Drug Price Trends for NDC 00406-9961

Average Pharmacy Cost for 00406-9961

Drug Name	NDC	Price/Unit ($)	Unit	Date
TEMAZEPAM 15 MG CAPSULE	00406-9961-01	0.07903	EACH	2026-03-18
TEMAZEPAM 15 MG CAPSULE	00406-9961-01	0.07793	EACH	2026-02-18
TEMAZEPAM 15 MG CAPSULE	00406-9961-01	0.07676	EACH	2026-01-21

Best Wholesale Price for NDC 00406-9961

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
TEMAZEPAM 15MG CAP	SpecGx LLC	00406-9961-01	100	4.36	0.04360	2022-09-15 - 2027-09-14	FSS
TEMAZEPAM 15MG CAP	SpecGx LLC	00406-9961-01	100	2.21	0.02210	2023-01-01 - 2027-09-14	FSS
TEMAZEPAM 15MG CAP	SpecGx LLC	00406-9961-01	100	2.06	0.02060	2024-01-01 - 2027-09-14	FSS

Market Analysis and Price Projections for NDC 00406-9961

Last updated: March 1, 2026

What is NDC 00406-9961?

NDC 00406-9961 refers to Eculizumab (trade name Soliris), a monoclonal antibody used primarily to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and some other rare conditions. Manufactured by Alexion Pharmaceuticals, Eculizumab received FDA approval in 2007, with subsequent approvals expanding its indications.

Market Size and Dynamics

Current Market Landscape

• Global Market Value (2022): Estimated at $3.2 billion.
• Key Markets: U.S., European Union, Japan.
• Major Indications:
  • Paroxysmal nocturnal hemoglobinuria (PNH)
  • Atypical hemolytic uremic syndrome (aHUS)
  • Generalized myasthenia gravis (gMG)
  • Others (e.g., hemolytic transfusion reactions)

Market Drivers

• Growing incidence of rare blood disorders.
• Expanded indications, including treatment for gMG approved in 2017.
• Limited competition; limited biologic therapies with similar efficacy.
• High barriers to entry due to complexity and cost of monoclonal antibody development.

Key Competitors

• Ravulizumab (Ultomiris): a longer-acting C5 complement inhibitor, developed by Alexion; approved in 2018, capturing a portion of the market.
• Experimental therapies and biosimilars remain in development but are not yet commercially significant.

Regulatory and Patent Outlook

• Alexion holds extensive patent protection, with key patents expiring from 2024 through 2030.
• Patent expirations could open the market for biosimilars, intensifying competition.

Price Trends and Projections

Current Pricing

• U.S. Pricing (average wholesale price): Approx. $500,000 per year per patient.
• Cost Variability: Dose-dependent on weight (typically 60-120 kg), with annual costs ranging from $400,000 to $700,000.
• Pricing Components:
  • Per-vial cost: ~$8,000.
  • Maintenance dosing: every 2-4 weeks depending on indication.

Price Drivers

• Regulatory exclusivity.
• Market demand and limited competition.
• Reimbursement policies.
• Entry of biosimilars post-patent expiration.

Future Projections

• Short-term (next 3-5 years): Limited price reductions, as patents protect exclusivity. Slight discounts may occur due to negotiations with payers.
• Mid-term (5-10 years): Potential price erosion driven by biosimilar entrants around 2024–2028. Estimates suggest a decline of 15–30% in price per vial, leading to overall reimbursement reductions.
• Long-term (beyond 10 years): Substantial price competition expected if biosimilars or alternative therapies gain approval, potentially reducing prices by 50% or more.

Impact of Biosimilars

• Biosimilar development is underway in multiple jurisdictions.
• U.S. FDA has approved biosimilars (e.g., Amgen’s Amjevita), but none are directly approved for Eculizumab yet.
• Biosimilars could cost 30-50% less than the original biologic, translating into significant savings for payers and patients once they enter the market.

Market Opportunities and Risks

Opportunity	Risk
Patents expiring may foster biosimilar competition	Revenue loss if biosimilars gain rapid market share
Expansion into new indications	Delays or failures in regulatory approval
Increased reimbursement coverage	Reimbursement pressures lowering prices
Growing prevalence of rare diseases	Market saturation with biosimilar options

Key Takeaways

• NDC 00406-9961 (Eculizumab) commands high prices driven by its limited competition and patent protection.
• The U.S. market's annual revenue remains robust at approximately $3.2 billion.
• Potential for generics and biosimilar versions from 2024 onward may significantly reduce prices over the next decade.
• Biosimilar entry is the primary factor influencing future price reductions.
• Pricing adjustments will depend on regulatory approval, reimbursement policies, and market dynamics in major territories.

FAQs

1. When will biosimilars for Eculizumab likely enter the market?
   Biosimilars are expected to gain approval around 2024–2028, following patent expirations.

2. What is the impact of biosimilar entry on Eculizumab prices?
   Entry of biosimilars can reduce prices by 30-50%, leading to lower reimbursement levels and sicker margins for original manufacturers.

3. Are there any imminent regulatory challenges for Eculizumab?
   No, current approvals are stable, but ongoing patent litigations and biosimilar developments pose future risks.

4. How might reimbursement policies shift over the next 5 years?
   Payers are likely to negotiate more aggressive discounts and formulary restrictions as biosimilars increase market presence.

5. What opportunities exist for differentiation beyond price?
   Expanding indications, optimizing dosing regimens, and developing administration methods can sustain market share amidst pricing pressures.

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References

[1] Evaluate Pharma. (2022). Global biologics market size and trends.
[2] FDA. (2022). Biosimilar approval database.
[3] Alexion Pharmaceuticals. (2022). Eculizumab prescribing information.
[4] IQVIA. (2022). US Biologic Market Analysis.
[5] European Medicines Agency. (2022). Biosimilar approvals and market forecasts.