Last updated: February 27, 2026
What Is NDC 70000-0477?
NDC 70000-0477 corresponds to Vyzulta (latanoprostene bunod) 0.024% ophthalmic solution, developed by Bausch + Lomb. It was approved by the FDA in June 2017 for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Market Overview
Drug Indications and Usage
- Main indication: Glaucoma and ocular hypertension.
- Competition: Primarily other prostaglandin analogs such as latanoprost (Xalatan), bimatoprost (Lumigan), tafluprost (Zioptan), and travoprost (Travatan Z).
Market Size & Growth
- The global market for glaucoma treatments was valued at approximately $4.3 billion in 2021.
- Compound annual growth rate (CAGR): 3.8% projected through 2026 (Market Research Future, 2022).
- US market share: Estimated to be around 35%-40% of total glaucoma medication sales.
Competitive Landscape
- Top-selling prostaglandin analogs: Xalatan (Pfizer), Lumigan (Allergan/AstraZeneca), Travatan Z (Alcon).
- Vyzulta’s position: Niche, differentiated by dual mechanism (NO donation and prostaglandin activity) offering potential IOP reduction advantages.
Adoption Rate
- Early adoption: Moderate, due to recent approval and existing competition.
- Prescriber familiarity: Limited, as general ophthalmologists tend to stick with established drugs initially.
Price Point Analysis
Current Pricing
- Average wholesale acquisition cost (WAC) for Vyzulta: approximately $600 to $700 per 2.5 mL bottle.
- Market penetration: Lower than established drugs initially; recent data suggest increased prescribing as awareness grows.
Price Comparison
| Drug |
Average WAC (per bottle) |
Year of FDA approval |
Market Penetration |
| Vyzulta (NDC 70000-0477) |
$650 |
2017 |
Growing |
| Xalatan (Latanoprost) |
$250 |
1996 |
Dominant |
| Lumigan (Bimatoprost) |
$300 |
2001 |
Significant |
| Travatan Z (Travoprost) |
$250 |
2006 |
Moderate |
Pricing Dynamics
- Vyzulta has a premium pricing, justified by dual mechanism offering, but faces pressure from lower-cost alternatives.
- Rebates and discounts may lower net prices.
- Future price increases depend on formulary access and prescriber acceptance.
Revenue Projections
Short-term (1-3 years)
- Limited market penetration due to competition.
- Estimated US sales: $50 million to $100 million in 2023.
Medium-term (4-5 years)
- Increased adoption with clinician familiarity.
- Projected US sales: $120 million to $200 million by 2026.
Long-term (Beyond 5 years)
- Global expansion potential.
- Possible price stabilization or slight decrease due to biosimilar and generic competition.
Regulatory and Market Factors Affecting Pricing
- Patent exclusivity: Patents extend until at least 2032, protecting pricing power.
- Generics: No generic version available yet; could influence pricing post-expiry.
- Insurance coverage and formularies: Pivotal in uptake; branded drugs tend to secure limited formulary presence early on.
Key Takeaways
- NDC 70000-0477 (Vyzulta) occupies a niche market with premium pricing driven by unique dual-action mechanism.
- Market penetration remains moderate but improves as prescriber familiarity increases.
- Short-term revenue forecasts remain conservative, with a potential to surpass $200 million annually in the US by 2026.
- Price pressure will mount with the entry of generics post-patent expiration, potentially halving prices.
- Global expansion and formulary inclusion will significantly influence long-term revenue and pricing strategies.
FAQs
What factors influence Vyzulta’s market penetration?
Clinician familiarity, formulary inclusion, competitive landscape, and insurance coverage.
How does Vyzulta’s pricing compare to other glaucoma drugs?
It is approximately 2-3 times higher than older prostaglandin analogs like latanoprost, reflecting its newer, dual-action profile.
What is the patent status for Vyzulta?
patents protect Vyzulta until at least 2032, with exclusivity influencing pricing power.
Are there generic alternatives available?
No; generics are not available yet but may enter the market post-patent expiry.
What are the primary drivers of future sales growth?
Prescription familiarity, global expansion, formulary acceptance, and potential for combination therapies.
References
- Market Research Future. (2022). Global glaucoma drugs market report.
- U.S. Food and Drug Administration. (2017). Approval of Vyzulta.
- IQVIA. (2022). Pharmaceutical market data.
- EvaluatePharma. (2022). Global ophthalmology drug sales forecast.
- Bausch + Lomb. (2023). Product information: Vyzulta.
