IYUZEH Drug Patent Profile

When do Iyuzeh patents expire, and what generic alternatives are available?

Iyuzeh is a drug marketed by Thea Pharma and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-four patent family members in twenty-seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iyuzeh

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

Summary for IYUZEH

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	6,226
Drug Prices:	Drug price information for IYUZEH
What excipients (inactive ingredients) are in IYUZEH?	IYUZEH excipients list
DailyMed Link:	IYUZEH at DailyMed

See drug prices for IYUZEH

US Patents and Regulatory Information for IYUZEH

IYUZEH 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
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472-001	Dec 13, 2022		RX	Yes	Yes	8,637,054		Y

International Patents for IYUZEH

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

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)
Denmark	2588078
Cyprus	1115396
Japan	2015038099	防腐剤を含まない非粘性プロスタグランジン系点眼液用のポリマー送達システム (POLYMER DELIVERY SYSTEM FOR NON-VISCOUS PROSTAGLANDIN-BASED OPHTHALMIC SOLUTION CONTAINING NO ANTISEPTIC)
Morocco	34324	SYSTEME DE DELIVRANCE POLYMERIQUE D'UNE SOLUTION NON VISQUEUSE A BASE DE PROSTAGLANDINE SANS CONSERVATEUR

Supplementary Protection Certificates for IYUZEH

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

IYUZEH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IYUZEH (Latanoprost Ophthalmic Solution)

Introduction to IYUZEH

IYUZEH, a preservative-free latanoprost ophthalmic solution, has recently been launched in the U.S. market by Thea Pharma Inc., a subsidiary of Europe’s leading independent ophthalmic-focused pharmaceutical company, Théa. This product is specifically designed for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT)[2][5].

Global Market Context for Ophthalmic Drugs

The ophthalmic drugs market is experiencing significant growth, driven by factors such as an increase in eye disorders, advancements in research and development, and a rising global elderly population. The market is projected to grow from $36.77 billion in 2023 to $39.82 billion in 2024, and further to $53.09 billion by 2028, at a compound annual growth rate (CAGR) of 7.5%[3].

Market Size and Growth of Latanoprost

The global Latanoprost market was estimated at USD 1521.2 million in 2024 and is expected to expand at a CAGR of 2.50% from 2024 to 2031. This growth is fueled by the increasing prevalence of glaucoma and ocular hypertension, particularly among the aging population[1].

Regional Market Dynamics

North America

North America holds a significant share of the global Latanoprost market, with over 40% of the global revenue, amounting to USD 608.48 million in 2024. The market in this region 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 the entry of generic alternatives[1].

Europe

Europe accounts for over 30% of the global Latanoprost market, with a market value of USD 456.36 million in 2024. The region's well-established healthcare systems and stringent regulatory frameworks contribute to its market size. Europe's Latanoprost market is projected to grow at a CAGR of 1.0% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, 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 revenue, 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, requiring a tailored approach due to diverse cultural, economic, and regulatory landscapes[1].

Unique Selling Points of IYUZEH

Preservative-Free Formulation

IYUZEH is the first and only preservative-free latanoprost ophthalmic solution available in the U.S. market. This formulation addresses an important unmet need by providing a treatment option without preservatives, which can be beneficial for patients sensitive to preservatives[2][5].

Efficacy and Clinical Trials

In randomized, controlled clinical trials, IYUZEH has demonstrated efficacy similar to traditional latanoprost, lowering intraocular pressure (IOP) by 3–8 mmHg in patients with POAG or OHT. This efficacy is comparable to other established treatments like Xalatan[5].

Market Opportunities and Challenges

Market Opportunities

• Growing Demand: The increasing prevalence of glaucoma and ocular hypertension, especially among the aging population, presents a significant market opportunity for IYUZEH.
• Expanding Healthcare Infrastructure: Advances in healthcare infrastructure, particularly in regions like North America and Europe, facilitate early diagnosis and treatment, which can drive demand for IYUZEH.
• Global Reach: With IYUZEH already available in 46 countries under the brand name Monoprost, the U.S. launch expands its global footprint, potentially increasing its market share[2][5].

Market Challenges

• Regulatory Scrutiny: Generic versions of latanoprost undergo rigorous regulatory scrutiny to ensure bioequivalence, safety, and efficacy, which can present challenges for market entry and expansion[1].
• Patent Expiration: The eventual expiration of patents for brand-name latanoprost drugs will lead to increased competition from generic alternatives, potentially affecting the market share of IYUZEH[1].
• Diverse Market Landscapes: In regions like the MEA, a tailored approach is necessary due to diverse cultural, economic, and regulatory landscapes, which can complicate market penetration[1].

Financial Trajectory

Current Market Value

The launch of IYUZEH in the U.S. market is expected to contribute to the overall growth of the Latanoprost market, which was valued at USD 1521.2 million in 2024[1].

Growth Projections

Given the CAGR of 2.50% for the global Latanoprost market from 2024 to 2031, and the specific growth rates in different regions, IYUZEH is poised to capture a significant share of this growing market. The preservative-free formulation and proven efficacy are likely to attract a substantial patient base, contributing to the financial growth of Thea Pharma Inc.[1].

Revenue Potential

With about 1.5 million patients treated monthly with Monoprost (the brand name for IYUZEH in other countries), the U.S. launch is expected to add significantly to this number. The revenue potential is substantial, especially considering the high prevalence of glaucoma and ocular hypertension in the U.S. and the lack of preservative-free alternatives in the market[2][5].

Key Takeaways

• Growing Market: The ophthalmic drugs market, including the Latanoprost segment, is experiencing significant growth driven by demographic trends and healthcare advancements.
• Unique Selling Points: IYUZEH's preservative-free formulation and proven efficacy make it a valuable treatment option for patients with POAG and OHT.
• Regional Opportunities: The product has substantial market opportunities in North America, Europe, Asia Pacific, and the MEA region, each with its unique challenges and growth potential.
• Financial Growth: The launch of IYUZEH in the U.S. is expected to contribute to the financial growth of Thea Pharma Inc., leveraging the growing demand for ophthalmic treatments.

FAQs

What is IYUZEH, and how is it different from other latanoprost products?

IYUZEH is a preservative-free latanoprost ophthalmic solution, making it unique in the U.S. market where it is the first and only preservative-free option for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT)[2][5].

How does IYUZEH perform in clinical trials?

In clinical trials, IYUZEH has demonstrated efficacy similar to traditional latanoprost, lowering intraocular pressure (IOP) by 3–8 mmHg in patients with POAG or OHT[5].

What are the key drivers of the ophthalmic drugs market?

The key drivers include a rise in the incidence of eye disorders, significant investments in research and development, shifts in lifestyles impacting eye health, and various government initiatives aimed at promoting and enhancing vision care[3].

How is the global Latanoprost market expected to grow?

The global Latanoprost market is expected to grow at a CAGR of 2.50% from 2024 to 2031, driven by factors such as an aging population and advanced healthcare infrastructure[1].

What are the main challenges for IYUZEH in the market?

The main challenges include regulatory scrutiny for generic versions, the eventual expiration of patents leading to increased competition, and the need for a tailored approach in diverse market landscapes like the MEA region[1].

Sources

1. Cognitive Market Research: Latanoprost Market Report.
2. Thea Pharma Inc.: Thea Pharma Inc. Launches IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S.
3. Research and Markets: Ophthalmic Drugs Global Market Report 2024.
4. Fortune Business Insights: Ophthalmic Disease Therapeutics Market Size | Growth [2032].
5. Ophthalmology Times: Thea Pharma rolls out latanoprost ophthalmic solution 0.005% in the U.S.