Last updated: February 22, 2026
What is NDC 00054-4496?
NDC 00054-4496 corresponds to Mifeprex (mifepristone), a desensitizing agent used for termination of early pregnancy and, in combination with misoprostol, medical abortion. It is marketed by Danco Laboratories and primarily used in outpatient settings.
Market Overview
Global and U.S. Market Size
The Mifepristone market has grown significantly since its approval in 2000, driven by increasing acceptance of medical abortion, legislative changes, and expanding access. Key factors:
- U.S. Market: Estimated revenue for Mifeprex was approximately $150 million in 2022, with an annual growth rate around 9% since 2018, according to IQVIA [1].
- Global Market: The global market for medical abortion drugs, including Mifepristone, is projected to reach approximately $580 million by 2027, growing at a CAGR of 8.2% [2].
Key Market Drivers
- Regulatory approval expansions.
- Increasing taboo-breaking policies for access.
- Reduction in surgical procedures.
- Growing healthcare provider adoption.
Major Competitors
- Generic Mifepristone brands in regions with patent expiries.
- Alternative methods like surgical abortion.
- Emerging drugs or combination therapies.
Market Constraints
- Regulatory restrictions and legislative challenges.
- Cultural and political opposition.
- Supply chain issues affecting access and distribution.
Regulatory Environment
U.S. FDA Status
- Since its approval in 2000, Mifeprex has undergone label updates to expand access.
- The FDA approved a REMS (Risk Evaluation and Mitigation Strategy) program, controlling distribution through certified providers.
- Recent regulatory actions include allowing telemedicine for medication abortions in certain states.
International Variations
- Approved in numerous countries, with varying restrictions.
- Some countries have banned or heavily regulated use.
- European approval through the European Medicines Agency (EMA) occurs under different regulatory approvals.
Price Projections
Current Pricing
- In the U.S., wholesale acquisition costs (WAC) per 200-mg tablet: approximately $70.
- A standard medical abortion regimen includes 200 mg of Mifepristone plus misoprostol.
Price Trends and Projections (2023–2028)
Price Comparison with Generics
- Generic Mifepristone available at prices roughly 20-30% lower than branded versions.
- Larger procurement volumes by public health agencies could further reduce prices.
| Year |
Predicted Average Price per 200mg Tablet |
Comments |
| 2023 |
~$70 |
Stable, with minor fluctuations |
| 2024 |
~$67 |
Slight decrease due to generic influx |
| 2025 |
~$65 |
Supply chain efficiencies improve |
| 2026 |
~$60 |
Policy shifts may boost access |
| 2027 |
~$58 |
Increased generic market penetration |
Distribution Channels and Pricing Impact
- In the U.S., distribution is via certified providers and pharmacies.
- Online telehealth providers increasing access may influence distribution costs.
- International markets mainly through government auctions, private clinics, or pharmacy chains, impacting the final consumer price.
Key Market Risks
- Potential legislative restrictions limiting use.
- Disruption in supply chains or manufacturing.
- Rising legal and regulatory costs.
Key Takeaways
- The Mifepristone market is expanding with a compounded annual growth rate of roughly 8% to 9%.
- Prices are trending downwards due to generic entries, with a projected 10-15% decrease over the next five years.
- Regulatory and legislative developments heavily influence market dynamics.
- The global market forecast indicates steady growth, especially in regions with relaxed restrictions.
FAQs
-
What factors influence the price of Mifepristone?
Patent status, generic competition, regulatory policies, and manufacturing costs.
-
How does legislative environment affect market potential?
Restrictions or bans can significantly limit market access, lowering sales volume and prices.
-
What is the expected impact of generics?
Generics have driven prices down by approximately 20-30% and are expected to further pressure brand prices.
-
Are there significant international differences in pricing?
Yes. In countries with regulatory restrictions or procurement constraints, prices can be higher or lower depending on the supply chain and procurement volumes.
-
Can price competition affect drug availability?
Increased price competition can improve access but may reduce profitability for manufacturers, potentially impacting supply stability.
References
[1] IQVIA. (2022). U.S. Pharmaceutical Market Reports.
[2] MarketsandMarkets. (2022). Medical Abortion Drugs Market Size, Share & Trends.
Note: Data are estimates based on market research reports, public financial disclosures, and regulatory filings.
