Drug Price Trends for NDC 13811-0303

Average Pharmacy Cost for 13811-0303

Drug Name	NDC	Price/Unit ($)	Unit	Date
PHENOBARBITAL 100 MG TABLET	13811-0303-10	0.21734	EACH	2026-03-18
PHENOBARBITAL 100 MG TABLET	13811-0303-50	0.21734	EACH	2026-03-18
PHENOBARBITAL 100 MG TABLET	13811-0303-10	0.21934	EACH	2026-02-18

Best Wholesale Price for NDC 13811-0303

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: 13811-0303

Last updated: February 23, 2026

What is the drug associated with NDC: 13811-0303?

The NDC 13811-0303 corresponds to Ravicti (glycerol phenylbutyrate), a prescription drug used to reduce ammonia levels in patients with)**urea cycle disorders). It is marketed by Hyperion Therapeutics, now part of BioMarin Pharmaceutical.

What is the current market landscape?

Market Size and Demand

• The global hyperammonemia treatment market was valued at approximately USD 60 million in 2021.
• The urea cycle disorder (UCD) segment is a niche market with an estimated prevalence of 1 in 35,000 live births.
• UCD cases are primarily diagnosed within infancy and early childhood.

Key Competitors

• Ravicti (glycerol phenylbutyrate) — approved in 2013.
• Buphenyl (sodium phenylbutyrate) — traditional alternative, approved in 1990.

Market Share Dynamics

• Ravicti held approximately 75% of the hyperammonemia market in 2022 due to ease of administration and dosing schedule.
• Buphenyl remains relevant, especially in regions with limited access to newer therapies.

Regulatory Status

• Ravicti approved by FDA in 2013.
• Orphan drug designation granted, supporting exclusivity through 2028.
• Priority review and orphan status reduce competition delay.

What factors influence future pricing?

Factors Impacting Price Setting

• Orphan drug status provides market exclusivity, enabling premium pricing.
• Market penetration depends on diagnosed prevalence and clinician awareness.
• Manufacturing costs stay relatively stable due to specialized production.
• Competitive dynamics from existing therapies and emerging treatments.

Historical Pricing Data

Year	Approximate Wholesale Acquisition Cost (WAC) per 30 Days	Notes
2013	USD 15,000	Initial launch price
2018	USD 17,000	Slight increase, inflation-adjusted
2022	USD 20,000	Market stabilization

Price trends reflect market exclusivity and inflation.

What are projections for future pricing?

Short-term (2023–2025)

• With patent protection remaining until 2028, expect stabilization or slight increments.
• Price per 30 days likely between USD 20,000 to USD 22,000.
• Payers may resist significant hikes, but high treatment cost remains standard for rare disease drugs.

Medium-term (2026–2030)

• Possible price increases of 2–3% annually to offset inflation.
• Entrances of biosimilars or generics unlikely before 2028 due to orphan exclusivity.
• Price may shift depending on new competitors or formulations.

Long-term (post-2028)

• After market exclusivity expires, generic versions could reduce prices by 50% or more.
• Discounted pricing could emerge, especially in managed care contracts.
• New or alternative therapies could further influence pricing strategies.

Implications for stakeholders

• Manufacturers: Maintain patent protection to sustain premium pricing.
• Payers: Negotiate coverage agreements given high costs.
• Investors: Consider pricing stability due to orphan status, with potential for volume growth based on increasing diagnosis rates.

Key Takeaways

• Ravicti is a niche orphan drug with steady demand driven by the prevalence of urea cycle disorders.
• The market size remains limited but profitable, with pricing around USD 20,000 per month.
• Patent protection and orphan drug designations support sustained premium pricing through 2028.
• Future price increases are expected to be modest, with significant discounts likely following patent expiration and generic entry.

FAQs

1. What factors could lead to price reductions for Ravicti?
   Patent expiration in 2028 and potential entry of biosimilars/generics would decrease prices significantly.

2. How does orphan drug status influence pricing?
   It grants market exclusivity, enabling higher prices to recover R&D costs and fund limited patient populations.

3. Are there competing therapies in development?
   Yes. Several investigational therapies aim to improve ammonia detoxification, potentially impacting Ravicti's market share.

4. What is the global market outlook for glycerol phenylbutyrate?
   The global market is growing slowly due to diagnosis challenges and limited awareness, but regional expansion could elevate demand.

5. How might policy changes affect Ravicti pricing?
   Increased regulatory pressure or changes to orphan drug incentives could impact pricing stability and market access.

---

References:

[1] U.S. Food and Drug Administration (FDA). (2013). Ravicti (glycerol phenylbutyrate) approval letter.
[2] IQVIA. (2022). Pharmaceutical Market Reports.
[3] BioMarin. (2022). Annual Report.
[4] GlobalData. (2022). Hyperammonemia Treatment Market Analysis.