TAFLUPROST - Generic Drug Details

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

Tafluprost is the generic ingredient in two branded drugs marketed by Ingenus Pharms Llc, Micro Labs, Sandoz, and Thea Pharma, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tafluprost has eighty-one patent family members in twenty-six countries.

There are three drug master file entries for tafluprost. Five suppliers are listed for this compound.

Summary for TAFLUPROST

International Patents:	81
US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	29
Patent Applications:	927
Drug Prices:	Drug price trends for TAFLUPROST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAFLUPROST
What excipients (inactive ingredients) are in TAFLUPROST?	TAFLUPROST excipients list
DailyMed Link:	TAFLUPROST at DailyMed

See drug prices for TAFLUPROST

Recent Clinical Trials for TAFLUPROST

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

Sponsor	Phase
Fondazione G.B. Bietti, IRCCS	Phase 4
Tun Hussein Onn National Eye Hospital	Phase 4
Taejoon Pharmaceutical Co., Ltd.	Phase 4

See all TAFLUPROST clinical trials

Pharmacology for TAFLUPROST

Drug Class	Prostaglandin Analog
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Increased Prostaglandin Activity

Anatomical Therapeutic Chemical (ATC) Classes for TAFLUPROST

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

Paragraph IV (Patent) Challenges for TAFLUPROST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIOPTAN	Ophthalmic Solution	tafluprost	0.0015%	202514	2	2016-02-10

US Patents and Regulatory Information for TAFLUPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes			Y
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes			Y
Ingenus Pharms Llc	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	218002-001	Apr 5, 2024		DISCN	No	No
Sandoz	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	209040-001	Jan 28, 2022	AT	RX	No	No

Expired US Patents for TAFLUPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012

International Patents for TAFLUPROST

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120351
Taiwan	201000104	Method and composition for treating ocular hypertension and glaucoma
South Korea	20190067272	고안압증과 녹내장의 치료 방법 및 조성물 (METHOD AND COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA)
South Korea	101988642

Supplementary Protection Certificates for TAFLUPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0850926	SPC/GB09/005	United Kingdom		PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017
0850926	C00850926/01	Switzerland		PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
0850926	11C0020	France		PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430

TAFLUPROST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tafluprost Eye Drops

Introduction

Tafluprost, a prostaglandin analog, is a key medication in the treatment of glaucoma and ocular hypertension. The market for Tafluprost eye drops is influenced by several factors, including demographic changes, healthcare trends, and pharmaceutical industry dynamics. Here, we delve into the market dynamics and financial trajectory of Tafluprost eye drops.

Market Drivers

Rising Prevalence of Glaucoma and Ocular Hypertension

The increasing prevalence of glaucoma and ocular hypertension, particularly among aging populations, is a significant driver for the Tafluprost eye drops market. As the global population ages, the demand for effective treatments for these conditions is expected to rise[1].

Growing Healthcare Expenditure

Increased healthcare expenditure in various regions, especially in Asia and EMEA, is another factor contributing to the growth of the Tafluprost market. Countries with robust healthcare systems and reimbursement policies support the adoption of these eye drops[3].

Regional Market Performance

Asia

The Asian market has shown solid growth trends driven by glaucoma and dry eye products. Countries like Korea, Vietnam, Thailand, Taiwan, and the Philippines have experienced double-digit growth, partly due to the strong performance of core products like Tafluprost[3].

EMEA

In the EMEA region, Tafluprost and other glaucoma-related products have driven significant revenue growth. Key countries such as Italy, Germany, and the UK have contributed substantially to this growth, with products like Cosopt, Tapcom, and Tapros showing strong sales[3].

Americas

Despite flat revenue due to foreign exchange impacts, the Americas region has seen increased revenue from glaucoma and dry eye products. However, profitability remains a challenge in this region[3].

Japan

In Japan, Tafluprost has been part of the mainstay products that have performed better than expected, particularly in the fourth quarter of FY2022. This performance has helped absorb the impact of market contractions in other regions[5].

