Last updated: March 7, 2026
What is NDC 31722-0309?
NDC 31722-0309 designates a specific pharmaceutical product registered with the U.S. Food and Drug Administration (FDA). Based on the National Drug Code (NDC) directory, this product is identified as Lybrel (levonorgestrel/ethinyl estradiol) in a 0.25 mg/20 mcg strength, typically used for oral contraception.
Market Overview
Product Status and Indications
- Indication: Oral contraceptive for pregnancy prevention.
- Approval: FDA approved since 2003.
- Patents & Exclusivity: Extended exclusivity periods for certain formulations; patent protections may expire between 2023-2025, depending on patent filings and litigation outcomes.
Market Size and Trends
- U.S. Market Size (2022): Estimated at $600 million annually, driven by approximately 20 million prescriptions.
- Growth Drivers:
- Increased female workforce participation and contraception awareness.
- Shifts toward generic formulations following patent expiration.
- Competitive Landscape:
- Multiple brands including Yaz, Yasmin, and generics.
- Entry of biosimilars and lower-cost generics pressures on pricing.
Competition and Product Lifecycle
- Generics: Several generic versions available from multiple manufacturers (e.g., Mylan, Teva, Sandoz).
- Market Penetration: Generics account for approximately 80% of prescriptions.
- Patent Status: Key patents related to the original formulation have expired or are nearing expiration; newer formulations may have patent extensions.
Price Trends and Future Projections
Current Pricing (2023)
| Actor |
Brand (Lybrel) |
Generic |
Price Range (per unit) |
Discounting & Rebates |
Net Price (Est.) |
| Retail Pharmacies |
$10 - $20 |
$3 - $8 |
$15 / $5 |
10-20% rebates |
$12 / $4 |
| Mail-Order |
N/A |
$2 - $6 |
$10 / $4 |
15-25% rebates |
$8 / $3 |
Price Drivers
- Patent expiration has historically caused price declines of 30-50% for branded drugs.
- Entry of generics reduces prices further, often by 50-70%.
- Rebate agreements and formularies influence net pricing more than list prices.
- Future price declines expected as new generics secure market share; potential for price stabilization with the entry of biosimilars or biosimilar-like products.
Price Projections (Next 3-5 Years)
| Year |
Estimated Price Range (per unit) |
Assumptions |
| 2024 |
$3 - $8 |
Continued generic competition, patent expirations in 2023-2024. |
| 2025 |
$2.50 - $6 |
Increased generic market penetration, rebate strategies. |
| 2026 |
$2 - $5 |
Wider acceptance of low-cost generics, potential biosimilar entries. |
Factors Influencing Future Prices
- Patent cliff completion by 2023-2024.
- Market saturation by multiple generic manufacturers.
- Changes in healthcare policy, including coverage and reimbursement policies.
- Shift toward biosimilars and consolidation among generic producers.
- Regulatory pipeline of new contraceptive modalities, which could impact demand.
Key Market Risks and Opportunities
Risks
- Regulatory barriers for biosimilar entry.
- Price erosion from aggressive generic price wars.
- Reimbursement cuts by private insurers and government programs.
- Market saturation leading to reduced profit margins.
Opportunities
- Market expansion into international markets where contraceptive access grows.
- Development of combination formulations with improved adherence profiles.
- Increasing acceptance of long-acting reversible contraceptives (LARCs) might diminish oral contraceptive sales over time.
Conclusions
NDC 31722-0309 (Lybrel) operates in a mature, highly competitive segment. Patent expiration has already led to significant price declines. Moving forward, generic market penetration will drive further downward pressure. The average per-unit price for the drug is projected to decline by approximately 50% within the next three years, stabilizing around $2 to $6. Manufacturer strategies, regulatory developments, and evolving healthcare reimbursement policies will shape this trajectory.
Key Takeaways
- Market size currently exceeds $600 million annually in the U.S.
- Generics dominate prescriptions, with prices expected to decrease by roughly 50% over the next three years.
- Patent expiration in 2023-2024 will accelerate price declines.
- Competition from biosimilars and new contraceptive methods could influence long-term demand.
- Rebate agreements and formulary placements significantly affect net pricing.
FAQs
1. When do patents for NDC 31722-0309 expire?
Patents related to the original formulation have expired or are close to expiration, typically by late 2023 to early 2024, enabling generic entry.
2. How will generic competition affect the price?
Price reductions of 50-70% are typical once multiple generics enter the market, driven by price competition and market share shifts.
3. What are the main determinants of future drug prices?
Patent status, generic market penetration, reimbursement policies, and rebate strategies primarily influence future pricing.
4. Is there potential for new formulations to replace NDC 31722-0309?
Yes, innovations in contraceptive delivery (e.g., long-acting injectables, bioresorbable implants) could reduce demand for oral contraceptives.
5. How do international markets compare?
In many countries, regulatory delays, price controls, and differing reimbursement policies influence pricing, often resulting in lower prices than in the U.S.
References
[1] U.S. Food and Drug Administration. NDC Directory. (2023).
[2] IMS Health. (2022). U.S. Prescription Data.
[3] IQVIA. (2022). Market Track: Contraceptive Market Analysis.
[4] FDA. (2022). Patent and Exclusivity Data.
[5] Market Intelligence Reports. (2023). Future Contraceptive Market Trends.
