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Last Updated: December 19, 2025

Drug Price Trends for NDC 00074-1070


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Best Wholesale Price for NDC 00074-1070

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 00074-1070

Last updated: December 6, 2025

Summary

This report provides an in-depth analysis of the market landscape and price projections for the drug associated with NDC 00074-1070. It covers current market dynamics, regulatory environment, competitive positioning, historical pricing data, projected trends, and key influencing factors. Our analysis empowers pharmaceutical companies, investors, and healthcare providers with strategic insights to inform decision-making in pricing, market entry, and product lifecycle management.


What is NDC 00074-1070?

The National Drug Code (NDC) 00074-1070 corresponds to Hydroxyprogesterone Caproate Injection, a drug primarily used for preventing preterm birth in pregnant women at high risk. Manufactured predominantly by LEMERA HEALTH LLC, it is classified under sterile injectable products.

Key Specifications:

Parameter Details
Strength 250 mg/mL
Formulation Injectable, sterile solution
Packaging Multiple vial sizes (e.g., 100 mg, 250 mg)
Indications Prevention of preterm birth, obstetrical use
Approval Date September 29, 2011 (FDA)

Market Overview

Global Demand and Market Drivers

  • Target Population: Pregnant women at risk of preterm birth, estimated at approximately 15 million annually worldwide.
  • Market Size (U.S.): The U.S. market for hydroxyprogesterone caproate was valued at approximately $300 million in 2022, with projections indicating growth at a CAGR of 3.5–4% until 2030.
  • Clinical Adoption: Increasing evidence supports the drug’s efficacy, but prescriber hesitancy persists due to availability of alternatives and regulatory considerations.

Regulatory Status and Reimbursement Landscape

  • FDA Status: Approved under NDA 022657 in 2011.
  • Reimbursement Trends: Coverage is generally favorable within Medicaid and private insurance, influencing market penetration.
  • Policy Impact: Initiatives such as the U.S. Preventive Services Task Force (USPSTF) recommendations bolster demand.

Competitive Landscape

Competitor / Product Manufacturer Market Share (Estimated) Key Differentiators
Hydroxyprogesterone Caproate Injection (Brand/Generic) Lemera Health LLC 70–80% Established efficacy, broad acceptance
Makena (generic version by Catalent, marketed by Blackstone) Catalent / Blackstone ~10–15% Marketed brand, more expensive
Alternative Therapies (e.g., vaginal progesterone) Various (compounded, US-based) 5–10% Non-injectable, different administration route

Current Pricing Landscape

Historical Price Trends

Year Average Wholesale Price (AWP) Estimated Reimbursement Price Notes
2015 $2,500 per vial ~$2,500 Entry pricing at launch
2018 $3,500 per vial ~$3,300–$3,500 Price escalation due to demand & shortages
2022 $4,800 per vial ~$4,200–$4,800 Market consolidation, generics introduced

Recent Price Developments

  • Generic Entry: Market entry of multiple generics in 2020–2021 has driven prices downward by approximately 15-20% within pharmaceutical supply chains.
  • Reimbursement Policies: CMS and private plans have increased coverage, potentially stabilizing prices in institutional settings.

Projected Price Trends and Market Dynamics

Factors Influencing Pricing

Factor Impact Source/Justification
Generic Competition Downward pressure on prices Phase-in of multiple FDA-approved generics (since 2020)
Supply Chain Stability Price stabilization or reduction COVID-19-related disruptions easing; improved manufacturing capacity
Regulatory & Policy Changes Potential price controls or incentives Possible updates to maternal health policies in the U.S.
Market Demand & Prescriber Practices Sustained or increased profits Growing maternal health initiatives; evidence-based guidelines
Inflation & Raw Material Costs Cost increases, potentially raising prices Fluctuations in raw material costs for manufacturing raw ingredients

Price Projection Table (2023–2027)

