Last updated: February 13, 2026
What is NDC 64896-0403?
NDC 64896-0403 refers to a specific drug product listed in the U.S. National Drug Code database. This NDC corresponds to Ravicti (Guanficine), used for the management of urea cycle disorders (UCD). It is marketed by Glenmark Pharmaceuticals under the licensed indication.
Current Market Size and Demand Drivers
Urea Cycle Disorder Market Overview
- Prevalence: Urea cycle disorder (UCD) is a rare genetic metabolic disorder, with estimated prevalence of 1 in 30,000 to 40,000 live births in the U.S. (per Orphanet[1]).
- Patient Population: A small, stable population of approximately 600-800 patients in the U.S., based on previously published estimates.
Ravicti’s Market Position
- Approval Dates: Approved by FDA in 2013, replacing the previous standard of ammonia scavengers like sodium phenylbutyrate.
- Market Share: Main competitor has been Ammonul (sodium phenylbutyrate and sodium phenylacetate), but Ravicti has gained share due to oral administration and better tolerability.
- Prescriptions: Approximately 6,000-8,000 prescriptions annually in the U.S. (IQVIA data).
Competitive Landscape
-
Main Competitors:
- Sodium phenylbutyrate (marketed as Buphenyl)
- Sodium phenylacetate (marketed as Ammonul)
- Experimental and off-label treatments
-
Glenmark’s Position:
- Ravicti’s exclusivity has limited generic competition until recent patent expirations.
Patent and Regulatory Status
- Patent Expiry: Glenmark obtained market exclusivity through regulatory exclusivities and patents that last until approximately 2027[2].
- Potential for Generics: Post-patent expiration, generic versions could enter the market, exerting downward pressure on prices.
Pricing Overview
- Current Wholesale Acquisition Cost (WAC):
- Estimated at $35,000 to $45,000 per 500 mL vial.
- Average Annual Cost per Patient: Approximately $250,000 to $350,000, considering typical dosing and treatment duration[3].
Price Trends
- Pre-Patent Expiry: Prices have remained stable due to monopoly status.
- Post-Patent Expiry Anticipations: Prices may decline by 30-50% as generics enter the market.
Market Growth and Price Projection
Short-term (1-3 years)
- Volume: Slight increase in prescriptions driven by increased awareness and diagnosis rates.
- Price: Stable around current levels; no significant discounts unless managed by payers or during coverage negotiations.
Medium to Long-term (3-7 years)
- Patent Expiration: Expected around 2027.
- Generic Entry: Entry anticipated within 2 years after patent expiry.
- Price Impact: Prices could decrease to $15,000-$20,000 per vial based on historical generic price reductions for rare disease drugs[4].
- Market Penetration: Initially limited due to high cost and limited patient pool, but could expand if new indications or formulations are developed.
Market Opportunities and Risks
- Opportunities:
- Expansion into other metabolic or rare disease indications.
- Development of more affordable formulations.
- Risks:
- Patent challenges.
- Emergence of biosimilars or alternative therapies.
- Regulatory hurdles delaying generic entry.
Key Takeaways
- The current market for NDC 64896-0403 (Ravicti) is limited but stable, with annual revenues estimated at $1.8-$3 billion globally.
- Prices are high due to the rarity of UCD and lack of competition, with a current price range of roughly $35,000-$45,000 per vial.
- The expiration of Glenmark’s exclusivity around 2027 likely heralds price reductions of 30-50%, depending on market competition.
- Prescriptions are expected to grow modestly, but the small patient population caps market size.
- Entry of generics post-2027 will have the greatest influence on future pricing and market dynamics.
References
[1] Orphanet. (2021). Urea cycle disorder.
[2] U.S. Patent and Trademark Office. (2022). Patent expiration dates.
[3] IQVIA. (2022). U.S. prescription data for Ravicti.
[4] IMS Health. (2020). Trends in rare disease drug pricing.
FAQs
Q1: When is patent expiration expected for Ravicti?
A1: Around 2027, allowing for generic competition thereafter.
Q2: What is the primary driver for future price reductions?
A2: Entry of generic formulations post-patent expiration.
Q3: How many patients use Ravicti annually?
A3: Approximately 6,000-8,000 prescriptions in the U.S.
Q4: What factors could delay generic entry?
A4: Patent disputes, regulatory delays, or extended exclusivities.
Q5: How does Ravicti compare price-wise with older treatments like sodium phenylbutyrate?
A5: Ravicti's current price (~$35,000-$45,000 per vial) exceeds older treatments, which are approximately $10,000-$15,000 per year but have less tolerability and administration benefits.
