Istalol is a drug owned by Bausch And Lomb 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 Nov 16, 2018. Details of Istalol'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). | |||
| US6645963 | Prolonged-action eye drop |
Nov, 2018
(6 years ago) |
Expired
|
| US6335335 | Prolonged-action eye drop |
Nov, 2018
(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 Istalol's patents.
Latest Legal Activities on Istalol's Patents
Given below is the list of recent legal activities going on the following patents of Istalol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 12 Nov, 2003 | US6645963 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Nov, 2003 | US6645963 |
| Issue Notification Mailed Critical | 23 Oct, 2003 | US6645963 |
| Receipt into Pubs | 07 Oct, 2003 | US6645963 |
| Application Is Considered Ready for Issue Critical | 03 Oct, 2003 | US6645963 |
| Receipt into Pubs | 22 Sep, 2003 | US6645963 |
| Issue Fee Payment Verified Critical | 08 Jul, 2003 | US6645963 |
| Issue Fee Payment Received Critical | 08 Jul, 2003 | US6645963 |
| Receipt into Pubs | 26 Jun, 2003 | US6645963 |
| Workflow - File Sent to Contractor | 26 Jun, 2003 | US6645963 |
US patents provide insights into the exclusivity only within the United States, but Istalol 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 Istalol's family patents as well as insights into ongoing legal events on those patents.
Istalol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Istalol's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 16, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Istalol Generic API suppliers:
Timolol Maleate is the generic name for the brand Istalol. 31 different companies have already filed for the generic of Istalol, with Epic Pharma Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Istalol's generic
How can I launch a generic of Istalol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Istalol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Istalol'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 Istalol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005 | 19 Oct, 2012 | 1 | 17 Apr, 2015 | 16 Nov, 2018 | Eligible |
Alternative Brands for Istalol
There are several other brand drugs using the same active ingredient (Timolol Maleate) as Istalol. 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 | |
|---|---|---|
| Abbvie |
| |
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Timolol Maleate, Istalol's active ingredient. Check the complete list of approved generic manufacturers for Istalol
About Istalol
Istalol is a drug owned by Bausch And Lomb Inc. Istalol uses Timolol Maleate as an active ingredient. Istalol was launched by Bausch And Lomb in 2004.
Approval Date:
Istalol was approved by FDA for market use on 04 June, 2004.
Active Ingredient:
Istalol uses Timolol Maleate as the active ingredient. Check out other Drugs and Companies using Timolol Maleate ingredient
Dosage:
Istalol is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.5% BASE | SOLUTION/DROPS | Prescription | OPHTHALMIC |