Exservan Patent Expiration

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

(7 months ago)

Expired
US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Feb, 2024

(9 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.

Given below is the list of recent legal activities going on the following patents of Exservan.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 08 Jun, 2021 US8603514 (Litigated)
Request for Trial Denied 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 12 May, 2017 US8603514 (Litigated)
Request for Trial Denied 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 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.

Last updated on November 19, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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.

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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
Patent litigations
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

Exservan has patent protection in a total of 19 countries. It's US patent count contributes only to 48.1% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Exservan.

Family Patents

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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
Rilutek
Italfarmaco Sa
Tiglutik Kit


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