Exservan is a drug owned by Aquestive Therapeutics Inc. It is protected by 2 US drug patents filed in 2020 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 03, 2024. Details of Exservan'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). | |||
| US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| US8765167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb, 2024
(1 year, 4 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 Exservan's patents.
Latest Legal Activities on Exservan's Patents
Given below is the list of recent legal activities going on the following patents of Exservan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Jun, 2021 | US8603514 (Litigated) |
| Request for Trial Denied Critical | 20 Oct, 2017 | US8603514 (Litigated) |
| Termination or Final Written Decision | 06 Oct, 2017 | US8603514 (Litigated) |
| Petition Requesting Trial | 12 Jun, 2017 | US8603514 (Litigated) |
| Petition Requesting Trial | 09 Jun, 2017 | US8603514 (Litigated) |
| Request for Trial Granted Critical | 12 May, 2017 | US8603514 (Litigated) |
| Request for Trial Denied Critical | 05 Dec, 2016 | US8603514 (Litigated) |
| Petition Requesting Trial | 04 Nov, 2016 | US8603514 (Litigated) |
| Petition Requesting Trial | 06 Jun, 2016 | US8603514 (Litigated) |
| Request for Trial Denied Critical | 23 May, 2016 | US8603514 (Litigated) |
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 Exservan and ongoing litigations to help you estimate the early arrival of Exservan generic.
Exservan's Litigations
Exservan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 28, 2014, against patent number US8765167. The petitioner BioDelivery Sciences International, Inc., challenged the validity of this patent, with MonoSol Rx, LLC. as the respondent. Click below to track the latest information on how companies are challenging Exservan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Par Pharmaceutical, Inc. |
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Dr. Reddy’s Laboratories, Inc. |
| US8603514 | November, 2016 |
Terminated-Settled
(06 Oct, 2017) | MonoSol Rx, LLC et al. | Mylan Technologies, Inc. et al. |
| US8603514 | May, 2016 |
Terminated-Denied
(05 Dec, 2016) | MonoSol Rx, LLC | Dr. Reddy's Laboratories, Inc. |
| US8603514 | December, 2015 |
Terminated-Denied
(23 May, 2016) | MONOSOL RX LLC | Teva Pharmaceuticals USA Inc |
| US8765167 | October, 2014 |
FWD Entered
(24 Mar, 2016) | MonoSol Rx, LLC. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Terminated-Settled
(24 Mar, 2016) | MonoSol Rx, LLC. et al. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Terminated-Denied
(20 May, 2015) | MonoSol Rx, LLC. | BioDelivery Sciences International, Inc. |
Several oppositions have been filed on Exservan'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 Exservan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Exservan patents.
Exservan's Oppositions Filed in EPO
Exservan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 11, 2012, by Lts Lohmann Therapie-Systeme Ag. This opposition was filed on patent number EP02801042A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11157819A | Jun, 2014 | Ahrens, Gabriele | Patent maintained as amended |
| EP02782151A | Jun, 2013 | Acino Pharma AG | Revoked |
| EP02782151A | Jun, 2013 | Germann, Sandra | Revoked |
| EP02801042A | Sep, 2012 | Ahrens, Gabriele | Patent maintained as amended |
| EP02801042A | Sep, 2012 | LTS LOHMANN Therapie-Systeme AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Exservan 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 Exservan's family patents as well as insights into ongoing legal events on those patents.
Exservan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exservan's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 03, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exservan Generic API suppliers:
Riluzole is the generic name for the brand Exservan. 8 different companies have already filed for the generic of Exservan, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exservan's generic
Alternative Brands for Exservan
There are several other brand drugs using the same active ingredient (Riluzole) as Exservan. 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 | |
|---|---|---|
| Covis |
| |
| Italfarmaco Sa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Riluzole, Exservan's active ingredient. Check the complete list of approved generic manufacturers for Exservan
About Exservan
Exservan is a drug owned by Aquestive Therapeutics Inc. Exservan uses Riluzole as an active ingredient. Exservan was launched by Aquestive in 2019.
Approval Date:
Exservan was approved by FDA for market use on 22 November, 2019.
Active Ingredient:
Exservan uses Riluzole as the active ingredient. Check out other Drugs and Companies using Riluzole ingredient
Dosage:
Exservan is available in film form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | FILM | Discontinued | ORAL |