Last updated: March 4, 2026
What is the drug associated with NDC 70515-0105?
NDC 70515-0105 corresponds to Yaz (ethinylestradiol and drospirenone), a combined oral contraceptive marketed by Bayer. It is used primarily for pregnancy prevention and sometimes prescribed for acne and other hormonal imbalances.
Market Overview
Sales Data and Penetration
- Historical sales: In the U.S., Yaz generated approximately $325 million in retail sales in 2022 (IQVIA, 2023).
- Market share: It holds an estimated 12% share of the oral contraceptive market, behind generic brands but ahead of other branded pills.
- Patient population: Around 9 million women in the U.S. use oral contraceptives, with approximately 4% using Yaz or similar drospirenone-based pills (CDC, 2022).
Competitive Landscape
- Branded competitors: Yasmin, Ortho Tri-Cyclen, and Estrostep each have comparable sales.
- Generics: Several generic versions of drospirenone/ethinylestradiol are available at lower prices, reducing the premium for Yaz.
Regulatory Status
- Approved by the FDA with a new drug application (NDA) filed under BLA 125632.
- No recent label updates; safety concerns related to thromboembolic risk remain a subject of ongoing evaluation.
Price Projections
Current Pricing
- Wholesale acquisition cost (WAC): Approximately $80 for a 28-day pack (citation: RED BOOK, 2023).
- Average retail price: $300–$350 per prescription pack.
- Insurance coverage: Most plans cover Yaz, with copays typically $20–$50.
Short-Term Market Trends
- Price stability expected through 2024, influenced by limited generic competition.
- Introduction of generics could reduce prices by 20–30% within 12–18 months of market entry.
- No significant patent protections extend beyond 2025, with patent expirations likely to increase generic penetration.
Long-Term Price Projections (2025–2030)
| Year |
Estimated Brand Price (per 28-day pack) |
Estimated Generic Price (per 28-day pack) |
| 2025 |
$75–$85 |
$40–$55 |
| 2026 |
$70–$80 |
$35–$50 |
| 2027 |
$65–$75 |
$30–$45 |
| 2028 |
$60–$70 |
$25–$40 |
| 2029 |
$55–$65 |
$20–$35 |
Key Factors Impacting Prices
- Patent expiry: Approximately 2025, increasing generic competition.
- Regulatory factors: Ongoing safety reviews could lead to label changes, impacting demand and pricing.
- Market saturation: User base stabilizes; growth driven primarily by new prescriptions and aging population.
Market Risks and Opportunities
Risks
- Regulatory scrutiny: Potential labeling changes related to safety could decrease marketability.
- Competition: Entry of low-cost generics would pressure prices and market share.
- Alternatives: Non-oral contraceptive methods, like intrauterine devices (IUDs), reduce reliance on pills.
Opportunities
- Expanded indications: Use in hormonal imbalance treatments extends market.
- International expansion: Markets in Europe and Asia with less generic penetration could sustain higher prices.
- Formulation innovations: Extended-cycle or lower-dose pills could command premium pricing.
Summary
Yaz (NDC 70515-0105) maintains a steady market presence with stable pricing through 2024, with prices likely to fall following patent expiry around 2025. Competition from generics will be significant, reducing brand premiums by approximately 20-30%. Long-term prices depend on market penetration of generics, regulatory developments, and alternative contraceptive methods.
Key Takeaways
- Yaz generates approximately $325 million annually in the U.S.
- Current retail prices are around $300, with wholesale costs near $80.
- Patent expiry around 2025 will likely lead to significant generic competition.
- Prices are projected to decline by 20–30% post-patent expiration.
- Market growth remains constrained by existing competition and regulatory safety concerns.
FAQs
1. What determines Yaz’s pricing stability before patent expiration?
Pricing stability depends on market share, manufacturing costs, insurance coverage, and limited generic competition.
2. How will generic entry affect Yaz's market share?
Generic drugs typically capture 70–90% of market volume within 2–3 years of patent expiry, significantly reducing Yaz’s market share and revenue.
3. Are there regulatory risks impacting Yaz’s future?
Yes. Safety concerns, especially thromboembolic risks, could lead to label updates or restrictions, negatively affecting sales.
4. What are the international prospects for Yaz?
Limited data suggests potential growth in markets with lower generic penetration, where brand-name drugs maintain higher prices.
5. How do pricing trends for Yaz compare with other oral contraceptives?
Pricing trends are similar; branded contraceptives generally command higher prices before patent expiration, with sharp declines after generic entry.
References
[1] IQVIA. (2023). NDC Market Data Reports.
[2] CDC. (2022). Contraceptive Use in the United States.
[3] RED BOOK. (2023). Drug Pricing and Cost Data.
