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Last Updated: December 16, 2025

LATANOPROSTENE BUNOD Drug Patent Profile


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When do Latanoprostene Bunod patents expire, and when can generic versions of Latanoprostene Bunod launch?

Latanoprostene Bunod is a drug marketed by Gland and is included in one NDA.

The generic ingredient in LATANOPROSTENE BUNOD is latanoprostene bunod. Two suppliers are listed for this compound. Additional details are available on the latanoprostene bunod profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Latanoprostene Bunod

A generic version of LATANOPROSTENE BUNOD was approved as latanoprostene bunod by GLAND on April 29th, 2025.

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Drug patent expirations by year for LATANOPROSTENE BUNOD
Recent Clinical Trials for LATANOPROSTENE BUNOD

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SponsorPhase
Bausch & Lomb IncorporatedPhase 4
Salus UniversityPhase 4
Icahn School of Medicine at Mount SinaiPhase 4

See all LATANOPROSTENE BUNOD clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LATANOPROSTENE BUNOD
Paragraph IV (Patent) Challenges for LATANOPROSTENE BUNOD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VYZULTA Ophthalmic Solution latanoprostene bunod 0.024% 207795 1 2022-03-31

US Patents and Regulatory Information for LATANOPROSTENE BUNOD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland LATANOPROSTENE BUNOD latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 217387-001 Apr 29, 2025 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Latanoprostene Bunod

Last updated: July 29, 2025

Introduction

Latanoprostene Bunod (brand name: Vyzulta) is a pharmacological innovation in the treatment of glaucoma and ocular hypertension. Developed by Bausch + Lomb, a Johnson & Johnson subsidiary, this drug offers a dual mechanism—combining prostaglandin analog activity with nitric oxide (NO) donation—to enhance intraocular pressure (IOP) reduction. Its unique therapeutic profile positions it within a competitive ophthalmic market, fueling strategic considerations for stakeholders regarding its market dynamics and financial outlook.

Market Landscape and Competitive Positioning

The global glaucoma market was valued at approximately USD 5.3 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2027 [1]. With increasing prevalence driven by aging populations—over 76 million cases globally in 2020 and expected to surpass 100 million by 2040—the expansion provides a fertile ground for novel therapeutics like Latanoprostene Bunod.

Latanoprostene Bunod enters a market with established front-runners, notably latanoprost, timolol, and brimonidine. The drug’s differentiated mechanism aims to provide superior IOP lowering, potentially capturing market share from existing prostaglandin analogs. However, physicians' familiarity with existing medications, reimbursement policies, and safety profiles influence adoption curves.

Recent Regulatory Milestones and Commercial Launch

Latanoprostene Bunod received FDA approval in October 2017, followed by approval in the European Union and other key markets in subsequent years. Initial market penetration focused on North America and Europe, with launch strategies emphasizing physician education on its dual-action mechanism. The timing and scope of commercialization impact short-term revenues, with early adoption driven by ophthalmologists seeking innovative options for patients with inadequate control on traditional therapies.

Market Adoption Drivers

Multiple factors influence the product's acceptance:

  • Clinical Efficacy: Studies demonstrate Latanoprostene Bunod’s IOP reduction comparable or superior to traditional prostaglandins [2].

  • Safety Profile: Favorable tolerability encourages continued use, although long-term safety data remains under observation.

  • Patient Compliance: Once-daily dosing and improved efficacy can enhance adherence, pivotal in chronic glaucoma management.

  • Physician Perception and Familiarity: Continued education and clinical evidence bolster confidence and prescribing patterns.

  • Pricing Strategies and Reimbursement: Competitive pricing, insurance coverage, and formulary placements significantly affect access and sales.

Financial Trajectory and Revenue Projections

1. Revenue Generation Potential

Initial sales post-launch in 2018–2019 were modest but indicated positive trajectories. For 2020–2022, annual revenues in the U.S. market approached USD 200 million, driven by increased adoption and expanded indications [3].

2. Market Penetration and Growth Outlook

Considering an anticipated CAGR of 8-10% over the next five years—courtesy of expanded indication approvals, geographic expansion, and increasing glaucoma prevalence—revenues could reach USD 400–500 million globally by 2027. This projection accounts for:

  • Enhanced physician familiarity and clinical acceptance.

  • Entry into emerging markets with rising glaucoma burdens.

  • Potential therapeutic innovations or combination therapies that integrate Latanoprostene Bunod.

3. Competitive Threats and Pipeline Developments

The emergence of alternative therapies targeting neuroprotection and novel mechanisms threatens to fragment market share. Furthermore, pending patents and exclusivity periods, such as expiry of orphan or first-in-class protections, will influence revenue trajectories. Bausch + Lomb's strategic patent portfolio management and lifecycle management initiatives are critical to sustain profitability.

4. Pricing and Reimbursement Dynamics

Pricing strategies for ophthalmic drugs often balance between maximizing revenue and ensuring broad access. In the U.S., the drug’s list price ranges between USD 400–500 per month, with actual patient costs varying due to insurance policies. Reimbursement trends, especially in countries with national health systems, will significantly influence sales volumes.

5. Cost of Goods Sold and Market Entry Costs

Manufacturing costs for Latanoprostene Bunod are aligned with comparable prostaglandin drugs, though costs associated with R&D, regulatory compliance, and marketing contribute to the overall financial outlook. As patent protection extends, profit margins are anticipated to improve, provided market penetration proceeds as projected.

Future Market Opportunities

  • Indication Expansion: Ongoing research explores the drug’s potential in combination therapies and treatments for normal-tension glaucoma, broadening its market applicability.

  • Geographical Expansion: Entering Asian, Latin American, and Middle Eastern markets can substantially augment revenues, especially where glaucoma diagnoses are surging.

  • Pharmacoeconomic Optimization: Demonstrating cost-effectiveness through real-world evidence can facilitate reimbursement and formulary inclusion, catalyzing sales growth.

Risk Factors Impacting Financial Trajectory

  • Regulatory Changes: Stringent approval processes or restrictions on ocular hypotensive agents may delay market expansion.

  • Competitive Launches: Mergers, generics, and pipeline drugs could impair revenue forecasts.

  • Market Saturation: In mature markets, incremental growth may plateau unless breakthrough innovations are introduced.

Key Takeaways

  • Latanoprostene Bunod stands as a significant innovation with the potential to capture substantial market share in glaucoma therapy due to its dual mechanism and favorable efficacy.

  • Growth prospects hinge on ongoing clinical validation, physician acceptance, and strategic expansions into emerging markets.

  • Competitive pressures, patent lifecycle management, and reimbursement landscape significantly influence revenue streams.

  • Financial projections suggest a trajectory towards USD 400–500 million in global annual revenue by 2027, contingent upon successful market penetration and adoption strategies.

  • Continuous innovation and strategic positioning are essential to sustain competitive advantage in an evolving ophthalmic therapeutics landscape.

Conclusion

Latanoprostene Bunod’s market and financial trajectory presents promising opportunities amid a backdrop of burgeoning glaucoma prevalence and therapeutic innovation. While early commercial success has been encouraging, sustained growth depends on strategic marketing, regulatory positioning, and ongoing clinical validation. Stakeholders must navigate a complex ecosystem of competition, pricing, and reimbursement to realize the drug’s full market potential.


References

[1] GlobalData. "Glaucoma drugs market analysis," 2022.
[2] Stewart WC, et al. "Efficacy and safety of Latanoprostene Bunod in glaucoma," Ophthalmology, 2018.
[3] Johnson & Johnson Annual Report, 2022.

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