Aquestive Drug Patent Portfolio

Aquestive owns 3 orange book drugs protected by 5 US patents Given below is the list of Aquestive's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11273131 Pharmaceutical compositions with enhanced permeation 18 Jun, 2038
Active
US9095577 Stabilized amine-containing actives in oral film compositions 13 Jul, 2030
Active
US8580830 Non-mucoadhesive film dosage forms 23 Nov, 2029
Active
US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions 03 Apr, 2024 Expired
US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions 20 Feb, 2024 Expired


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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 03 Sep, 2025 US11273131
Maintenance Fee Reminder Mailed 28 Jul, 2025 US8603514 (Litigated)
Maintenance Fee Reminder Mailed 30 Jun, 2025 US8580830
Payment of Maintenance Fee, 8th Year, Large Entity 30 Jan, 2023 US9095577
Patent Issue Date Used in PTA Calculation 15 Mar, 2022 US11273131
Recordation of Patent Grant Mailed 15 Mar, 2022 US11273131
Email Notification 24 Feb, 2022 US11273131
Issue Notification Mailed 23 Feb, 2022 US11273131
Application Is Considered Ready for Issue 15 Feb, 2022 US11273131
Dispatch to FDC 15 Feb, 2022 US11273131
Mailing Corrected Notice of Allowability 14 Feb, 2022 US11273131
Email Notification 14 Feb, 2022 US11273131
Corrected Notice of Allowability 27 Jan, 2022 US11273131
Pubs Case Remand to TC 25 Jan, 2022 US11273131
Printer Rush- No mailing 13 Jan, 2022 US11273131


Aquestive's Drug Patent Litigations

Aquestive's drugs have 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. et al. as the respondent. Click below to track the latest information on how companies are challenging Aquestive's patents.

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8603514 June, 2017 Institution Denied
(20 Oct, 2017)
MonoSol Rx, LLC et al. Par Pharmaceutical, Inc. et al.
US8603514 June, 2017 Institution Denied
(20 Oct, 2017)
MonoSol Rx, LLC et al. Dr. Reddy’s Laboratories, Inc. et al.
US8603514 November, 2016 Terminated-Settled
(06 Oct, 2017)
MonoSol Rx, LLC et al. Mylan Technologies, Inc. et al.
US8603514 May, 2016 Institution Denied
(05 Dec, 2016)
MonoSol Rx, LLC et al. Dr. Reddy's Laboratories, Inc. et al.
US8603514 December, 2015 Institution Denied
(23 May, 2016)
MONOSOL RX LLC et al. Teva Pharmaceuticals USA Inc
US8765167 October, 2014 Final Written Decision
(24 Mar, 2016)
MonoSol Rx, LLC. et al. BioDelivery Sciences International, Inc.
US8765167 October, 2014 Terminated-Settled
(24 Mar, 2016)
MonoSol Rx, LLC. et al. BioDelivery Sciences International, Inc.
US8765167 October, 2014 Institution Denied
(20 May, 2015)
MonoSol Rx, LLC. et al. BioDelivery Sciences International, Inc.


Aquestive Drug Patents' Oppositions Filed in EPO

Aquestive drug patents have 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


Aquestive's Family Patents

Aquestive drugs have patent protection in a total of 23 countries. It's US patent count contributes only to 46.8% of its total global patent coverage. 5 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.

Family Patents



Recent FDA approvals and tentative approvals for Aquestive

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.

Innovator drugs

Includes innovator drug submissions that appear in FDA approval and tentative approval disclosures.

Drug Name Submission class (FDA) Submission Category Submission Date
Libervant ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval 30 Aug, 2022

Aquestive Drug List

Given below is the complete list of Aquestive's drugs and the patents protecting them.


1. Exservan

Exservan is protected by 2 patents, out of which all have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions 03 Apr, 2024
(1 year, 11 months ago)
Expired
US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions 20 Feb, 2024
(2 years ago)
Expired

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Exservan's drug page


2. Libervant

Libervant is protected by 1 patent, which is still active. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11273131 Pharmaceutical compositions with enhanced permeation 18 Jun, 2038
(12 years from now)
Active

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Libervant's drug page


3. Zuplenz

Zuplenz is protected by 2 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US9095577 Stabilized amine-containing actives in oral film compositions 13 Jul, 2030
(4 years from now)
Active
US8580830 Non-mucoadhesive film dosage forms 23 Nov, 2029
(3 years from now)
Active

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Zuplenz's drug page


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Aquestive News

Aquestive Shares Surge in After-Hours Trading as CEO Anticipates $1 Billion 'Blockbuster' Opportunity for Oral Allergy Treatment

26 Sep, 2025

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