VYZULTA Drug Patent Profile

Which patents cover Vyzulta, and what generic alternatives are available?

Vyzulta is a drug marketed by Bausch And Lomb and is included in one NDA. There is one patent 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:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYZULTA

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 one 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	8,058,467			Y

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
Hong Kong	1096084	PROSTAGLANDIN NITROOXYDERIVATIVES
Israel	132690	PROSTAGLANDIN PHARMACEUTICAL COMPOSITIONS
Georgia, Republic of	P20094780	PROSTAGLANDIN NITROOXYDERIVATIVES
Japan	2002506440

Investment Scenario and Fundamentals Analysis for VYZULTA

Last updated: February 19, 2026

What is VYZULTA?

VYZULTA (latanoprost bunod ophthalmic solution) is a glaucoma medication developed by Bausch + Lomb. It received FDA approval in December 2017 for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The drug operates via a dual mechanism: increasing uveoscleral outflow and promoting aqueous humor outflow by releasing nitric oxide.

Market Overview and Commercial Potential

Market Size and Dynamics

• Global Glaucoma Market: Valued at approximately USD 4.27 billion in 2022, with a projected CAGR of 3.9% through 2030 (Grand View Research, 2022).
• Addressable Market: About 80 million worldwide with open-angle glaucoma, representing vast scope for VYZULTA's penetration.
• Competitive Landscape: Dominated by prostaglandin analogs like latanoprost, bimatoprost, and travoprost. VYZULTA's unique MOA may provide differentiation, especially in patients unresponsive to existing therapies.

Revenue Potential

• Pricing: VYZULTA is priced comparable to other ophthalmic glaucoma drugs, roughly USD 150–200 per month per patient.
• Market Penetration: Will depend on formulary acceptance and physician adoption. Competitors have established market shares; VYZULTA's dual MOA could appeal to a subset of patients with inadequate response.

Sales Projections

• Initial Launch (2018-2021): Modest, USD 20–30 million annually, constrained by limited formulary placement.
• Mid-term (2022–2025): Expected growth to USD 100 million, driven by increased prescriber acceptance and expanded formulary positioning.
• Long-term (2026 and beyond): Potential to surpass USD 200 million if the drug secures broad adoption and displays superior efficacy or safety.

Commercialization and Regulatory Factors

• FDA Approval: The approval process finalized in 2017. No major post-approval regulatory challenges reported.
• Labeling and Indications: Clear indication for open-angle glaucoma and ocular hypertension.
• Patent Protection: Patents extend until at least 2030, providing exclusivity.

Competitive Positioning and Differentiators

• Mechanism of Action: Combines prostaglandin analog effects with nitric oxide-mediated outflow enhancement, potentially enhancing efficacy in refractory cases.
• Safety Profile: Demonstrates tolerability similar to other prostaglandins. No significant safety signals reported.
• Patient Compliance: Once-daily dosing improves adherence compared to multiple-dose regimens.

Risk Factors

• Competitive Risks: Established prostaglandin analogs have high physician familiarity.
• Regulatory Risks: Minimal, but any new safety concerns could impact sales.
• Market Dynamics: Price erosion and formulary battles could limit revenue growth.
• Pipeline Competition: Emerging drugs targeting same pathway or MOA, such as unoprostone and nitric oxide donors.

Investment Outlook

Positives

• Favorable regulatory status and patent protection.
• Innovative dual-mechanism suggests potential for differentiated efficacy.
• Growing glaucoma prevalence supports expanding patient base.

Concerns

• Market saturation by existing treatments.
• Reliance on formulary and physician adoption.
• Access and reimbursement challenges in certain markets.

Key Takeaways

VYZULTA holds a niche in the glaucoma treatment landscape, with a differentiated MOA and a favorable safety profile. Market penetration depends heavily on formulary acceptance, physician education, and competitive positioning. Long-term revenue prospects are promising if the drug can demonstrate superior efficacy or address unmet patient needs. Risks include intense competition and market access hurdles.

FAQs

Q1: What makes VYZULTA different from other glaucoma medications?
A: Its dual mechanism combines prostaglandin analog effects with nitric oxide-mediated outflow, potentially offering increased efficacy for some patient populations.

Q2: How is VYZULTA priced compared to other glaucoma drugs?
A: It costs approximately USD 150–200 per month, comparable to other prostaglandin analogs.

Q3: What are the main barriers to market growth?
A: Established competitors' market share, formulary restrictions, and physician prescribing habits.

Q4: What is the patent status for VYZULTA?
A: Patents extend through at least 2030, providing market exclusivity during this period.

Q5: How significant is the glaucoma market globally?
A: It is valued at around USD 4.27 billion in 2022, with a growing patient base nationwide and worldwide.

References

1. Grand View Research. (2022). Glaucoma therapeutics market size, share & trends.
2. U.S. Food and Drug Administration. (2017). VYZULTA approval letter.