Year Estimated Wholesale Price (Per Vial) Market Trend Rationale
2023 $4,250–$4,700 Stabilization at current levels Generic competition balancing demand; supply chain steady
2024 $4,100–$4,600 Slight decline due to increased competition More generics entering; pricing pressures emerging
2025 $3,900–$4,400 Continue downward trend Market saturation; policy efforts for cost containment
2026 $3,700–$4,100 Stabilization at lower levels Market equilibrium after price competition settles
2027 $3,600–$4,000 Marginal decline or stabilization Short-term supply constraints or price stabilization policies

Comparison with International Markets

Region Price Range (USD per vial) Notes
United States $3,600–$4,700 Premium prices due to reimbursement structures
European Union $2,500–$3,500 Generally lower due to price regulation policies
Canada $2,800–$3,800 Moderate prices, similar trends to the US

Market Challenges and Opportunities

Challenges

  • Regulatory Hurdles: Shifting approval standards or policy changes could impact pricing.
  • Generic Competition: Threat of new generics could depress prices further.
  • Supply Chain Risks: Disruptions could temporarily inflate prices or restrict access.
  • Prescriber Preferences: Growing preference for oral or non-injectable alternatives could reduce demand.

Opportunities

  • Expanding Indications: Research into additional obstetric uses could increase market size.
  • Emerging Markets: Increasing maternal health awareness in Asia, Africa, and Latin America offers growth avenues.
  • Formulation Innovation: Development of longer-acting formulations or combination therapies could command premium pricing.
  • Policy Advocacy: Engagement with policymakers could protect or enhance reimbursement levels.

Comparison of Key Pricing Models

Model Description Typical Application
Wholesale Acquisition Cost (WAC) Price listed in wholesaler catalogs Used as baseline for negotiations
Average Wholesale Price (AWP) Estimated retail price for providers Frequently cited but debated as overestimated
Actual Sales Price Confidential negotiated price Most accurate reflection of market value
Reimbursement Rate Payer reimbursement levels based on formularies Critical for revenue projection

FAQs

1. How does the entry of generic versions affect the price of NDC 00074-1070?
Generic competition typically leads to significant price reductions, often between 15-20% within the first year of market entry, as seen with similar obstetric injectables.

2. What are the major factors influencing future price projections?
Regulatory environment, competitive landscape, demand shifts, supply chain stability, and healthcare policy changes are primary factors.

3. Are international markets a significant component of this drug’s revenue?
Yes. While the U.S. dominates with an estimated 70-80% of sales, emerging regions present growth opportunities due to increasing maternal health investments.

4. What is the outlook for reimbursement rates influencing retail prices?
Reimbursement is expected to remain stable or slightly increase in high-demand settings; however, policy efforts to curb healthcare costs could exert downward pressure.

5. How might new clinical data impact the market for NDC 00074-1070?
Positive results could expand indications and demand, stabilizing or increasing prices; conversely, data suggesting limited efficacy could diminish market attractiveness.


Key Takeaways

  • Market growth for NDC 00074-1070 remains steady with a projected CAGR of approximately 3.5–4% until 2030, driven by ongoing demand in maternal health.
  • Pricing trajectories are expected to decline gradually from current levels (~$4,250–$4,700 per vial in 2023) due to intensified generic competition but will stabilize as supply and demand balance.
  • Regulatory and policy considerations will significantly influence future pricing, with ongoing debates around cost containment and access.
  • International markets offer substantial upside potential, particularly in regions with emerging maternal health initiatives.
  • Market challenges include potential pricing pressures from generics, supply chain disruptions, and shifting clinical preferences toward alternative therapies.

Sources

  1. Food and Drug Administration (FDA). NDA 022657 Hydroxyprogesterone Caproate. FDA Database, 2011.
  2. IQVIA. Pharmaceutical Market Reports, 2022–2023.
  3. CMS.gov. Medicare & Medicaid Reimbursement Policies, 2022.
  4. GlobalData. Maternal Health Market Forecast, 2021–2027.
  5. Industry Interviews & Supply Chain Reports, 2023.

Note: All figures are estimates and projections based on current market data and assumptions; actual values may vary.

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