Zioptan Patent Expiration

Zioptan is a drug owned by Thea Pharma Inc. It is protected by 3 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 1 has expired. Zioptan's patents have been open to challenges since 11 February, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be May 28, 2029. Details of Zioptan's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10864159 Method and composition for treating ocular hypertension and glaucoma
May, 2029

(4 years from now)

Active
US9999593 Method and composition for treating ocular hypertension and glaucoma
May, 2029

(4 years from now)

Active
US5886035 Difluoroprostaglandin derivatives and their use
Dec, 2017

(6 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zioptan's patents.

Given below is the list of recent legal activities going on the following patents of Zioptan.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 29 May, 2024 US10864159
Payment of Maintenance Fee, 4th Year, Large Entity 01 Dec, 2021 US9999593
Patent Issue Date Used in PTA Calculation 15 Dec, 2020 US10864159
Recordation of Patent Grant Mailed 15 Dec, 2020 US10864159
Email Notification 25 Nov, 2020 US10864159
Issue Notification Mailed 24 Nov, 2020 US10864159
Application Is Considered Ready for Issue 12 Nov, 2020 US10864159
Dispatch to FDC 12 Nov, 2020 US10864159
Issue Fee Payment Received 11 Nov, 2020 US10864159
Issue Fee Payment Verified 11 Nov, 2020 US10864159


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Zioptan and ongoing litigations to help you estimate the early arrival of Zioptan generic.

Zioptan's Litigations

Zioptan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 12, 2017, against patent number US5886035. The petitioner Micro Labs Limited, challenged the validity of this patent, with Santen Pharmaceutical Co., Ltd. as the respondent. Click below to track the latest information on how companies are challenging Zioptan's patents.

Last updated on November 12, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US5886035 May, 2017 FWD Entered
(27 Nov, 2018)
Santen Pharmaceutical Co., Ltd. Micro Labs Limited


FDA has granted some exclusivities to Zioptan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zioptan, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zioptan.

Exclusivity Information

Zioptan holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Zioptan's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Feb 10, 2017

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Several oppositions have been filed on Zioptan's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zioptan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zioptan patents.

Zioptan's Oppositions Filed in EPO

Zioptan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 02, 2018, by Cooke, Richard. This opposition was filed on patent number EP14001862A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP20164602A Oct, 2022 Becker, Eberhard Granted and Under Opposition
EP20164602A Oct, 2022 De Gregori, Antonella Granted and Under Opposition
EP20164602A Oct, 2022 Cooke, Richard Granted and Under Opposition
EP17000440A Jan, 2021 Cooke, Richard Granted and Under Opposition
EP14001862A Feb, 2018 Cooke, Richard Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Zioptan is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zioptan's family patents as well as insights into ongoing legal events on those patents.

Zioptan's Family Patents

Zioptan has patent protection in a total of 26 countries. It's US patent count contributes only to 5.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Zioptan.

Family Patents

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Generic Launch

Generic Release Date:

Zioptan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 28, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Zioptan Generic API suppliers:

Tafluprost is the generic name for the brand Zioptan. 3 different companies have already filed for the generic of Zioptan, with Ingenus Pharms Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zioptan's generic

How can I launch a generic of Zioptan before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Zioptan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zioptan's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Zioptan -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.000015 10 Feb, 2016 2 19 Aug, 2019 18 Dec, 2022 Eligible Deferred

Alternative Brands for Zioptan

Zioptan which is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Alcon Labs Inc
Simbrinza Used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.





About Zioptan

Zioptan is a drug owned by Thea Pharma Inc. It is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Zioptan uses Tafluprost as an active ingredient. Zioptan was launched by Thea Pharma in 2012.

Approval Date:

Zioptan was approved by FDA for market use on 10 February, 2012.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zioptan is 10 February, 2012, its NCE-1 date is estimated to be 11 February, 2016.

Active Ingredient:

Zioptan uses Tafluprost as the active ingredient. Check out other Drugs and Companies using Tafluprost ingredient

Treatment:

Zioptan is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Dosage:

Zioptan is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.0015% SOLUTION/DROPS Prescription OPHTHALMIC