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. Fourteen 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:	3
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	76
Patent Applications:	6,226
Drug Prices:	Drug price information 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
CHA University	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
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996

International Patents for XALATAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1300149
European Patent Office	1225168	Dérivé de prostaglandine-F-2-alpha pour le traitement du glaucome et de l'hypertension oculaire (Prostaglandin-F-2 alpha derivative for the treatment of glaucoma or ocular hypertension)
European Patent Office	1224934
Germany	03014533
Japan	H08109132	COMPOSITION FOR OPHTHALMOLOGY FOR LOCAL MEDICAL TREATMENT OFGLAUCOMA OR STENIA OF INTRAOCULAR TENSION CONTAINING PROSTAGLANDIN DERIVATIVE
Spain	2317964

Supplementary Protection Certificates for XALATAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3461484	132021000000068	Italy		PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3461484	2021C/515	Belgium		PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108
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
3461484	301101	Netherlands		PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108
0364417	97C0111	Belgium		PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
0364417	SPC/GB97/014	United Kingdom		PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216

Market Dynamics and Financial Trajectory for XALATAN (Latanoprost)

Introduction to XALATAN (Latanoprost)

XALATAN, also known as latanoprost, is a prostaglandin analogue used primarily as an anti-hypertensive and anti-glaucoma agent. It is widely prescribed to manage intraocular pressure in patients with glaucoma or ocular hypertension.

Global Market Size and Growth

The global latanoprost market was valued at USD 1.43 billion in 2023 and is projected to reach USD 1.74 billion by 2032, growing at a compound annual growth rate (CAGR) of 2.2% during this period[4].

Regional Market Breakdown

North America

North America is the largest market for latanoprost, accounting for more than 40% of the global revenue. In 2024, the North American market size was estimated at USD 608.48 million and is expected to grow at a CAGR of 0.7% from 2024 to 2031. The brand drug segment dominates this market, although the eventual expiration of patents will lead to increased competition from generic alternatives[1].

Europe

The European market for latanoprost is significant, with a market size of USD 1521.2 million in 2024, although this figure seems to be a global estimate rather than a regional one. The European market is expected to grow at a CAGR of 1% from 2024 to 2031. The region's advanced healthcare infrastructure and high prevalence of glaucoma and ocular hypertension drive this growth[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global latanoprost market, with a market size of USD 349.88 million in 2024. This region is expected to grow at a CAGR of 4.5% from 2024 to 2031, driven by a large and diverse population and an increasing prevalence of glaucoma and ocular hypertension[1].

Middle East and Africa

The Middle East and Africa (MEA) region accounts for around 2% of the global latanoprost market, with a market size of USD 30.42 million in 2024. The MEA market is expected to grow at a CAGR of 2.2% from 2024 to 2031. Success in this region requires a tailored approach considering the diverse cultural, economic, and regulatory landscapes[1].

Key Drivers of the Market

Aging Population

The global aging population is a significant driver of the latanoprost market. As people age, the prevalence of glaucoma and ocular hypertension increases, leading to higher demand for medications like latanoprost[1].

Advanced Healthcare Infrastructure

Regions with advanced healthcare infrastructure, such as North America and Europe, contribute substantially to the market growth due to better diagnostic capabilities and treatment options for glaucoma and ocular hypertension[1].

Technological Advancements

The incorporation of technologies like optical coherence tomography (OCT) in hospitals enhances the diagnosis and management of glaucoma, thereby increasing the demand for latanoprost[4].

Financial Performance of Key Players

Santen Pharmaceutical

Santen Pharmaceutical, a major player in the ophthalmic drug market, has shown strong financial performance. In Q1 FY2023, Santen reported a revenue increase of 10.5% YoY, driven by strong sales across regions, including a significant recovery in the Chinese market. The company also achieved a gross margin increase of 14.3% YoY and a core operating profit increase of 46.6% YoY, largely due to cost optimization and structural reforms[5].

Other Key Players

Other key players in the latanoprost market include Pfizer, Mylan, Novartis, Apotex, and Teva. These companies have a significant presence in the global market and contribute to its growth through their extensive product portfolios and distribution networks[4].

Market Challenges

Patent Expiration

The expiration of patents for brand-name latanoprost products leads to the entry of generic alternatives, which can significantly impact the market dynamics. Generic drugs often offer lower prices, reducing the market share and revenue of brand-name drugs[1].

Regulatory Landscape

The regulatory environment in different regions can pose challenges. Companies must adapt to diverse cultural, economic, and regulatory landscapes, especially in regions like the Middle East and Africa[1].

Competitive Landscape

The latanoprost market is competitive, with several key players vying for market share. The brand drug segment initially enjoys market exclusivity, but the eventual entry of generic alternatives increases competition. Companies must focus on cost optimization, structural reforms, and strategic marketing to maintain their market position[1][4].

Future Outlook

The global latanoprost market is expected to continue growing, driven by the increasing prevalence of glaucoma and ocular hypertension, advancements in healthcare infrastructure, and the aging population. However, companies must navigate the challenges of patent expirations and regulatory complexities to maintain their market presence.

Key Takeaways

• The global latanoprost market is projected to grow from USD 1.43 billion in 2023 to USD 1.74 billion by 2032.
• North America is the largest market, followed by Europe and the Asia Pacific.
• The market is driven by an aging population, advanced healthcare infrastructure, and technological advancements.
• Key players include Santen Pharmaceutical, Pfizer, Mylan, Novartis, Apotex, and Teva.
• Patent expirations and regulatory complexities are significant challenges.

Frequently Asked Questions

What is the expected global market size of latanoprost by 2032?

The global latanoprost market is expected to reach USD 1.74 billion by 2032[4].

What is the CAGR of the latanoprost market from 2023 to 2032?

The latanoprost market is expected to exhibit a CAGR of 2.2% from 2023 to 2032[4].

Which regions are the largest markets for latanoprost?

North America, Europe, and the Asia Pacific are the largest markets for latanoprost[1].

What are the key drivers of the latanoprost market?

The key drivers include an aging population, advanced healthcare infrastructure, and technological advancements such as optical coherence tomography[1][4].

Who are the major players in the latanoprost market?

Major players include Pfizer, Mylan, Novartis, Apotex, Teva, and Santen Pharmaceutical[4].

Sources

1. Cognitive Market Research: Latanoprost Market Report.
2. Santen Pharmaceutical: Q2 FY2023 Financial Results.
3. Proxy Statement for 2013 Annual Meeting of Shareholders: Pfizer.
4. Business Research Insights: Latanoprost Market Size, Share, Growth, Trends, Forecast, 2032.
5. Santen Pharmaceutical: Q1 FY2023 Financial Results.