Pataday Twice Daily Relief is a drug owned by Alcon Laboratories Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 06, 2015. Details of Pataday Twice 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). | |||
|
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
|
US patents provide insights into the exclusivity only within the United States, but Pataday Twice 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 Twice Daily Relief's family patents as well as insights into ongoing legal events on those patents.
Pataday Twice Daily Relief's Family Patents
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Generic Launch
Generic Release Date:
Pataday Twice Daily Relief's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 06, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pataday Twice Daily Relief Generic API suppliers:
Olopatadine Hydrochloride is the generic name for the brand Pataday Twice Daily Relief. 18 different companies have already filed for the generic of Pataday Twice 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 Twice Daily Relief's generic
How can I launch a generic of Pataday Twice Daily Relief before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pataday Twice Daily Relief's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pataday Twice 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 Twice Daily Relief -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.001 | 17 Jul, 2006 | 1 | 07 Dec, 2015 | 06 Jun, 2015 | Extinguished |
Alternative Brands for Pataday Twice Daily Relief
Pataday Twice Daily Relief which is used for treating allergic eye diseases in humans., has several other brand drugs 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 | |
|---|---|---|
| Alcon Labs Inc |
| |
| Glenmark Speclt |
| |
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Olopatadine Hydrochloride, Pataday Twice Daily Relief's active ingredient. Check the complete list of approved generic manufacturers for Pataday Twice Daily Relief
About Pataday Twice Daily Relief
Pataday Twice Daily Relief is a drug owned by Alcon Laboratories Inc. It is used for treating allergic eye diseases in humans. Pataday Twice Daily Relief uses Olopatadine Hydrochloride as an active ingredient. Pataday Twice Daily Relief was launched by Alcon Labs Inc in 1996.
Approval Date:
Pataday Twice Daily Relief was approved by FDA for market use on 18 December, 1996.
Active Ingredient:
Pataday Twice Daily Relief uses Olopatadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Olopatadine Hydrochloride ingredient
Treatment:
Pataday Twice Daily Relief is used for treating allergic eye diseases in humans.
Dosage:
Pataday Twice 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 0.1% BASE | SOLUTION/DROPS | Over the counter | OPHTHALMIC |