Last updated: February 28, 2026
What is NDC 49348-0305?
NDC 49348-0305 identifies a specific drug product. According to the FDA's National Drug Code directory, this number corresponds to Ulipristal acetate, a selective progesterone receptor modulator used primarily for emergency contraception and preoperative treatment of uterine fibroids.
Market Overview
Therapeutic Use and Indications
- Emergency contraception (EC): As an alternative to levonorgestrel-based pills.
- Uterine fibroids: Prescribed pre-surgery to reduce fibroid size and bleeding.
Market Size and Revenue
- Global market for emergency contraceptives was estimated at over $1.5 billion in 2022 [1].
- U.S. market for fibroid treatments is valued around $1.2 billion annually [2].
Key Competitors
- Levonorgestrel-based EC pills ($20-50 per dose).
- Ella (Ulipristal acetate) in emergency contraception, priced around $50-70 per dose.
- Uterine fibroid treatments include gonadotropin-releasing hormone (GnRH) agonists, priced $800–$2,000 per cycle.
Regulatory Status and Market Penetration
- Approved in the U.S. since 2015.
- Limited by federal and state regulations concerning off-label uses.
- Distribution primarily through specialty pharmacies and select retail pharmacies.
Price Trends and Projections
Current Pricing
- Emergency contraceptive dose: approximately $50–$70 per tablet.
- Preoperative fibroid treatment: estimated at $600–$900 per course.
Manufacturing Costs
- Estimated manufacturing costs for ulipristal acetate are around $10–$20 per tablet, assuming generic formulations are available [3].
Market Drivers Affecting Price
- Patent expiration: No active patent, leading to generic competition.
- Competition: Levonorgestrel products priced 50-80% lower.
- Regulatory restrictions: Limits on off-label uses influence market size.
- Insurance coverage: Still inconsistent; affects out-of-pocket prices.
Price Projections (Next 5 Years)
| Year |
Estimated Market Price (per dose/course) |
Key Factors |
| 2023 |
$50–$70 (EC), $600–$900 (fibroid) |
Current pricing, patent expiry, brand recognition |
| 2024 |
$45–$65 (EC), $550–$850 (fibroid) |
Increased competition, generic entry |
| 2025 |
$40–$55 (EC), $500–$800 (fibroid) |
Further generic proliferation, price compression |
| 2026 |
$35–$50 (EC), $450–$750 (fibroid) |
Market saturation, insurance coverage improves |
| 2027 |
$30–$45 (EC), $400–$700 (fibroid) |
Greater generic penetration, demand stabilization |
Price decline factors
- Entry of generics reduces price by approximately 50%.
- Insurance coverage expansion leads to less out-of-pocket expense.
- Regulatory developments may restrict or expand indications, affecting demand.
Market Dynamics Summary
- The absence of patent protection and entry of generics have already driven prices down from historic highs.
- The primary growth driver remains increased awareness and approval expansion, especially for fibroid treatment.
- Pricing pressure from competing products, notably levonorgestrel-based EC pills, limits upward pricing potential.
- Market size growth depends heavily on regulatory policies and insurance reimbursement trends.
Key Takeaways
- NDC 49348-0305 (ulipristal acetate) operates in highly competitive segments with established generic competition.
- Emergency contraception prices are declining as generics enter the market, expected to reach $30–$50 per dose within five years.
- Preoperative fibroid treatment pricing may decline gradually to below $700 per course.
- Market growth hinges on regulatory developments, insurance coverage, and usage expansion into new indications.
FAQs
Q1: What factors most influence the price of ulipristal acetate?
A1: Patent expiration, generic competition, regulatory restrictions, and insurance reimbursement policies.
Q2: How does the market compare to levonorgestrel-based emergency contraceptives?
A2: Ulipristal acetate generally costs more ($50–$70) and is positioned as a prescription product, whereas levonorgestrel is over-the-counter and cheaper ($20–$50).
Q3: Are there upcoming regulatory changes affecting this drug?
A3: Pending FDA reviews and approvals for expanded indications could impact demand. Changes in labeling may influence market size.
Q4: What is the outlook for insurance coverage?
A4: Coverage is improving, but variability persists. Broader insurance acceptance could lower patient out-of-pocket costs and expand market penetration.
Q5: What are potential development risks?
A5: Regulatory restrictions, competing newer therapies, and patent challenges pose risks to market stability and pricing.
References
[1] MarketWatch. (2022). Emergency Contraceptives Market Size.
[2] Grand View Research. (2022). Uterine Fibroid Market Analysis.
[3] IQVIA. (2022). Cost Estimates for Generic Pharmaceuticals.
