Latanoprostene bunod - Generic Drug Details

What are the generic sources for latanoprostene bunod and what is the scope of freedom to operate?

Latanoprostene bunod is the generic ingredient in two branded drugs marketed by Gland and Bausch And Lomb, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprostene bunod has fifty-three patent family members in thirty-eight countries.

Two suppliers are listed for this compound.

Summary for latanoprostene bunod

International Patents:	53
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	6
Patent Applications:	492
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for latanoprostene bunod
What excipients (inactive ingredients) are in latanoprostene bunod?	latanoprostene bunod excipients list
DailyMed Link:	latanoprostene bunod at DailyMed

Recent Clinical Trials for latanoprostene bunod

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

Sponsor	Phase
Bausch & Lomb Incorporated	Phase 4
Salus University	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 4

See all latanoprostene bunod clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for latanoprostene bunod

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	AB	RX	Yes	Yes			Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	AB	RX	Yes	Yes			Y	Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	AB	RX	Yes	Yes				Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017	AB	RX	Yes	Yes			Y	Y

Expired US Patents for latanoprostene bunod

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017

International Patents for latanoprostene bunod

Country	Patent Number	Title	Estimated Expiration
Costa Rica	8498	DERIVADOS DE PROSTAGLANDINAS
Ukraine	84726	ПРОИЗВОДНЫЕ ПРОСТАГЛАНДИНОВ, СПОСОБ ИХ ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ ГЛАУКОМЫ ИЛИ ГИПЕРТЕНЗИИ ГЛАЗА;ПОХІДНІ ПРОСТАГЛАНДИНІВ, СПОСІБ ЇХ ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ ГЛАУКОМИ АБО ГІПЕРТЕНЗІЇ ОКА (PROSTAGLANDIN DERIVATIVES, PROCESS FOR THE PREPARATION THEREOF, PHARMACEUTICAL COMPOSITION (VARIANTS) AND METHOD FOR THE TREATMENT OF GLAUCOMA AND OCULAR HYPERTENSION)
Denmark	1704141
Spain	2566800
China	1906159	Prostaglandin nitrooxyderivatives
Poland	1704141

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.

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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.