Acuvail is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2029. Details of Acuvail's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7842714 | Ketorolac tromethamine compositions for treating ocular pain |
Aug, 2029
(5 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8992952 | Compositions for delivery of therapeutics into the eyes and methods for making and using same |
Aug, 2024
(8 days from now) | Active |
| US8512717 | Compositions for delivery of therapeutics into the eyes and methods for making and using same |
Mar, 2028
(3 years from now) | Active |
| US9192571 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Mar, 2028
(3 years from now) | Active |
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 Acuvail's patents.
Latest Legal Activities on Acuvail's Patents
Given below is the list of recent legal activities going on the following patents of Acuvail.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Apr, 2023 | US9192571 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2022 | US7842714 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2021 | US8512717 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 May, 2019 | US9192571 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 May, 2018 | US7842714 |
| Post Issue Communication - Certificate of Correction | 16 Feb, 2016 | US9192571 |
| Patent Issue Date Used in PTA Calculation | 24 Nov, 2015 | US9192571 |
| Recordation of Patent Grant Mailed | 24 Nov, 2015 | US9192571 |
| Email Notification | 05 Nov, 2015 | US9192571 |
| Issue Notification Mailed | 04 Nov, 2015 | US9192571 |
FDA has granted several exclusivities to Acuvail. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Acuvail, 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 Acuvail.
Exclusivity Information
Acuvail holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Acuvail's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 22, 2012 |
Several oppositions have been filed on Acuvail'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 Acuvail's generic, the next section provides detailed information on ongoing and past EP oppositions related to Acuvail patents.
Acuvail's oppositions filed in EPO
Acuvail has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 07, 2010, by Alcon Laboratories, Inc.. This opposition was filed on patent number EP04780382A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04780382A | Jul, 2010 | ALCON LABORATORIES, INC. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Acuvail 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 Acuvail's family patents as well as insights into ongoing legal events on those patents.
Acuvail's family patents
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Generic Launch
Generic Release Date:
Acuvail's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 15, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acuvail Generics:
Ketorolac Tromethamine is the generic name for the brand Acuvail. 35 different companies have already filed for the generic of Acuvail, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Acuvail's generic
How can I launch a generic of Acuvail before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Acuvail's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Acuvail'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 Acuvail -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0045 | 24 Aug, 2011 | 1 | 10 Feb, 2014 | 15 Aug, 2029 | Eligible |
About Acuvail
Acuvail is a drug owned by Abbvie Inc. Acuvail uses Ketorolac Tromethamine as an active ingredient. Acuvail was launched by Abbvie in 2009.
Market Authorisation Date:
Acuvail was approved by FDA for market use on 22 July, 2009.
Active Ingredient:
Acuvail uses Ketorolac Tromethamine as the active ingredient. Check out other Drugs and Companies using Ketorolac Tromethamine ingredient
Dosage:
Acuvail is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.45% | SOLUTION/DROPS | Prescription | OPHTHALMIC |