Financial Performance of Key Players

Santen Pharmaceutical

Santen Pharmaceutical, a major player in the ophthalmic drug market, has reported significant financial performance related to Tafluprost and other ophthalmic products.

• Revenue Growth: Santen achieved its highest revenue in FY2023, with JPY 302.0 billion, a 8.2% increase year-over-year (YoY)[2].
• Core Operating Profit: The core operating profit increased by 41.9% YoY to JPY 62.8 billion, driven by cost optimization and structural reforms[2].
• Regional Contribution: The company saw increased contribution profits from overseas regions, including China, Asia, and EMEA, while Japan's contribution was impacted by decreased revenue and increased COGS ratio[2].

Market Size and Growth Projections

Global Market Size

The global market for Tafluprost eye drops is expected to grow significantly over the next few years. The market size is projected to increase from its current value to a substantial figure by 2030, driven by the rising prevalence of glaucoma and ocular hypertension[1][4].

CAGR and Growth Rate

The market is anticipated to grow at a compound annual growth rate (CAGR) of a certain percentage from 2024 to 2030. This growth rate is influenced by factors such as demographic changes, market penetration of core products, and healthcare expenditure[4].

Competitive Landscape

Product Portfolio

Companies like Santen Pharmaceutical have a robust product portfolio that includes Tafluprost along with other ophthalmic medications. The performance of these products is crucial in maintaining market share and driving growth[2].

Market Penetration

The market penetration of core products, including Tafluprost, has been a key strategy for companies. This involves expanding into new markets and increasing the adoption of these products in existing markets[3].

Regulatory and Reimbursement Environment

National Reimbursement Drug List (NRDL)

In some regions, products like Verkazia being listed on the NRDL has positively impacted the market. Such listings enhance the accessibility and affordability of these medications, contributing to market growth[3].

Challenges and Opportunities

Profitability and Cost Optimization

Despite strong revenue growth, profitability remains a challenge, particularly in regions like the Americas. Companies are focusing on cost optimization and structural reforms to improve profitability[2].

Research and Development

Investments in research and development are crucial for the long-term growth of the Tafluprost market. Companies are making progress in areas such as myopia and ptosis, which could open up new opportunities[2].

Key Takeaways

• The Tafluprost eye drops market is driven by the rising prevalence of glaucoma and ocular hypertension.
• Regional performance varies, with Asia and EMEA showing strong growth, while the Americas face profitability challenges.
• Santen Pharmaceutical has reported significant financial growth driven by core products like Tafluprost.
• The global market is projected to grow at a substantial CAGR from 2024 to 2030.
• Market penetration and regulatory environments play critical roles in the market's growth.

FAQs

What are the primary drivers of the Tafluprost eye drops market?

The primary drivers include the rising prevalence of glaucoma and ocular hypertension, particularly among aging populations, and increasing healthcare expenditure in various regions.

How has Santen Pharmaceutical performed financially in relation to Tafluprost?

Santen Pharmaceutical achieved its highest revenue in FY2023, with a significant increase in core operating profit driven by cost optimization and structural reforms.

What are the growth projections for the global Tafluprost eye drops market?

The market is expected to grow at a substantial CAGR from 2024 to 2030, driven by demographic changes and healthcare trends.

Which regions have shown the strongest growth for Tafluprost?

Asia and EMEA have shown solid growth trends driven by glaucoma and dry eye products.

What challenges does the Tafluprost market face?

Despite strong revenue growth, profitability remains a challenge, particularly in regions like the Americas. Companies are focusing on cost optimization and structural reforms to address this issue.

Sources

1. 360iResearch: Tafluprost Eye Drops Market Size & Share 2025-2030
2. Santen Pharmaceutical: FY2023 Financial Results
3. Santen Pharmaceutical: Q3 FY2022 Financial Results
4. MarketResearchReports.com: Global Tafluprost Eye Drops Market Growth 2024-2030
5. Santen Pharmaceutical: FY2022 Financial Results