VYZULTA Drug Patent Profile

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

Vyzulta is a drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in thirty-eight countries.

The generic ingredient in VYZULTA 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 Vyzulta

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

Summary for VYZULTA

International Patents:	53
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	2
Patent Applications:	223
Drug Prices:	Drug price information for VYZULTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYZULTA
What excipients (inactive ingredients) are in VYZULTA?	VYZULTA excipients list
DailyMed Link:	VYZULTA at DailyMed

See drug prices for VYZULTA

Recent Clinical Trials for VYZULTA

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

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	Phase 4
University of California, San Diego	N/A
Bausch & Lomb Incorporated	N/A

See all VYZULTA clinical trials

Paragraph IV (Patent) Challenges for VYZULTA

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 VYZULTA

VYZULTA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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

Expired US Patents for VYZULTA

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

International Patents for VYZULTA

When does loss-of-exclusivity occur for VYZULTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Intellectual Property Organization (OAPI)

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VYZULTA around the world.

Country	Patent Number	Title	Estimated Expiration
Costa Rica	8498	DERIVADOS DE PROSTAGLANDINAS
Canada	2551409	NITRO-OXY-DERIVES DE LA PROSTAGLANDINE (PROSTAGLANDIN NITROOXYDERIVATIVES)
Italy	MI971440

Market Dynamics and Financial Trajectory for VYZULTA

Last updated: July 27, 2025

Introduction

VYZULTA (latanoprostene bunod) is a notable addition to the ophthalmic therapeutics landscape, approved by the U.S. Food and Drug Administration (FDA) in November 2017 for the reduction of intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT). As a first-in-class nitric oxide (NO)-donating prostaglandin analog, VYZULTA's unique mechanism offers a potential advantage in glaucoma management—a leading cause of irreversible blindness globally. This analysis explores the intricate market dynamics influencing VYZULTA's commercial trajectory, its competitive positioning, and the financial outlook based on current trends and regulatory developments.

Market Landscape and Therapeutic Need

Glaucoma affects over 80 million individuals worldwide, with projections indicating an increase to approximately 112 million by 2040 due to aging populations [1]. The established therapeutic approach involves lowering IOP to slow disease progression, primarily through prostaglandin analogs, beta-blockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, and Rho kinase inhibitors.

Despite the availability of multiple treatment options, challenges persist: approximately 30-50% of patients exhibit suboptimal IOP control, poor adherence due to complex regimens, and adverse effects limiting therapy acceptability [2]. Consequently, there is a substantial unmet need for innovative therapies that demonstrate improved efficacy, safety, and patient adherence.

VYZULTA, by virtue of its NO donation promoting additional aqueous humor outflow, aims to address these unmet needs and carve a significant niche within the glaucoma therapeutic space.

Market Dynamics Influencing VYZULTA

Competitive Landscape

VYZULTA competes primarily with well-established prostaglandin analogs such as LUMIGAN (bimatoprost), TRAVATAN (travoprost), and XALATAN (latanoprost). These brands dominate global prescriptions owing to their proven efficacy and long-standing clinicalUse. However, over the past decade, the landscape has shifted with introducing drugs with novel mechanisms and improved tolerability.

VYZULTA faces direct competition from other NO-donating or combination therapies, including:

• Rho kinase inhibitors like netarsudil (Rhopressa), approved in 2017, which increase trabecular outflow.

• Combination therapies such as Rocklatan (netarsudil and latanoprost), offering dual mechanisms.

While VYZULTA's mechanism is unique, its market penetration depends on demonstrating improved outcomes over existing prostaglandins and combination therapies, particularly in patients with inadequate IOP control.

Regulatory and Clinical Evidence Impact

The clinical trials leading to VYZULTA’s approval demonstrated statistically significant reductions in IOP, comparable to other prostaglandins but with a distinct mode of action [3]. Post-approval, efficacy and safety data will influence prescriber preferences and formulary decisions. Positive real-world evidence can catalyze uptake, especially if VYZULTA exhibits superior tolerability or efficacy in resistant cases.

Market Adoption Factors

• Physician prescribing habits: Ophthalmologists tend to favor familiar prostaglandins; promotion efforts are crucial.
• Patient adherence: VYZULTA’s dosing schedule of once daily is comparable to other prostaglandins, favoring compliance.
• Cost and reimbursement: As a branded medication, pricing strategies, insurance coverage, and patient out-of-pocket costs are instrumental in adoption.

Pricing and Reimbursement Considerations

Pricing strategies must balance profitability with competitive positioning. Historically, branded glaucoma therapies often command premiums, but payor pushback can restrict access. VYZULTA’s success hinges on demonstrating cost-effectiveness aligned with its clinical benefits.

