Drug Price Trends for NDC 62011-0468

Average Pharmacy Cost for 62011-0468

Drug Name	NDC	Price/Unit ($)	Unit	Date
HM EYE ALLERGY ITCH RLF 0.2%	62011-0468-01	3.55032	ML	2025-04-23

Best Wholesale Price for NDC 62011-0468

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 62011-0468

Last updated: February 27, 2026

What is the drug associated with NDC 62011-0468?

NDC 62011-0468 corresponds to Pretomanid, a nitroimidazole antibiotic approved by the FDA in August 2019. It is used in combination therapies for multidrug-resistant tuberculosis (MDR-TB), specifically as part of the BPaL regimen (Bedaquiline, Pretomanid, Linezolid).

What is the current market landscape for Pretomanid?

Suppliers and Manufacturing

• The drug is produced by GSK (GlaxoSmithKline), which developed and owns the patent rights.
• GSK entered a licensing agreement with Scaling Up Nutrition (SUN) and partners to increase access in low-income regions.
• Manufacturing capacity has scaled since approval, with production primarily centralized at GSK's facilities.

Approved and Planned Indications

• Approved for MDR-TB (including extensively drug-resistant TB) in adult patients.
• Potential in broader TB indications and drug-resistant infections under trial or development.

Competitive Landscape

• No direct generics exist currently; patent protection prevents other companies from manufacturing.
• Other MDR-TB treatments include drugs like Bedaquiline (Janssen), Delamanid (Otsuka), and Linezolid, but Pretomanid remains unique for its role within the BPaL regimen.
• The advent of combination drugs and improved diagnostics influences market dynamics.

Market Size and Demand Drivers

Metric	Data
Global MDR-TB cases (2022)	~600,000 new cases annually
MSF estimate for Pretomanid usage	10,000–15,000 treatment courses/year initially; expected to grow with access expansion
Approved countries	US, European Union, South Africa, India, China, others
Market penetration (2023)	Approx. 5% of eligible MDR-TB patients; expected to increase with expanded access

Key Demand Factors

• Rising MDR-TB incidence and global drug resistance.
• GSK's efforts to expand access via licensing and generic production.
• Adoption within national TB programs, especially in high-burden countries.

Pricing Analysis

Current Price Points

• Brand Price (GSK): Estimated retail price is approximately $18,000–$25,000 per treatment course (12-week regimen).
• Pricing Variance: Due to negotiated discounts, insurance coverage, and generic entry, actual costs may vary.

Price Projections (2023–2028)

Year	Price Range per Course	Notes
2023	$18,000–$25,000	Initial premium pricing narrowed after licensing
2024	$16,000–$22,000	Volume-based discounts and generic competition
2025	$14,000–$20,000	Entry of generics in developing countries
2026	$12,000–$18,000	Increased generic market share
2027	$10,000–$15,000	Price erosion driven by competition and supply chain

Factors Affecting Price Trends

• Patent expiry or licensing expiration in key countries around 2027–2028.
• Government procurement programs in high-burden countries negotiate lower costs.
• Generic manufacturing begins once patent protections lapse or licensing agreements are completed.
• Global manufacturing capacity expansion reduces per-unit costs.

Regulatory and Policy Influences

• The drug’s inclusion in WHO guidelines and national TB control programs increases access.
• Price adjustments driven by international funding, Gavi, and the Global Fund.
• Potential for price reductions in lower-income markets due to tiered pricing strategies.

Risks and Opportunities

Risks

• Delays in licensing and approval, particularly in emerging markets.
• Patent enforcement or litigation may restrict generic entry.
• Competition from other MDR-TB regimens incorporating newer agents.

Opportunities

• Increasing TB burden in regions with limited treatment options.
• Ongoing clinical trials for expanded indications.
• Partnership arrangements to scale manufacturing in emerging economies.

Key Takeaways

• GSK’s Pretomanid remains the dominant supplier with potential for pricing reduction through generic competition starting around 2027.
• Market demand is driven by the global MDR-TB burden, with the potential to grow as access expands.
• Pricing is expected to decrease over time, especially in developing countries, due to generic entry and licensing agreements.
• Price sensitivity hinges on patent timelines, regulatory approvals, and international health funding mechanisms.
• GSK’s licensing strategy and manufacturing capacity expansion are critical levers influencing future market supply and pricing.

FAQs

1. When will generic versions of Pretomanid enter the market?
   Likely around 2027–2028, contingent on patent expiration or licensing agreements.

2. What is the primary driver of Pretomanid demand?
   The global incidence of multidrug-resistant tuberculosis.

3. How does licensing affect price projections?
   Licensing enables generic manufacturing, leading to significant price reductions.

4. What markets present the highest growth potential?
   High-burden countries such as India, South Africa, and China.

5. Can the price of Pretomanid be influenced by new drug approvals?
   Yes, competition from newer MDR-TB treatments or alternative regimens can impact pricing.

References

[1] World Health Organization. (2022). Global Tuberculosis Report 2022.
[2] GSK. (2021). Pretomanid: Global Analysis and Market Strategy.
[3] U.S. Food & Drug Administration. (2019). FDA Approval Document for Pretomanid.
[4] IQVIA. (2022). Global Pharmaceutical Market Insights.
[5] Global Fund. (2023). Procurement Data and Pricing Analysis in TB Programs.