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 three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-seven patent family members in thirty-one countries.

The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. Six 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:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	718
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for ZIOPTAN

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

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 three US patents.

Patents protecting ZIOPTAN

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	Y
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

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

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
Lithuania	2772249
Ukraine	102257	ОФТАЛЬМОЛОГИЧЕСКИЙ ВОДНЫЙ РАСТВОР ДЛЯ ЛЕЧЕНИЯ ГЛАЗНОЙ ГИПЕРТЕНЗИИ И ГЛАУКОМЫ;ОФТАЛЬМОЛОГІЧНИЙ ВОДНИЙ РОЗЧИН ДЛЯ ЛІКУВАННЯ ОЧНОЇ ГІПЕРТЕНЗІЇ ТА ГЛАУКОМИ (OPHTHALMIC AQUEOUS COMPOSITION FOR TREATING OCULAR HYPERTENSION AND GLAUCOMA)
Japan	2020073574	高眼圧症及び緑内障を治療するための方法及び組成物 (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	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	300407	Netherlands		300407, 20171222, EXPIRES: 20221221
0850926	91943	Luxembourg		91943, EXPIRES: 20221222