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
21922-0048 Market Analysis and Financial Projection
The drug corresponding to NDC 21922-0048 is Nitroglycerin Ointment 0.4%, a topical vasodilator used to treat moderate-to-severe pain from chronic anal fissures. Market analysis and projections for this product are informed by broader trends in the anal fissure treatment and topical drug markets:
Market Overview
Global Anal Fissure Treatment Market
Valued at $1.38 billion in 2023, the market is projected to reach $1.96 billion by 2029, growing at a 6.2% CAGR[15][16].
Topical nitrates (e.g., nitroglycerin ointment) dominate this segment due to their non-invasive application, efficacy in pain relief, and cost-effectiveness compared to surgical options[15].
Nitroglycerin Ointment’s Role
Nitroglycerin ointment reduces anal sphincter pressure, relieving pain and promoting healing. Clinical trials show a 44 mm mean reduction in pain scores (VAS scale) over 3 weeks, outperforming placebo[14].
It faces competition from botulinum toxin injections and surgical therapies but remains a first-line treatment for acute cases[15][16].
Competitive Landscape & Pricing Factors
Market Size for Nitroglycerin Ointment
The annual addressable U.S. market for nitroglycerin ointment is $19.9 million as of 2023[18].
Generic Competition
In July 2023, Acrux Limited filed an ANDA for a generic version of nitroglycerin ointment, signaling future price pressure as generics enter the market[18].
Current Manufacturers
Major suppliers include Encube Ethicals Private Limited (NDC 21922-0048) and Zydus Pharmaceuticals (NDC 70771-1717)[14][13].
Price Projections
Short-Term (2024–2026)
With the pending FDA review of Acrux’s generic application, brand-name nitroglycerin ointment prices may stabilize or decline slightly to retain market share.
Average U.S. wholesale prices for branded formulations are estimated at $50–$70 per 30g tube (current pricing not explicitly stated in sources).
Long-Term (2027–2030)
Generic entrants could reduce prices by 20–30%, mirroring trends in other topical drug markets[8][18].
Growth in the topical drug delivery market (6.3% CAGR to 2031)[4] and anal fissure treatment demand (6.2% CAGR)[15] may offset price erosion, sustaining revenue growth for manufacturers.
Regional Insights
North America leads due to high healthcare spending and prevalence of gastrointestinal disorders[15][16].
Asia-Pacific is the fastest-growing region, driven by improving healthcare access and rising awareness of anal fissure treatments[7][15].
Key Risks
Side Effects: Headache and hypotension from systemic absorption may limit patient adherence[10][14].
Regulatory Hurdles: Strict FDA requirements for generic bioequivalence could delay competitor launches[18].
Conclusion
Nitroglycerin Ointment 0.4% (NDC 21922-0048) is positioned in a steadily growing market, though generic competition and therapy alternatives will shape its pricing trajectory. While short-term prices may dip post-generic entry, long-term demand from expanding topical drug applications supports stable revenue growth.
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