LATANOPROST - Generic Drug Details

What are the generic drug sources for latanoprost and what is the scope of freedom to operate?

Latanoprost is the generic ingredient in seven branded drugs marketed by Sun Pharm, Thea Pharma, Amring Pharms, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Micro Labs, Pharmobedient, Sandoz, Somerset, Upjohn, and Alcon Labs Inc, and is included in seventeen NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprost has fifty-three patent family members in thirty-one countries.

There are twenty drug master file entries for latanoprost. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LATANOPROST

International Patents:	53
US Patents:	24
Tradenames:	7
Applicants:	15
NDAs:	17
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	204
Drug Prices:	Drug price trends for LATANOPROST
Drug Sales Revenues:	Drug sales revenues for LATANOPROST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATANOPROST
What excipients (inactive ingredients) are in LATANOPROST?	LATANOPROST excipients list
DailyMed Link:	LATANOPROST at DailyMed

See drug prices for LATANOPROST

See drug sales revenues for LATANOPROST

Recent Clinical Trials for LATANOPROST

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

Sponsor	Phase
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,	PHASE4
Universitas Padjadjaran	PHASE2
PolyActiva Pty Ltd	PHASE2

See all LATANOPROST clinical trials

Generic filers with tentative approvals for LATANOPROST

Applicant	Application No.	Strength	Dosage Form
		0.005%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for LATANOPROST

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

US Patents and Regulatory Information for LATANOPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	091449-001	Mar 22, 2011	AT	RX	No	No
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	AT	RX	Yes	Yes
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes
Micro Labs	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	219306-001	Apr 14, 2025	AT	RX	No	No

Expired US Patents for LATANOPROST

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

International Patents for LATANOPROST

Country	Patent Number	Title	Estimated Expiration
Ukraine	100393	НОВЫЕ ОФТАЛЬМОЛОГИЧЕСКИЕ КОМПОЗИЦИИ;НОВІ ОФТАЛЬМОЛОГІЧНІ КОМПОЗИЦІЇ (NOVEL OPHTHALMIC COMPOITIONS)
Mexico	2010004211	COMPOSICION OFTALMICA QUE COMPRENDE UNA PROSTAGLANDINA. (OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN.)
Cyprus	1115396
Japan	5646331

Supplementary Protection Certificates for LATANOPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3461484	SPC/GB21/033	United Kingdom		PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107
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	2021C/515	Belgium		PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108
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 Latanoprost

Last updated: July 27, 2025

Introduction

Latanoprost, a prostaglandin F2α analog, is a cornerstone in glaucoma and ocular hypertension therapy. Approved by the FDA in 1996 under Xalatan, its compound has established a robust foothold globally. Its unique mechanism of increasing aqueous humor outflow, combined with favorable safety profile, has made it a first-line treatment in ophthalmology. The evolving landscape of this pharmaceutical hinges on market dynamics—competitive, regulatory, technological, and demographic factors—and the financial trajectory driven by escalating global demand and innovation.

Global Market Overview

The global latanoprost market was valued at approximately USD 1.28 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of around 6% from 2023 to 2030 [1]. The increasing prevalence of glaucoma, one of the leading causes of irreversible blindness worldwide, underscores an expanding patient base. According to the World Health Organization, over 76 million people suffer from glaucoma, projected to reach 111 million by 2040 [2].

The market is highly concentrated with a handful of key players, notably Pfizer (which markets Xalatan globally), Santen Pharmaceutical, and other regional manufacturers. Patent expirations and the advent of generic formulations have introduced price competition, influencing market dynamics.

Market Drivers

Epidemiological Growth

The rising aging population is a primary driver. Age-related ocular degeneration amplifies glaucoma risk, particularly over 60 years, who constitute about 60% of cases [3]. Urbanization and lifestyle factors augment intraocular pressure (IOP)—the primary therapeutic target—fueling demand for effective treatments like latanoprost.

Treatment Guidelines and Standard of Care

Clinical guidelines, including those from the American Academy of Ophthalmology (AAO), endorse prostaglandin analogs—including latanoprost—as first-line agents due to high efficacy and convenience. The ease of once-daily dosing increases patient adherence, promoting sustained market uptake.

Pipeline and Innovation

While latanoprost remains the benchmark, innovation in drug delivery (e.g., sustained-release implants) and combination therapies hint at future growth avenues. Generic versions, post-patent expiry, have further broadened market access, particularly in cost-sensitive regions.

Market Challenges

Patent Expiry and Generics

Pfizer's patent protection for Xalatan expired in 2018 in the US, leading to a surge in generic competition. Generics have reduced prices by up to 70%, pressuring brand revenues. In 2021, generic versions accounted for over 60% of US prescriptions for latanoprost [4].

