Pataday Once Daily Relief is a drug owned by Alcon Laboratories Inc. It is protected by 8 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 19, 2032. Details of Pataday Once Daily Relief'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). | |||
| US8791154 | High concentration olopatadine ophthalmic composition |
May, 2032
(7 years from now) | Active |
| US9533053 | High concentration olopatadine ophthalmic composition |
May, 2032
(7 years from now) | Active |
|
US6995186 (Pediatric) | Olopatadine formulations for topical administration |
May, 2024
(5 months ago) |
Expired
|
| US6995186 | Olopatadine formulations for topical administration |
Nov, 2023
(11 months ago) |
Expired
|
|
US7402609 (Pediatric) | Olopatadine formulations for topical administration |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US7402609 | Olopatadine formulations for topical administration |
Jun, 2022
(2 years ago) |
Expired
|
|
US5641805 (Pediatric) | Topical ophthalmic formulations for treating allergic eye diseases |
Dec, 2015
(8 years ago) |
Expired
|
| US5641805 | Topical ophthalmic formulations for treating allergic eye diseases |
Jun, 2015
(9 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 Pataday Once Daily Relief's patents.
Latest Legal Activities on Pataday Once Daily Relief's Patents
Given below is the list of recent legal activities going on the following patents of Pataday Once Daily Relief.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jun, 2024 | US9533053 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jan, 2022 | US8791154 (Litigated) |
| Request for Trial Denied Critical | 06 Aug, 2020 | US9533053 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Jun, 2020 | US9533053 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Jan, 2020 | US7402609 (Litigated) |
| Petition Requesting Trial | 24 Dec, 2019 | US9533053 |
| Termination or Final Written Decision | 17 Sep, 2018 | US8791154 (Litigated) |
| Termination or Final Written Decision | 17 Sep, 2018 | US9533053 |
| Petition Requesting Trial | 05 Jun, 2018 | US8791154 (Litigated) |
| Petition Requesting Trial | 05 Jun, 2018 | US9533053 |
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 Pataday Once Daily Relief and ongoing litigations to help you estimate the early arrival of Pataday Once Daily Relief generic.
Pataday Once Daily Relief's Litigations
Pataday Once Daily Relief been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 18, 2016, against patent number US8791154. The petitioner Apotex, Inc., challenged the validity of this patent, with Alcon Research, Ltd. as the respondent. Click below to track the latest information on how companies are challenging Pataday Once Daily Relief's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9533053 | December, 2019 |
Terminated-Denied
(06 Aug, 2020) | Novartis AG | AYLA PHARMA LLC |
| US8791154 | June, 2018 |
Terminated-Settled
(17 Sep, 2018) | Alcon Research Ltd. | Cipla Limited |
| US9533053 | June, 2018 |
Terminated-Settled
(17 Sep, 2018) | Alcon Research Ltd. | Cipla Limited |
| US8791154 | February, 2016 |
Terminated-Settled
(30 Nov, 2016) | Alcon Research, Ltd. | Argentum Pharmaceuticals, LLC |
| US8791154 | August, 2016 |
Terminated-Settled
(30 Nov, 2016) | Alcon Research, Ltd. | Apotex, Inc. |
FDA has granted some exclusivities to Pataday Once Daily Relief. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pataday Once Daily Relief, 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 Pataday Once Daily Relief.
Exclusivity Information
Pataday Once Daily Relief holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Pataday Once Daily Relief's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 30, 2018 |
| Pediatric Exclusivity(PED) | Jul 30, 2018 |
US patents provide insights into the exclusivity only within the United States, but Pataday Once Daily Relief 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 Pataday Once Daily Relief's family patents as well as insights into ongoing legal events on those patents.
Pataday Once Daily Relief's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pataday Once Daily Relief's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pataday Once Daily Relief Generic API suppliers:
Olopatadine Hydrochloride is the generic name for the brand Pataday Once Daily Relief. 18 different companies have already filed for the generic of Pataday Once Daily Relief, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pataday Once Daily Relief's generic
How can I launch a generic of Pataday Once Daily Relief before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pataday Once Daily Relief's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pataday Once Daily Relief'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 Pataday Once Daily Relief -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.002 | 08 Sep, 2008 | 1 | 13 Jul, 2015 | 12 Nov, 2023 | Eligible |
| 0.007 | 10 Sep, 2015 | 1 | 19 Feb, 2020 | 19 May, 2032 | Non-forfeiture |
Alternative Brands for Pataday Once Daily Relief
Pataday Once Daily Relief which is used for treating allergic conjunctivitis and relieving ocular itching associated with allergic conjunctivitis., has several other brand drugs in the same treatment category and using the same active ingredient (Olopatadine Hydrochloride). 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 | ||
|---|---|---|---|---|
| Harrow Eye |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Olopatadine Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Alcon Labs Inc |
| |
| Glenmark Speclt |
| |
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Olopatadine Hydrochloride, Pataday Once Daily Relief's active ingredient. Check the complete list of approved generic manufacturers for Pataday Once Daily Relief
About Pataday Once Daily Relief
Pataday Once Daily Relief is a drug owned by Alcon Laboratories Inc. It is used for treating allergic conjunctivitis and relieving ocular itching associated with allergic conjunctivitis. Pataday Once Daily Relief uses Olopatadine Hydrochloride as an active ingredient. Pataday Once Daily Relief was launched by Alcon Labs Inc in 2015.
Approval Date:
Pataday Once Daily Relief was approved by FDA for market use on 30 January, 2015.
Active Ingredient:
Pataday Once Daily Relief uses Olopatadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Olopatadine Hydrochloride ingredient
Treatment:
Pataday Once Daily Relief is used for treating allergic conjunctivitis and relieving ocular itching associated with allergic conjunctivitis.
Dosage:
Pataday Once Daily Relief is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.7% BASE | SOLUTION/DROPS | Over the counter | OPHTHALMIC |
| EQ 0.2% BASE | SOLUTION/DROPS | Over the counter | OPHTHALMIC |