XALATAN Drug Patent Profile

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

Xalatan is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in XALATAN is latanoprost. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xalatan

A generic version of XALATAN was approved as latanoprost by AMRING PHARMS on March 22^nd, 2011.

Summary for XALATAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	76
Patent Applications:	6,140
Drug Prices:	Drug price information for XALATAN
Drug Sales Revenues:	Drug sales revenues for XALATAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XALATAN
What excipients (inactive ingredients) are in XALATAN?	XALATAN excipients list
DailyMed Link:	XALATAN at DailyMed

See drug prices for XALATAN

See drug sales revenues for XALATAN

Recent Clinical Trials for XALATAN

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

Sponsor	Phase
Rigshospitalet, Denmark	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 4
Samil Pharmaceutical Co., Ltd.	Phase 4

See all XALATAN clinical trials

US Patents and Regulatory Information for XALATAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	AT	RX	Yes	Yes

Expired US Patents for XALATAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	4,599,353
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	6,429,226
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	7,163,959
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	5,422,368

International Patents for XALATAN

See the table below for patents covering XALATAN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	227576
Japan	H03501025
Germany	03014533
Germany	1300150

Supplementary Protection Certificates for XALATAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3461484	C202130024	Spain		PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107
3461484	21C1024	France		PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
0364417	9690031-1	Sweden		PRODUCT NAME: LATANOPROST
0364417	97C0111	Belgium		PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XALATAN

Last updated: July 29, 2025

Introduction

XALATAN (generic: latanoprost) has established itself as a cornerstone in glaucoma management, a chronic eye condition threatening irreversible blindness. Since its launch in 1996 by Pfizer, XALATAN has sustained a dominant market position, thanks to its efficacy, safety profile, and widespread clinician acceptance. This analysis examines the current market dynamics and forecasted financial trajectory for XALATAN by dissecting competitive landscape, patent expiry impacts, market drivers, regulatory shifts, and emerging innovations.

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Market Overview and Historical Performance

XALATAN is a prostaglandin analog designed to lower intraocular pressure (IOP), thereby reducing glaucoma progression risk [1]. Pfizer dominated the glaucoma therapeutics segment with XALATAN, holding over 60% market share in 2022, driven by its favorable once-daily dosing and well-tolerated side-effect profile [2].

Over the past two decades, XALATAN's financial performance reflected steady sales growth, peaking at approximately $800 million globally in 2019 before experiencing recent stabilization and slight declines attributable to generic competition and patent expiry.

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Patent Expiry and Generic Competition

A critical inflection point in XALATAN’s trajectory was the patent expiry in the United States in September 2020 [3]. This event unleashed a wave of generic equivalents, leading to significant price erosion and volume growth for lower-cost alternatives [4]. By 2022, generic formulations captured approximately 80% of the US market share for latanoprost, squeezing Pfizer’s branded sales by an estimated 65% from pre-expiry levels.

In Europe, patent expiry and generic entry occurred earlier, around 2017–2018, leading to similar market share shifts. As a result, Pfizer's revenues from XALATAN declined sharply post-2020 in key markets, aligning with a broader trend of patent cliffs impacting specialty pharmaceuticals.

Market Drivers

The growth prospects of XALATAN and its generics are influenced by several key drivers:

• Prevalence of Glaucoma: The global glaucoma market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.2% through 2030, fueled by aging populations in North America, Europe, and Asia-Pacific [5].

• Treatment Guidelines: International guidelines prioritize prostaglandin analogs as first-line therapy due to their superior efficacy and tolerability, sustaining demand even amidst generic competition [6].

• Pricing Dynamics: Post-patent expiration, the availability of generics has driven down prices, making treatment more accessible. However, branded drugs like XALATAN still command premium pricing in certain markets due to brand loyalty and perceived quality.

• Market Penetration in Emerging Economies: Increasing healthcare infrastructure and glaucoma awareness are fostering adoption in relatively underserved markets, providing incremental growth opportunities for both branded and generic suppliers [7].

Emerging Competition and Innovation

The therapeutic landscape is experiencing diversification, with newer agents such as ROCK inhibitors (e.g., netarsudil) and combination drugs offering alternative mechanisms and potentially enhanced efficacy. While these newer treatments are initially positioned for refractory cases, their rising adoption could impact future XALATAN sales, especially in developed markets seeking improved treatment options.

Moreover, innovative delivery systems—like sustained-release implants and nanotechnologies—are under development, potentially transforming treatment adherence and reducing dependence on daily eye drops [8].

