LATANOPROST - Generic Drug Details

What are the generic drug sources for latanoprost and what is the scope of patent protection?

Latanoprost is the generic ingredient in six branded drugs marketed by Sun Pharm, Thea Pharma, Amring Pharms, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Ryan Labs, Sandoz, Somerset, Upjohn, and Alcon Labs Inc, and is included in fourteen 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LATANOPROST

International Patents:	53
US Patents:	24
Tradenames:	6
Applicants:	13
NDAs:	14
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	191
Patent Applications:	7,426
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
DataPharm Australia, CMAX Clinical Research, Agilex Australia	Phase 1
Aneira Pharma, Inc.	Phase 1
Peregrine Ophthalmic	Phase 1

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.

Pharmacology for LATANOPROST

Drug Class

Prostaglandin Analog

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
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Amring Pharms	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	200925-001	Mar 22, 2011	AT	RX	No	No
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	AT	RX	Yes	Yes

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
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996

International Patents for LATANOPROST

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	025026	СИСТЕМА ПОДАЧИ НЕВЯЗКОГО ПОЛИМЕРНОГО РАСТВОРА НА ОСНОВЕ ПРОСТАГЛАНДИНА, НЕ СОДЕРЖАЩЕГО КОНСЕРВАНТ (POLYMERIC DELIVERY SYSTEM FOR A NONVISCOUS PROSTAGLANDIN-BASED SOLUTION WITHOUT PRESERVATIVES)
South Africa	201002615	OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN
Denmark	2588078
Cyprus	1115396
Australia	2008344909

Supplementary Protection Certificates for LATANOPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	97C0111	Belgium		PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
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
0364417	C970039	Netherlands		PRODUCT NAME: [1R-[1 ALPHA (Z),2 BETA(R*),3 ALPHA,5ALPHA]]-7-[3,5-DIHYDROXY-2-(3-HYDROXY-5- FENYLPENTYL)CYCLOPENTYL]-5-HEPTEENZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN ESTER, IN HET BIJZONDER LATANOPROSTUM; NAT. REGISTRATION NO/DATE: RVG 21304 19970610; FIRST REGISTRATION: SE 12716 19960718
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
3461484	301101	Netherlands		PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108

LATANOPROST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Latanoprost

Introduction to Latanoprost

Latanoprost is a prostaglandin analogue used primarily to treat increased intraocular pressure associated with conditions such as glaucoma and ocular hypertension. It works by increasing the outflow of aqueous humor, thereby reducing intraocular pressure and preventing optic nerve damage and vision loss[3].

Global Market Size and Growth

The global latanoprost market was valued at USD 1.3 billion in 2023 and is projected to reach USD 1.6 billion by 2033, growing at a compound annual growth rate (CAGR) of 2.1% from 2024 to 2033. This growth is driven by the increasing prevalence of glaucoma and ocular hypertension, particularly among the aging population[3].

Regional Market Dynamics

North America

North America holds a significant share of the global latanoprost market, with a market size of USD 608.48 million in 2024. This region is expected to grow at a CAGR of 0.7% from 2024 to 2031. The brand drug segment dominates this market, benefiting from market exclusivity during the patent-protected period. However, the eventual expiration of patents will lead to the entry of generic alternatives, which may impact market dynamics[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for latanoprost, with a market size of USD 349.88 million in 2024 and a projected CAGR of 4.5% from 2024 to 2031. This growth is attributed to the large and diverse population, increasing prevalence of glaucoma and ocular hypertension, and improving access to healthcare services in countries like India and China[1][3].

Europe

Europe's latanoprost market was valued at a significant portion of the global revenue, although the exact figure for Europe is not specified in the sources. It is expected to grow at a CAGR of 1% from 2024 to 2031. The market here is driven by advanced healthcare infrastructure and a high prevalence of glaucoma and ocular hypertension[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa (MEA) also present growth opportunities, albeit at a slower pace. Latin America's market size was USD 76.06 million in 2024, with a CAGR of 1.9% from 2024 to 2031. The MEA region had a market size of USD 30.42 million in 2024, with a CAGR of 2.2% from 2024 to 2031. These regions require tailored marketing strategies and collaborations with local stakeholders to address unique cultural, economic, and regulatory landscapes[1].

Key Drivers of Market Growth

Increasing Prevalence of Glaucoma and Ocular Hypertension

The rise in the prevalence of glaucoma and ocular hypertension, especially among the aging population, is a significant driver of the latanoprost market. As the global population ages, the demand for effective treatments for these conditions increases[3].

Technological Advancements

Advancements in drug formulations, such as combination therapies and sustained-release formulations, enhance the effectiveness of latanoprost and improve patient compliance. These innovations are crucial for the market's growth[3].

Government Initiatives and Healthcare Infrastructure

Government initiatives aimed at improving access to healthcare and making medications more affordable contribute to the market's expansion. Expanding healthcare infrastructure, particularly in emerging markets, also boosts demand for latanoprost[3].

Financial Performance of Key Players

Santen Pharmaceutical Co., Ltd.

Santen Pharmaceutical, a major player in the ophthalmic drugs market, has shown strong financial performance. In Q1 FY2023, Santen reported a revenue growth of 9.0% (excluding FX impact), driven by a strong start across all regions, including a market recovery in China. The company's core operating profit improved significantly due to strong sales and cost optimization efforts[2].

Market Challenges

Patent Expiration and Generic Competition

The eventual expiration of patents for brand-name latanoprost products will lead to the entry of generic alternatives, which can significantly impact market dynamics and pricing. Pharmaceutical companies need to adapt to these changes by developing new formulations or expanding their product portfolios[1].

Regional Variations and Regulatory Landscapes

The latanoprost market is influenced by diverse regional needs and regulatory landscapes. Companies must adopt nuanced strategies that consider these variations to succeed in different markets[1].

Industry Trends

Combination Therapies and Sustained-Release Formulations

The development of combination therapies and sustained-release formulations is a key trend in the latanoprost market. These innovations improve therapeutic outcomes and patient compliance, contributing to market growth[3].

Growing Demand in Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, are experiencing a surge in demand for latanoprost due to better access to healthcare services and a growing burden of age-related eye diseases[3].

Key Takeaways

• The global latanoprost market is projected to grow from USD 1.3 billion in 2023 to USD 1.6 billion by 2033.
• North America and Asia Pacific are key regions driving market growth.
• Technological advancements and government initiatives are significant drivers of the market.
• Patent expiration and generic competition pose challenges for brand-name products.
• Emerging markets offer substantial growth opportunities due to improving healthcare infrastructure and increasing prevalence of glaucoma and ocular hypertension.

FAQs

What is the current global market size of latanoprost?

The global latanoprost market was valued at USD 1.3 billion in 2023[3].

What is the projected growth rate of the latanoprost market from 2024 to 2033?

The latanoprost market is expected to grow at a CAGR of 2.1% from 2024 to 2033[3].

Which region is the fastest-growing market for latanoprost?

The Asia Pacific region is the fastest-growing market for latanoprost, with a projected CAGR of 4.5% from 2024 to 2031[1].

What are the main drivers of the latanoprost market?

The main drivers include the increasing prevalence of glaucoma and ocular hypertension, technological advancements in drug formulations, and government initiatives to improve healthcare access[3].

How does patent expiration impact the latanoprost market?

Patent expiration leads to the entry of generic alternatives, which can impact market dynamics and pricing for brand-name products[1].

Sources

1. Cognitive Market Research: Latanoprost Market Report.
2. Santen Pharmaceutical: Q1 FY2023 Financial Results.
3. Allied Market Research: Latanoprost Market Size, Report | Industry Analysis, 2033.