Dextenza is a drug owned by Ocular Therapeutix Inc. It is protected by 4 US drug patents filed from 2019 to 2022. Out of these, 3 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 16, 2037. Details of Dextenza'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). | |||
| US11458041 | Punctal plug and bioadhesives |
Nov, 2037
(12 years from now) | Active |
| US8409606 | Drug delivery through hydrogel plugs |
May, 2030
(5 years from now) | Active |
| US8563027 | Drug delivery through hydrogel plugs |
Feb, 2030
(5 years from now) | Active |
| US9254267 | Composite hydrogel drug delivery systems |
Sep, 2024
(2 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 Dextenza's patents.
Latest Legal Activities on Dextenza's Patents
Given below is the list of recent legal activities going on the following patents of Dextenza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 04 Oct, 2022 | US11458041 |
| Recordation of Patent Grant Mailed Critical | 04 Oct, 2022 | US11458041 |
| Email Notification Critical | 15 Sep, 2022 | US11458041 |
| Issue Notification Mailed Critical | 14 Sep, 2022 | US11458041 |
| Dispatch to FDC | 30 Aug, 2022 | US11458041 |
| Application Is Considered Ready for Issue Critical | 30 Aug, 2022 | US11458041 |
| Issue Fee Payment Received Critical | 26 Aug, 2022 | US11458041 |
| Issue Fee Payment Verified Critical | 26 Aug, 2022 | US11458041 |
| Email Notification Critical | 02 Aug, 2022 | US11458041 |
| Mail Notice of Allowance Critical | 02 Aug, 2022 | US11458041 |
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 Dextenza and ongoing litigations to help you estimate the early arrival of Dextenza generic.
Dextenza's Litigations
Dextenza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 20, 2012, against patent number US9254267. The petitioner , challenged the validity of this patent, with Amarpreet S. Sawhney as the respondent. Click below to track the latest information on how companies are challenging Dextenza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9254267 | August, 2012 |
Decision
(23 Jul, 2015) | Amarpreet S. Sawhney | |
FDA has granted some exclusivities to Dextenza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dextenza, 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 Dextenza.
Exclusivity Information
Dextenza holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Dextenza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 30, 2021 |
| New Indication(I-800) | Jun 20, 2022 |
| New Indication(I-876) | Oct 07, 2024 |
US patents provide insights into the exclusivity only within the United States, but Dextenza 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 Dextenza's family patents as well as insights into ongoing legal events on those patents.
Dextenza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dextenza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 16, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dextenza Generic API suppliers:
Dexamethasone is the generic name for the brand Dextenza. 30 different companies have already filed for the generic of Dextenza, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dextenza's generic
Alternative Brands for Dextenza
Dextenza which is used for post-operative pain and inflammation in the eyes after surgery., has several other brand drugs using the same active ingredient (Dexamethasone). 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 |
| |
| Dexcel |
| |
| Eyepoint Pharms |
| |
| Harrow Eye |
| |
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexamethasone, Dextenza's active ingredient. Check the complete list of approved generic manufacturers for Dextenza
About Dextenza
Dextenza is a drug owned by Ocular Therapeutix Inc. It is used for post-operative pain and inflammation in the eyes after surgery. Dextenza uses Dexamethasone as an active ingredient. Dextenza was launched by Ocular Therapeutix in 2018.
Approval Date:
Dextenza was approved by FDA for market use on 30 November, 2018.
Active Ingredient:
Dextenza uses Dexamethasone as the active ingredient. Check out other Drugs and Companies using Dexamethasone ingredient
Treatment:
Dextenza is used for post-operative pain and inflammation in the eyes after surgery.
Dosage:
Dextenza is available in insert form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4MG | INSERT | Prescription | OPHTHALMIC |