Regulatory Hurdles

Stringent regulatory requirements, especially in emerging markets, can delay product approval and market expansion. Ensuring product quality and compliance constitutes a significant financial investment.

Regional Disparities

Developed markets exhibit high penetration rates, whereas emerging economies—despite high glaucoma prevalence—face barriers such as limited healthcare infrastructure, affordability, and regulatory complexities.

Financial Trajectory Analysis

Revenue Streams

Latanoprost's revenue is primarily driven by brand sales in mature markets such as the US, Europe, and Japan, with annual revenues exceeding USD 1 billion globally. The growth in emerging markets (e.g., China, India) is boosting overall sales figures.

Pricing Strategy

Pricing varies regionally: premium pricing prevails in developed markets, supported by branded formulations, whereas generics dominate low-income markets, emphasizing volume over margin. Strategic partnerships with local manufacturers facilitate market penetration.

Impact of Patent Expirations

The US patent expiry in 2018 precipitated a shift towards generics, causing immediate revenue decline for Pfizer but opening avenues for market expansion through lower-cost formulations. A similar pattern is observable in Europe and other jurisdictions.

Emerging Markets and Market Penetration

In regions like Asia-Pacific, increasing healthcare spending and regulatory liberalization drive market growth. Local manufacturing, coupled with affordability strategies, has accelerated penetration—potentially offsetting revenue declines from generic competition in developed markets.

Future Growth Projections

The global latanoprost market is anticipated to grow at a CAGR of approximately 6% over the next seven years, propelled by demographic shifts and increasing glaucoma awareness [1]. Strategic focus on biosimilars, novel delivery systems, and combination therapies could further redefine financial margins and market share.

Competitive Landscape and Product Differentiation

While Pfizer’s Xalatan remains dominant, several competitors are investing in developing alternatives. Santen’s Taflotan (also a prostaglandin analog) and emerging combination therapies aim to improve efficacy and reduce side effects. Biosimilar entries, following patent cliffs, are expected to increase market competition further, pressuring pricing and margins.

Regulatory and Reimbursement Environment

Reimbursement policies significantly influence market dynamics. High-cost branded latanoprost benefits from favorable coverage in developed systems, while cost-containment policies favor generics in emerging markets. Ongoing regulatory reviews aim to optimize access, but price regulation initiatives threaten revenue stability.

Innovations and Future Outlook

Emerging innovations include sustained-release drug delivery systems, reducing dosing frequency, and improving adherence. Gene therapy and novel pharmacological classes are in early stages but may eventually impact the market landscape.

Key Market Players and Strategic Initiatives

• Pfizer: Continues to explore new formulations and expansion into developing economies. Focused on maintaining licensing exclusivity and launching biosimilars post-patent expiration.
• Santen Pharmaceutical: Invests heavily in product pipeline expansion and strategic alliances in Asia-Pacific.
• Other players: Sun Pharma, Allergan (now part of AbbVie), and generic manufacturers are cornering specific segments with competitive pricing.

Key Takeaways

• The latanoprost market remains robust, driven by demographic expansion and clinical preference for prostaglandin analogs.
• Patent expiry has catalyzed generic proliferation, exerting downward pressure on prices but expanding access.
• Regional disparities influence market size and growth; emerging markets present significant untapped potential.
• Innovation in drug delivery and combination therapies are key to sustaining financial growth amid generic competition.
• Regulatory pathways and reimbursement schemes remain pivotal determinants of revenue stability and expansion.

FAQs

1. How has patent expiry affected latanoprost revenues globally?
Patent expiration in several key markets, notably the US in 2018, led to a surge in generic competitors, drastically reducing brand sales revenue but increasing access and volume sales in developing regions.

2. What developments could impact the future market size of latanoprost?
Innovations in sustained-release formulations, combination therapies, and the eventual introduction of biosimilars could reshape market dynamics, either by expanding the patient base or intensifying price competition.

3. Which regions offer the most growth opportunities for latanoprost?
Emerging markets in Asia-Pacific and Latin America present substantial growth potential due to rising glaucoma prevalence, increasing healthcare spending, and regulatory reforms.

4. What are the primary challenges faced by manufacturers of latanoprost?
Patent expiries, regulatory hurdles, pricing pressures, and competition from generics and biosimilars remain core challenges.

5. How does the integration of new technologies influence latanoprost’s financial outlook?
Advancements like sustained-release systems could improve patient adherence, potentially increasing market penetration and revenues, while also providing differentiated products amid competitive pressures.

---

References:

[1] Oncology, pharma & biopharma market research reports, 2022.
[2] WHO Global Data on Glaucoma, 2019.
[3] Tham YC, et al. "Global Prevalence of Glaucoma and Projections," Lancet Global Health, 2014.
[4] IQVIA, US Prescription Data, 2021.