB market.
- Development of combination therapies and extended-release formulations targeting better efficacy or side effect profiles.
- Increased adoption of digital therapeutics which may modify prescribing behaviors.
- Generic competition remains the primary force suppressing fesoterodine prices.
How do pricing trends for fesoterodine compare with comparable drugs?
| Drug |
Original Brand Price (per month) |
Generic Price Range (per month) |
Year of Patent Expiry |
| Fesoterodine (Toviaz) |
$750–$850 |
$250–$350 |
2017 |
| Oxybutynin |
$60–$100 |
$15–$40 |
2010 |
| Tolterodine |
$100–$150 |
$30–$50 |
Patent expired in 2014 |
| Mirabegron (Myrbetriq) |
$400–$500 |
$250–$350 |
2012 |
This comparison shows a typical pattern: brand prices significantly higher than generics, with dramatic reductions post-patent expiry.
What are the key takeaways?
- The U.S. fesoterodine market has declined sharply since patent expiry, with generic prices now stabilizing.
- Market share shifts toward newer drugs, especially beta-3 adrenergic agents.
- Future pricing will depend on therapeutic competition, patent litigation or reformulation strategies, and clinical differentiation.
- Pricing for fesoterodine is unlikely to return to pre-2017 levels absent new formulation or patent protections.
FAQs
What factors could cause a price rebound for fesoterodine?
Patent reissues, new formulations demonstrating superior effectiveness, or legal challenges could temporarily raise prices. However, repeated patent litigation or generic market penetration typically prevent sustained price increases.
How does market competition influence the price of fesoterodine?
The presence of multiple generics drives prices down. Entry of alternative therapies shifts prescribing patterns, diminishing the brand’s market share and revenue, which pressures residual brand pricing.
Are biosimilars relevant to fesoterodine?
No, fesoterodine is a small molecule; biosimilar concept does not apply. Generic versions are the primary competition.
How might policy changes affect future prices?
Regulatory moves favoring biosimilar or generic entry, or changes in patent law, could accelerate price erosion or extend exclusivity, respectively.
What is the impact of new OAB treatments on fesoterodine pricing?
New therapeutic options, especially beta-3 agonists, are replacing fesoterodine, reducing market share and limiting pricing power.
References
- IQVIA. "U.S. Prescription Drug Market Summary," 2022.
- FDA. “Fesoterodine fumarate” product approval details, 2008.
- FDA. “Mirabegron (Myrbetriq),” approval date 2012.
- GoodRx. “Fesoterodine (Toviaz) Prices,” 2023.
- Statista. “Overactive bladder market size in the U.S.,” 2022.