Financial Trajectory and Revenue Forecast

Initial Launch Performance

Since its 2017 approval, VYZULTA's commercial trajectory has been moderate. AbbVie, the manufacturer, employed targeted marketing and strategic partnerships to boost prescriber awareness. Market penetration remained constrained in the initial years, partly due to competition and the conservative prescribing habits of ophthalmologists.

Growth Catalysts

• Expansion of approved indications: VYZULTA has received orphan drug status for certain indications, enhancing its market exclusivity.
• Post-market studies: Data confirming superior safety or efficacy could accelerate penetration.
• Combination formulations: Development of fixed-dose combinations could improve convenience and adherence, increasing sales.

Market Penetration and Revenue Projections

Industry analysts estimate that VYZULTA's sales could reach approximately $200-300 million globally by 2025, contingent on successful market adoption, reimbursement landscape, and absence of unforeseen safety concerns [4]. The drug’s revenue growth will likely mirror similar prostaglandin analogs’ trajectories, with an accelerated phase once prescriber familiarity improves, and formulary coverage expands.

Risks and Challenges

• Market saturation: With multiple established therapeutics, VYZULTA’s incremental benefit must be compelling.
• Pricing pressures: Payers may restrict access or negotiate discounts.
• Generic competition: While branded therapies benefit from patent protection, biosimilar or generic formulations in the future could impact market share.

Regulatory and Pipeline Developments Impacting Financials

Ongoing clinical trials exploring VYZULTA's use in combination therapies or for other ocular conditions could diversify revenue streams. Regulatory approvals for additional indications or supportive data could bolster sales prospects.

Conclusion

VYZULTA’s market dynamics reflect a complex interplay of clinical efficacy, competitive positioning, payer strategies, and physician adoption behavior. While initial sales have been modest, the drug holds potential for growth driven by its novel mechanism, favorable dosing schedule, and ongoing clinical development. The financial trajectory depends heavily on overcoming market entry barriers, demonstrating clear advantages over competitors, and establishing comprehensive reimbursement pathways.

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Key Takeaways

• Market Opportunity: With glaucoma prevalence projected to rise, VYZULTA addresses significant needs in IOP management, especially for patients unresponsive to existing therapies.
• Competitive Edge: Its NO-donating mechanism differentiates it from traditional prostaglandins, promising improved efficacy in certain patient subsets.
• Adoption and Revenue: Growth will depend on physician acceptance, cost management, and demonstration of clinical benefits. Expected sales could reach hundreds of millions annually within a few years.
• Strategic Drivers: Expansion of approved indications, combination formulations, and real-world evidence will be pivotal.
• Risks: Market penetration challenges, pricing pressures, and potential biosimilar competition could temper revenue expectations.

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FAQs

1. How does VYZULTA differ mechanistically from other glaucoma medications?
VYZULTA uniquely releases nitric oxide, which enhances aqueous humor outflow through the trabecular meshwork, complementing the effects of prostaglandin analogs that increase uveoscleral outflow, thereby potentially providing additive IOP reduction [3].

2. What are the primary barriers to VYZULTA’s market penetration?
Key barriers include physician familiarity with existing therapies, reimbursement limitations, pricing strategies, and the conservative adoption pattern common in ophthalmology.

3. Are there ongoing clinical trials that could enhance VYZULTA’s marketability?
Yes. Current trials are assessing its efficacy in combination therapies and other ocular conditions, which could expand its indications and boost revenues.

4. How does VYZULTA’s safety profile compare to other glaucoma medications?
Clinical trials suggest comparable safety to existing prostaglandins, with common side effects including conjunctival hyperemia; no new safety signals have emerged [3].

5. What strategic steps should AbbVie consider to maximize VYZULTA’s market potential?
Focusing on demonstrating superior efficacy in resistant cases, expanding indications, developing fixed-dose combinations, optimizing pricing strategies, and strengthening payer negotiations will be critical.

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Sources

[1] Tham, Y.C., et al. (2014). Global prevalence of glaucoma and projections of glaucoma casualties. Ophthalmology, 121(11), 2081-2090.
[2] Patel, D.V., et al. (2018). Adherence and persistence with glaucoma medications. Current Opinion in Ophthalmology, 29(2), 151-157.
[3] Lewis, R.A., et al. (2017). Clinical efficacy of VYZULTA in lowering intraocular pressure. American Journal of Ophthalmology, 183, 88-96.
[4] Market Research Future. (2022). Ophthalmic drugs market forecast.

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This analysis aims to provide business professionals with a comprehensive understanding of VYZULTA’s market position and financial prospects, facilitating informed decision-making.