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Last Updated: March 27, 2026

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

Identify potential brand extensions & 505(b)(2) entrants

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: February 15, 2026

Latanoprostene bunod is a nitric oxide-donating prostaglandin F2α analog approved for lowering intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. The drug competes in a crowded ophthalmic therapeutics market, driven by the increasing prevalence of glaucoma, regulatory pathways, and competitive landscape.

Market Overview

The global glaucoma therapeutics market was valued at approximately USD 4.0 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6% from 2023 to 2030, reaching USD 6.0 billion. Drivers include aging populations in North America, Europe, and parts of Asia, with an estimated 80 million people affected worldwide.

Latanoprostene bunod, marketed as Vyzulta by Bausch + Lomb (a division of Bausch Health), was approved by the FDA in October 2017. It offers a dual mechanism: lowering IOP by increasing uveoscleral outflow (via prostaglandin analog activity) and relaxing vascular smooth muscle (via nitric oxide donation).

Competitive Position

Latanoprostene bunod faces competition from established prostaglandin analogs such as latanoprost, bimatoprost, and travoprost. Key differentiators include its novel nitric oxide (NO) component, which aims to improve efficacy in patients with inadequate response:

  • Latanoprost (marketed since 1996): Dominates with approximately 60% market share.
  • Bimatoprost and travoprost: Hold significant portions, with established safety profiles.
  • New entrants and generics: Emerge as patent exclusivity diminishes.

In 2022, Vyzulta generated approximately USD 30 million in revenues, representing a modest share relative to the overall market. The market share is limited but has growth potential, particularly among patients unresponsive to traditional therapies.

Market Penetration and Adoption Challenges

Barriers include:

  • Pricing: Vyzulta commands a premium over generics, limiting adoption in cost-sensitive segments.
  • Awareness: Education regarding NO-donating agents is still evolving among clinicians.
  • Regulatory and reimbursement constraints: Variability across markets impacts sales growth.

Financial Trajectory

Forecasting revenues involves multiple factors:

Factor Impact
Regulatory approvals in additional markets Expected to expand sales beyond North America, Asia-Pacific, and Europe.
Patent life and exclusivity period Patent protection extends until 2035, supporting long-term sales.
Competitive launches Introduction of generics post-patent expiry could compress prices.
Expansion into combination therapies Collaborations and development of fixed-dose combinations may enhance market share.

Analysts predict that, absent major market disruptions, Vyzulta's revenues could grow at a CAGR of 8-12% from 2023 to 2028, reaching USD 50-70 million by 2028. Growth will depend on successful physician education, formulary acceptance, and expanding geographic footprint.

Factors Influencing Future Revenues

  • Market penetration: Targeted strategies to increase utilization among refractory cases.
  • Pricing strategies: Adjustments to improve access in competitive payor environments.
  • Pipeline development: Investigating combination therapies or new indications to diversify revenue streams.
  • Patent and regulatory landscape: Monitoring for patent challenges and pending approvals in emerging markets.

Risks and Opportunities

Risks:

  • Patent challenges or generic competition post-2035.
  • Slow adoption due to physician preference for established therapies.
  • Regulatory delays or unfavorable reimbursement policies.

Opportunities:

  • Expanding into second-line treatments for glaucoma.
  • Developing combination formulations for improved compliance.
  • Broadening geographic presence, especially in emerging markets.

Key Takeaways

  • Latanoprostene bunod occupies a niche in a mature glaucoma market, with limited current revenue but growth prospects.
  • Market penetration depends heavily on education, cost management, and geographic expansion.
  • Revenues are projected to grow at a steady pace through 2028, subject to competitive and regulatory dynamics.
  • The patent expiry in 2035 and ongoing pipeline developments present both risks and strategic opportunities.

FAQs

1. What differentiates latanoprostene bunod from other glaucoma medications?
It donates nitric oxide, potentially improving efficacy in lowering IOP compared to traditional prostaglandin analogs.

2. When will generic versions of Vyzulta likely appear?
Patent expiry is expected around 2035, after which generics may enter the market, exerting downward pressure on pricing.

3. How does the market growth outlook look for glaucoma drugs overall?
The market is projected to grow 6% annually until 2030, driven mainly by aging populations and increasing disease prevalence.

4. What are the major barriers to Vyzulta’s wider adoption?
Pricing, clinician awareness, and formulary placement are significant barriers.

5. Are there plans for pipeline expansion for latanoprostene bunod?
Development efforts focus on combination therapies and new indications, which could enhance future revenue streams.

Citations:

[1] "Glaucoma Drugs Market Size, Share & Trends Analysis Report," Grand View Research, 2023.
[2] "Vyzulta (latanoprostene bunod) Prescribing Information," Bausch & Lomb, 2017.
[3] "Global Glaucoma Therapeutics Market Forecast 2023-2030," MarketsandMarkets, 2023.

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