Acular Ls is a drug owned by Abbvie Inc. It is protected by 13 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 11 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 24, 2027. Details of Acular Ls's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8008338 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8008338 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Nov, 2027
(2 years from now) | Active |
|
US8541463 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Nov, 2024
(5 months ago) |
Expired
|
|
US8207215 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Nov, 2024
(5 months ago) |
Expired
|
|
US8377982 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Nov, 2024
(5 months ago) |
Expired
|
| US8648107 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US9216127 | Burial vault and method for customizing a burial vault |
May, 2024
(11 months ago) |
Expired
|
| US8377982 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US8207215 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US8906950 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US9216167 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US8946281 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months ago) |
Expired
|
| US8541463 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May, 2024
(11 months 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 Acular Ls's patents.
Latest Legal Activities on Acular Ls's Patents
Given below is the list of recent legal activities going on the following patents of Acular Ls.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Nov, 2023 | US8207215 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 16 Jun, 2023 | US9216127 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2023 | US9216167 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US8008338 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 May, 2022 | US8906950 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Mar, 2021 | US8541463 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Aug, 2020 | US8377982 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Dec, 2019 | US8207215 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 23 Dec, 2019 | US9216127 |
| Surcharge for late Payment, Small Entity | 23 Dec, 2019 | US9216127 |
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 Acular Ls and ongoing litigations to help you estimate the early arrival of Acular Ls generic.
Acular Ls's Litigations
Acular Ls been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 02, 2006, against patent number US8008338. The petitioner , challenged the validity of this patent, with Christopher A. Muller et al as the respondent. Click below to track the latest information on how companies are challenging Acular Ls's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8008338 | November, 2010 |
Decision
(29 Mar, 2011) | Christopher A. Muller et al | |
| US8008338 | August, 2006 |
Decision
(21 Dec, 2006) | Christopher A. Muller et al | |
US patents provide insights into the exclusivity only within the United States, but Acular Ls 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 Acular Ls's family patents as well as insights into ongoing legal events on those patents.
Acular Ls's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Acular Ls's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 24, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acular Ls Generic API suppliers:
Ketorolac Tromethamine is the generic name for the brand Acular Ls. 35 different companies have already filed for the generic of Acular Ls, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Acular Ls's generic
How can I launch a generic of Acular Ls before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Acular Ls's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Acular Ls'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 Acular Ls -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.004 | 28 Jan, 2005 | 1 | 05 Nov, 2009 | 05 May, 2011 | Extinguished |
Alternative Brands for Acular Ls
Acular Ls which is used for managing ocular pain and discomfort postoperatively and in various eye conditions., has several other brand drugs using the same active ingredient (Ketorolac Tromethamine). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ketorolac Tromethamine, Acular Ls's active ingredient. Check the complete list of approved generic manufacturers for Acular Ls
About Acular Ls
Acular Ls is a drug owned by Abbvie Inc. It is used for managing ocular pain and discomfort postoperatively and in various eye conditions. Acular Ls uses Ketorolac Tromethamine as an active ingredient. Acular Ls was launched by Abbvie in 2003.
Can you believe Acular Ls received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Acular Ls was approved by FDA for market use on 30 May, 2003.
Active Ingredient:
Acular Ls uses Ketorolac Tromethamine as the active ingredient. Check out other Drugs and Companies using Ketorolac Tromethamine ingredient
Treatment:
Acular Ls is used for managing ocular pain and discomfort postoperatively and in various eye conditions.
Dosage:
Acular Ls is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4% | SOLUTION/DROPS | Prescription | OPHTHALMIC |