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
(7 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 15 Dec, 2020 | US10864159 |
| Recordation of Patent Grant Mailed Critical | 15 Dec, 2020 | US10864159 |
| Email Notification Critical | 25 Nov, 2020 | US10864159 |
| Issue Notification Mailed Critical | 24 Nov, 2020 | US10864159 |
| Application Is Considered Ready for Issue Critical | 12 Nov, 2020 | US10864159 |
| Dispatch to FDC | 12 Nov, 2020 | US10864159 |
| Issue Fee Payment Received Critical | 11 Nov, 2020 | US10864159 |
| Issue Fee Payment Verified Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 |
| |||
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 |