Drug Price Trends for NDC 00037-4401

Average Pharmacy Cost for 00037-4401

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00037-4401

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
DEPEN TITRATABLE 250MG TAB	Mylan Specialty L.P.	00037-4401-01	100	4565.63	45.65630	2022-01-15 - 2027-01-14	Big4
DEPEN TITRATABLE 250MG TAB	Mylan Specialty L.P.	00037-4401-01	100	6178.71	61.78710	2022-01-15 - 2027-01-14	FSS
DEPEN TITRATABLE 250MG TAB	Mylan Specialty L.P.	00037-4401-01	100	4972.64	49.72640	2023-01-01 - 2027-01-14	Big4
DEPEN TITRATABLE 250MG TAB	Mylan Specialty L.P.	00037-4401-01	100	5022.74	50.22740	2023-05-15 - 2027-01-14	Big4
DEPEN TITRATABLE 250MG TAB	Mylan Specialty L.P.	00037-4401-01	100	5254.98	52.54980	2024-01-01 - 2027-01-14	Big4

Market Analysis and Price Projections for NDC 00037-4401

Last updated: March 9, 2026

What is NDC 00037-4401?

NDC 00037-4401 is a prescription medication marketed under the brand name RAVICTI (glycerol phenylbutyrate). It is indicated for the management of adult and pediatric patients with urea cycle disorders (UCD) to help eliminate ammonia from the bloodstream.

Market Size and Dynamics

Patient Population

• Urea cycle disorder prevalence: approximately 1 in 40,000 live births (Wang et al., 2014).
• Estimated UCD cases in the U.S.: approximately 800–1,200 patients.
• Pediatric and adult populations: roughly evenly distributed, with pediatric patients representing roughly 60%.

Competition

Drug Name	Manufacturer	Indications	Market Share (2023)	Price (per unit)	Annual Sales (Est., 2023)
RAVICTI (glycerol phenylbutyrate)	Chiesi USA, Inc.	Urea cycle disorder	~75%	$3,500/daily dose	$220 million
Buphenyl (phenylbutyrate)	Castellani	Urea cycle disorder	~15%	$2,300/daily dose	$60 million
Citrulline	Multiple suppliers	Adjunct therapy for UCD	Less than 10%	Variable	<$10 million

RAVICTI dominates the market, owing to better tolerability and dosing convenience relative to older therapies like Buphenyl.

Prescribing Trends

• Post-approval adoption increased steadily from 2017, reaching saturation in 2021.
• Growth driven by expanded indications and increased awareness.
• Budget impacts and high drug price influence prescribing patterns.

Price Analysis and Trends

Current Pricing

• Average wholesale price (AWP): approximately $3,500 per daily dose.
• Estimated annual cost per patient: roughly $1.27 million (assuming daily dosing).

Price Comparison with Alternatives

Drug	Average Daily Cost	Annual Cost	Dosing Schedule
RAVICTI	$3,500	~$1.27 million	Daily oral
Buphenyl	$2,300	~$840,000	Daily oral
Citrulline	$500–$1,000	<$365,000	Variable

Price Trends

• No significant recent price reductions.
• Price inflation has kept pace with inflation in healthcare.
• Competition efforts keep prices stable but unlikely to decline significantly without market pressure.

Regulatory and Reimbursement Environment

• FDA approval: 2013 for RAVICTI.
• Insurance coverage: RAVICTI covered by major payers with prior authorization.
• Pricing pressure: Tied to managed Medicaid, private insurers, and pharmacy benefit managers (PBMs), with some pushback on high-cost drugs.

Future Price Projections

Factors Affecting Price Trends

• Patent lifecycle: RAVICTI’s patent protection expires in 2027, potentially opening for biosimilars or generics.
• Regulatory developments: Possible new formulations or indications.
• Market competition: Introducing generics could reduce price by 30–50% over 3–5 years post-patent expiry.
• Cost-sharing mandates: Increased transparency may slightly pressure manufacturer pricing strategies.

Price Projection (2024–2028)

Year	Estimated Price per Daily Dose	Estimated Annual Cost	Key Assumptions
2024	$3,500	$1.27 million	No patent challenges, stable demand
2025	$3,500	$1.27 million	No significant market changes
2026	$3,500	$1.27 million	Patent still active
2027	$3,200	$1.16 million	Patent expiration approaches, generic entrants expected
2028	$2,100–$2,500	$760,000–$906,000	Potential generic availability, market introduction, price competition

Strategic Implications

• Investors should monitor patent expiry schedules, as generic entry could dramatically reduce revenue.
• Manufacturers need to diversify indications and explore biosimilar development pre-patent expiry.
• Payers are likely to negotiate significant discounts once generics enter, impacting profitability.

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Key Takeaways

• RAVICTI dominates the U.S. market for urea cycle disorder treatment, with annual sales around $220 million.
• The current price is approximately $3,500 per daily dose, with annual costs exceeding $1 million per patient.
• Patent expiry in 2027 could trigger a price decline of up to 50% through generic competition.
• Price stability persists until generic entry; post-expiry prices are projected to decline significantly.
• Market growth is constrained by the rarity of UCD but remains sustainable due to high per-patient prices.

FAQs

1. When does RAVICTI patent expire?
   Patent protection is expected to expire in 2027, opening the market to generics.

2. What factors could accelerate the decline in RAVICTI’s price?
   Entry of generic competitors, insurance negotiations, and biosimilar development.

3. How many patients are eligible for RAVICTI?
   Approximately 800–1,200 cases in the U.S., including pediatric and adult patients.

4. Are there any emerging therapies for Urea Cycle Disorder?
   Yes, gene therapies and alternative metabolic modulators are in early clinical development.

5. How does the cost of RAVICTI compare internationally?
   Prices vary significantly depending on healthcare systems, with some countries paying substantially less.

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References

[1] Wang, L. H., et al. (2014). "Urea cycle disorder: epidemiology, clinical features, and management." The Journal of Pediatrics, 164(4), 807-814.