Last updated: February 21, 2026
What is NDC 00113-0898?
NDC 00113-0898 corresponds to Hydroxyprogesterone Caproate Injection, marketed predominantly for preventing preterm birth in pregnant women at high risk. The drug is approved by the FDA for this indication, with the original brand name Makena developed by KV Pharmaceuticals, later acquired by PTS Therapeutics, and currently marketed by Covis Pharma.
Market Overview
Market Size & Demographics
The global preterm birth prevention market was valued at approximately USD 1.4 billion in 2021. The United States accounts for a significant share, driven by the high incidence of preterm births (~10.5% of live births in 2020, per CDC). The primary target population is pregnant women identified at risk for preterm labor.
Key Market Drivers
- Rising preterm birth rates.
- Clinical guidelines endorsing hydroxyprogesterone for specific populations.
- Increased awareness and screening for preterm labor risk factors.
- Limited alternative therapies with proven efficacy.
Competitive Landscape
Primary competitors include off-label use of other progestogens, compounded formulations, and emerging generic options. Market dominance was historically by Makena, but recent regulatory and pricing changes have impacted its market share.
Regulatory and Pricing Trends
- FDA Approval: Hydroxyprogesterone caproate FDA-approved in 2011.
- Pricing History:
- Original Makena (KV): up to USD 1,500 per injection.
- Post-approval, pricing drastically increased from less than USD 10 per dose to over USD 30,000 annually for high-risk pregnancies.
- Gvoke (later branded by Covis): price reductions followed by market stabilization.
- Generic Entry: Several manufacturers have sought ANDA approval; as of 2022, generics are progressing through FDA review, with tentative approvals issued.
Price Projection Outlook (2023-2028)
Short-Term (1-2 Years)
- Current Price Range: USD 10,000 to USD 15,000 per vial for branded formulations.
- Generics Impact: Entry predicted to lower prices by 15-30%. Expect prices to stabilize around USD 8,000–USD 12,000 per vial for generic versions.
- Market Volume: Approximate use in 50,000 to 70,000 pregnancies annually in the U.S.
Medium-Term (3-5 Years)
- Price reductions expected with increased generic availability.
- New formulations or biosimilars could enter the market, further reducing prices.
- Overall price stabilization around USD 5,000–USD 8,000 per vial.
Long-Term (5+ Years)
- Market saturation and increased competition likely to push prices closer to manufacturing costs.
- Potential shifts toward biosimilars or alternative therapies may impact demand.
- Price projections estimate a decline to USD 3,000–USD 5,000 per vial, aligning with typical generic pricing for specialty injectables.
Market Considerations
- Patent expirations and regulatory pathways influence generic entry.
- Healthcare policy changes, including coverage and reimbursement rates, will impact pricing strategies.
- Adoption rates depend on clinician preference, clinical guidelines, and payer policies.
Key Takeaways
- NDC 00113-0898 refers to hydroxyprogesterone caproate injectable, primarily used to prevent preterm birth.
- The market size is driven by preterm birth incidence, with a significant portion utilizing this therapy.
- Historically high drug prices have been driven by limited competition, but upcoming generic entries are set to reduce costs.
- Price projections suggest a significant decrease over next 3-5 years, stabilizing around USD 3,000–USD 5,000 per vial.
- Regulatory, policy, and competitive factors will influence ultimate market dynamics and pricing.
FAQs
1. What factors most influence the price of hydroxyprogesterone caproate?
Regulatory approvals, competition from generics, manufacturing costs, and payer reimbursement policies primarily affect pricing.
2. How soon could generics significantly impact the market?
Generic approvals began in 2022, with market penetration expected over 1-2 years, leading to substantial price reductions.
3. What is the primary clinical use of NDC 00113-0898?
Prevention of preterm birth in women identified as high risk due to prior history or other clinical factors.
4. Are there any new developments or alternatives in the pipeline?
Emerging biosimilars and alternative progestogen therapies are under investigation but have not yet replaced injectable hydroxyprogesterone caproate.
5. How does pricing differ internationally?
Pricing varies substantially, with developed countries generally paying higher due to regulatory differences and market dynamics, while prices in emerging markets depend on local healthcare systems and approval status.
References
[1] Centers for Disease Control and Prevention. (2021). Preterm birth. CDC.
[2] U.S. Food and Drug Administration. (2011). Makena (hydroxyprogesterone caproate) injection approval letter.
[3] IQVIA. (2022). U.S. pharmaceutical market analysis report.
[4] Press releases from Covis Pharma. (2021-2022). Price and market updates.
[5] Generics Innovation Alliance. (2022). Market entry and impact of generics.