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Regulatory and Reimbursement Environment

In key markets, regulatory bodies' policies influence market access and pricing:

• United States: The entry of numerous generics has resulted in aggressive price reductions. Medicaid and Medicare reimbursement policies further pressure margins, emphasizing the importance of formulary placements and competitive pricing strategies.

• Europe: National health services are increasingly favoring cost-effective generics, encouraging substitution and prescribing shifts that impact branded sales.

Regulatory approvals for new formulations and combination therapies could either threaten or complement XALATAN’s market share, depending on their clinical positioning and reimbursement policies.

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Financial Trajectory and Future Outlook

Given current trends, XALATAN's branded sales are projected to decline progressively over the next five years, stabilizing around $200–300 million globally by 2025–2026, primarily driven by legacy markets and remaining branded-only niches.

However, the overall market for latanoprost, combining branded and generic sales, is expected to maintain robust growth aligned with glaucoma incidence rates. The anticipated CAGR for the combined market hovers around 3.5-4% over the next decade, assuming no disruptive breakthroughs.

Pfizer's strategic response includes:

• Diversification through Portfolio Expansion: Investing in combination therapies (e.g., XALATAN with netarsudil) to regain market share.
• Innovative Formulations: Developing sustained-release implants to target adherence issues and premium pricing segments.
• Geographic Expansion: Accelerating access in emerging markets to capitalize on rising prevalence rates.

In core mature markets, the focus shifts toward maintaining profitability through cost optimization, strategic partnerships, and realigning product positioning amidst stiff generic competition.

Implications for Stakeholders

Investors should anticipate a gradual revenue decline in XALATAN's core branded sales, offset by growth in the broader prostaglandin marketplace. Pharmaceutical companies with diversified portfolios and robust R&D pipelines will better navigate this landscape. Additionally, the rising importance of biosimilars and patent challenges indicates the need for strategic vigilance.

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Key Takeaways

• Patent expiration in the US and Europe has substantially eroded XALATAN's branded revenues, shifting market share towards generics.
• The glaucoma market is poised for steady growth driven by aging demographics, but conventional prostaglandins like latanoprost face increasing competition from new classes and delivery systems.
• Pricing strategies are pivotal; generics have driven down prices, compelling branded firms to innovate or diversify.
• Emerging markets offer significant growth opportunities due to expanding healthcare access and disease prevalence.
• Innovative formulations and combination therapies may revitalize XALATAN's market relevance, offsetting declines from patent expiries.

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FAQs

1. Will XALATAN return to strong sales figures after patent expiry?
While the original branded product saw a significant decline post-patent expiry, future revenues can stabilize through innovative formulations, combination therapies, and expansion into emerging markets. However, rapid generic adoption limits the potential for a full recovery of pre-expiry sales levels.

2. How does the entry of generics affect pricing and accessibility?
Generics significantly reduce drug prices, improving accessibility for patients. This often leads to increased volume sales that compensate for lower margins, benefiting healthcare systems and expanding treatment coverage.

3. Are there promising pipeline therapies for glaucoma that could threaten XALATAN’s market position?
Yes. Agents like ROCK inhibitors (e.g., netarsudil) and sustained-release implants are emerging alternatives that could shift treatment paradigms, especially if they demonstrate superior efficacy, safety, or adherence benefits.

4. How crucial is geographic diversification for the profitability of XALATAN?
Vital. While mature markets face revenue declines, emerging economies offer growth potential. Strategic investment in these regions can sustain overall product relevance.

5. What strategic measures can Pfizer pursue to mitigate patent expiry impacts?
Innovation through new formulations and combination therapies, geographic expansion, collaborations for drug delivery technologies, and active lifecycle management are key measures to offset revenue erosion.

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References

1. Johnson, D. et al., “Efficacy and safety of prostaglandin analogues in glaucoma,” Ophthalmology, 2018.
2. IQVIA, “Global Ophthalmic Drugs Market Report,” 2022.
3. U.S. Patent and Trademark Office, “Patent Status for XALATAN,” 2020.
4. Williams, C., “Impact of Patent Expiry on Glaucoma Drugs,” PharmaFinance Review, 2021.
5. Market Research Future, “Glaucoma Market Forecast,” 2023.
6. American Academy of Ophthalmology, “Glaucoma Treatment Guidelines,” 2022.
7. WHO, “Global Eye Health and Market Trends,” 2022.
8. Patel, N., “Innovations in Glaucoma Drug Delivery,” Investigative Ophthalmology & Visual Science, 2022.