Akten is a drug owned by Thea Pharma Inc. It is protected by 1 US drug patent filed in 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 24, 2026. Details of Akten'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). | |||
| US8759401 | Aqueous gel formulation and method for inducing topical anesthesia |
Jul, 2026
(1 year, 7 months 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 Akten's patents.
Latest Legal Activities on Akten's Patents
Given below is the list of recent legal activities going on the following patents of Akten.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 23 Sep, 2022 | US8759401 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 Sep, 2022 | US8759401 |
| Email Notification Critical | 09 Sep, 2022 | US8759401 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Sep, 2022 | US8759401 |
| 7.5 yr surcharge - late pmt w/in 6 mo, Large Entity | 17 Jan, 2022 | US8759401 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2022 | US8759401 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Dec, 2017 | US8759401 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US8759401 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jun, 2014 | US8759401 |
| Recordation of Patent Grant Mailed Critical | 24 Jun, 2014 | US8759401 |
FDA has granted several exclusivities to Akten. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Akten, 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 Akten.
Exclusivity Information
Akten holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Akten's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Oct 07, 2011 |
US patents provide insights into the exclusivity only within the United States, but Akten 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 Akten's family patents as well as insights into ongoing legal events on those patents.
Akten's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Akten's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 24, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Akten Generic API suppliers:
Lidocaine Hydrochloride is the generic name for the brand Akten. 46 different companies have already filed for the generic of Akten, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Akten's generic
Alternative Brands for Akten
Akten which is used for inducing topical anesthesia in the eye., has several other brand drugs using the same active ingredient (Lidocaine 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 | |
|---|---|---|
| Powder Pharms |
| |
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lidocaine Hydrochloride, Akten's active ingredient. Check the complete list of approved generic manufacturers for Akten
About Akten
Akten is a drug owned by Thea Pharma Inc. It is used for inducing topical anesthesia in the eye. Akten uses Lidocaine Hydrochloride as an active ingredient. Akten was launched by Thea Pharma in 2008.
Approval Date:
Akten was approved by FDA for market use on 07 October, 2008.
Active Ingredient:
Akten uses Lidocaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Lidocaine Hydrochloride ingredient
Treatment:
Akten is used for inducing topical anesthesia in the eye.
Dosage:
Akten is available in gel form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.5% | GEL | Prescription | OPHTHALMIC |