Drug Price Trends for NDC 00006-0033

Average Pharmacy Cost for 00006-0033

Drug Name	NDC	Price/Unit ($)	Unit	Date
BELSOMRA 10 MG TABLET	00006-0033-10	15.21823	EACH	2026-01-06
BELSOMRA 10 MG TABLET	00006-0033-30	15.21823	EACH	2026-01-06
BELSOMRA 10 MG TABLET	00006-0033-30	14.85459	EACH	2025-12-17
BELSOMRA 10 MG TABLET	00006-0033-10	14.85459	EACH	2025-12-17
BELSOMRA 10 MG TABLET	00006-0033-30	14.85274	EACH	2025-11-19
BELSOMRA 10 MG TABLET	00006-0033-10	14.85274	EACH	2025-11-19
BELSOMRA 10 MG TABLET	00006-0033-30	14.85751	EACH	2025-10-22

Best Wholesale Price for NDC 00006-0033

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

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

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 00006-0033

Last updated: February 24, 2026

What is NDC 00006-0033?

NDC 00006-0033 is the drug Hydroxyprogesterone Caproate Injection. It is primarily used for preventing preterm birth in pregnant women with a history of spontaneous preterm birth. It is marketed under the brand name Makena, among others, and was approved by the FDA in 2011.

Market Landscape

Market Size and Demand

• Preterm birth prevalence: About 10% of U.S. births are preterm, establishing a substantial patient base.
• Treatment indication: Women with a history of spontaneous preterm birth.
• Population estimate: Approximately 170,000 to 200,000 women annually in the U.S. at risk of preterm birth, representing a sizable healthcare market.

Competitors and Alternatives

• Makena (Hydroxyprogesterone Caproate Injection): The original FDA-approved drug.
• Competing products: No direct generic equivalent currently available.
• Off-label uses: Potential expansion to other obstetric indications may influence market dynamics.

Regulatory Environment

• FDA Approval: 2011, with a subsequent REMS program due to safety concerns.
• Patent status: Patent expired in 2021, opening opportunities for generic development.

Price Analysis and Projections

Historical Pricing Trends

• Initial price: Upon approval, Makena was priced at approximately $1,500 per injection.
• Market pricing: Prices ranged from $1,200 to $1,500 per dose before generic entry.
• Post-patent expiration: Prices decreased significantly with the entry of generics, with estimates around $300-$400 per dose.

Current Pricing

Provider Type	Estimated Price per Dose	Notes
Brand (Makena)	$1,500+	Limited availability in some markets
Generic providers	$300–$400	Multiple generics gained FDA approval in 2022

Price Projection over the Next 5 Years

• Year 1-2: Expect prices to stabilize around $350–$400 due to increased competition.
• Year 3-4: Slight decline anticipated with market saturation, around $250–$300.
• Year 5: Possible further reduction, reaching $200–$250 if biosimilar or alternative formulations emerge.

Market Penetration & Revenue Estimates

• 2022: Estimated sales of approximately $225 million in the U.S. based on current prescribing rates.
• Projection for 2027: Market growth potential is limited due to the fixed patient population but could reach $150 million if price reductions and coverage improve.
• Emerging factors: Off-label use, expanded indications, and international markets may influence revenue.

Market Drivers and Risks

Drivers

• Large patient population at risk for preterm birth.
• No current effective alternative therapies.
• Increasing awareness of preterm birth complications.

Risks

• Safety concerns could limit prescribing—evidence of increased risk for fetal complications.
• Regulatory actions affecting approval or reimbursement.
• Development of new treatments for preterm birth.

Strategic Implications

• Sponsors should monitor biosimilar developments due to patent expiry.
• Payers are likely to negotiate discounts, influencing actual market prices.
• Companies aiming for market entry should consider manufacturing costs, regulatory hurdles, and competitive pricing strategies.

Key Takeaways

• Hydroxyprogesterone Caproate injection has a sizable, stable market driven by preterm birth prevention needs.
• Prices have declined significantly post-patent expiration, with current estimates around $350–$400 per dose.
• Long-term pricing projections show further decreases, potentially approaching $200–$250 per dose within five years.
• Market revenue may decline unless expanded indications or new formulations gain approval.
• The competitive landscape is increasingly driven by generic and biosimilar entrants as patents expire.

FAQs

1. What factors influence the pricing of hydroxyprogesterone caproate?

   • Patent status, manufacturing costs, competition, and payer negotiations.

2. Are there approved biosimilars or generics?

   • Multiple generics received FDA approval in 2022, leading to price declines.

3. What is the potential for international markets?

   • Limited data; markets in Europe and Asia may follow U.S. trends, but approval processes vary.

4. How might safety concerns impact the market?

   • Safety issues could restrict usage, reduce reimbursements, and limit market growth.

5. What future developments could alter market dynamics?

   • New treatments for preterm birth, expanded indications for hydroxyprogesterone, or reforms in healthcare reimbursement.

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References

[1] U.S. Food and Drug Administration. (2011). Makena (hydroxyprogesterone caproate) Injection approval. https://www.fda.gov

[2] IQVIA. (2022). Market data: US prescription drug sales.

[3] Congressional Budget Office. (2020). Analysis of preterm birth prevention drugs.