ZIOPTAN Drug Patent Profile

Which patents cover Zioptan, and what generic alternatives are available?

Zioptan is a drug marketed by Thea Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tafluprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zioptan

A generic version of ZIOPTAN was approved as tafluprost by MICRO LABS on August 19^th, 2019.

Summary for ZIOPTAN

International Patents:	81
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	428
Drug Prices:	Drug price information for ZIOPTAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZIOPTAN
What excipients (inactive ingredients) are in ZIOPTAN?	ZIOPTAN excipients list
DailyMed Link:	ZIOPTAN at DailyMed

See drug prices for ZIOPTAN

Pharmacology for ZIOPTAN

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

Paragraph IV (Patent) Challenges for ZIOPTAN

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 ZIOPTAN

ZIOPTAN is protected by two 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	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes	10,864,159		Y
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	AT	RX	Yes	Yes	9,999,593		Y

Expired US Patents for ZIOPTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514-001	Feb 10, 2012	5,886,035

International Patents for ZIOPTAN

When does loss-of-exclusivity occur for ZIOPTAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Japan

Jordan

Lithuania

Malaysia

Mexico

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZIOPTAN around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120351
Germany	69716226
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)

Supplementary Protection Certificates for ZIOPTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0850926	SPC013/2011	Ireland		SPC013/2011: 20110808, EXPIRES: 20221221
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
0850926	CA 2008 00041	Denmark
0850926	91943	Luxembourg		91943, EXPIRES: 20221222

ZIOPTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZIOPTAN

Introduction to ZIOPTAN

ZIOPTAN, also known as tafluprost ophthalmic solution, is a preservative-free prostaglandin analog approved by the U.S. Food and Drug Administration (FDA) for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension[4].

Market Context: Ophthalmic Drugs

The global ophthalmic drugs market is experiencing significant growth, driven by the rising prevalence of retinal disorders, advancements in drug delivery, and increased research and development activities. The market was estimated at USD 37.82 billion in 2023 and is projected to grow at a CAGR of 8.34% from 2024 to 2030[3].

Product Approval and Launch

ZIOPTAN was approved by the FDA in February 2012 and was made available to customers in March of the same year. This approval marked a significant milestone, providing a new, effective option for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension[4].

Clinical Efficacy and Safety

Clinical studies have demonstrated ZIOPTAN's powerful IOP-lowering effects. In studies of up to two years, ZIOPTAN lowered IOP by 6-8 mmHg at 3 and 6 months from a baseline pressure of 23-26 mmHg. The drug has also been associated with changes in eyelashes and iris pigmentation, which are generally reversible or manageable[4].

Licensing and Commercial Rights

Merck and Santen Pharmaceutical Co., Ltd. entered into a worldwide licensing agreement for tafluprost in 2009. Merck has exclusive commercial rights in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India, and Australia. Santen retains commercial rights in Germany, most countries in Eastern Europe, Northern Europe, and the Asia Pacific region, including Japan[4].

Market Segmentation and Growth

Geographic Market

North America dominated the ophthalmic drugs market in 2023, accounting for 44.99% of the global share. This is due to the high prevalence of retinal diseases and favorable government initiatives in the region. However, the Asia Pacific region is anticipated to witness the fastest growth rate, driven by the increasing burden of ophthalmic disorders and rising consumer awareness[3].

Drug Class

Prostaglandin analogs, like ZIOPTAN, are often used as a first-line treatment for lowering intraocular pressure in patients with open-angle glaucoma. The segment growth is supported by the rising prevalence of retinal disorders globally. Anti-VEGF agents, another significant segment, accounted for 32.71% of the global revenue in 2023, but prostaglandin analogs remain a crucial part of the treatment landscape[3].

Financial Impact

Revenue and Sales

While specific financial data for ZIOPTAN is not provided in the sources, the overall ophthalmic drugs market is expected to see significant growth. The approval and launch of ZIOPTAN contributed to the revenue streams of both Merck and Santen Pharmaceutical. For instance, Santen's glaucoma market share increased due to the sales growth of similar products like Tapros (another name for tafluprost in certain markets)[1].

R&D and Operational Costs

The development and launch of ZIOPTAN involved significant research and development costs. Santen Pharmaceutical, for example, increased its R&D expenses due to the progress of late-stage clinical developments, which would include costs associated with drugs like ZIOPTAN[1].

Competitive Landscape

The ophthalmic drugs market is characterized by a high degree of innovation, with several key players. Merck's introduction of ZIOPTAN added to the competitive landscape, offering a preservative-free option that differentiates it from other prostaglandin analogs. The market also sees competition from generic drugs, which are projected to witness the fastest growth rate due to their cost-effectiveness and the patent expiry of branded drugs[3].

Regulatory and Safety Considerations

ZIOPTAN's approval was based on efficacy and safety results from five controlled clinical studies. The drug has specific warnings and precautions, including the potential for increased pigmentation of the iris, periorbital tissue, and eyelashes. These considerations are crucial for its continued market presence and regulatory compliance[4].

Future Outlook

The future outlook for ZIOPTAN is tied to the broader trends in the ophthalmic drugs market. With the market expected to grow at a CAGR of 8.34% from 2024 to 2030, ZIOPTAN is likely to remain a significant player, especially given its unique preservative-free formulation. The emergence of new technologies and drug delivery mechanisms, such as gene therapies, will continue to shape the market and potentially influence the trajectory of ZIOPTAN and similar products[3].

Key Takeaways

• Market Growth: The ophthalmic drugs market is growing rapidly, driven by rising prevalence of retinal disorders and advancements in drug delivery.
• Product Differentiation: ZIOPTAN's preservative-free formulation differentiates it in the market, offering a unique option for patients.
• Geographic Performance: North America is a key market, but the Asia Pacific region is expected to grow rapidly.
• Financial Impact: Significant R&D costs were involved in ZIOPTAN's development, but it contributes to the revenue streams of Merck and Santen Pharmaceutical.
• Regulatory Compliance: ZIOPTAN's safety profile and regulatory approvals are critical for its market presence.

FAQs

What is ZIOPTAN used for?

ZIOPTAN (tafluprost ophthalmic solution) is used for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension[4].

Who are the key players involved in the commercialization of ZIOPTAN?

Merck and Santen Pharmaceutical Co., Ltd. are the key players involved in the commercialization of ZIOPTAN, with Merck holding exclusive commercial rights in several regions and Santen retaining rights in others[4].

What are the potential side effects of ZIOPTAN?

ZIOPTAN can cause changes in eyelashes and iris pigmentation, and it may also exacerbate intraocular inflammation or contribute to macular edema in certain patients[4].

How does ZIOPTAN fit into the broader ophthalmic drugs market?

ZIOPTAN is part of the prostaglandin analog segment, which is a significant part of the ophthalmic drugs market. The market is growing due to rising prevalence of retinal disorders and advancements in drug delivery[3].

What is the forecasted growth rate of the ophthalmic drugs market?

The ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030[3].

Sources

1. Santen Pharmaceutical: FY 2012 Third Quarter Results[1]
2. Santen Pharmaceutical: News Release[2]
3. Grand View Research: Ophthalmic Drugs Market Size & Share | Industry Report 2030[3]
4. Merck: FDA Approves ZIOPTAN™ (tafluprost ophthalmic solution)[4]