Assertio Speclty Drug Patent Portfolio

Assertio Speclty owns 4 orange book drugs protected by 39 US patents Given below is the list of Assertio Speclty's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11541002 Oral film compositions and dosage forms having precise active dissolution profiles 31 Jan, 2040
Active
US12290597 Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles 05 Sep, 2039
Active
US12403090 Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles 05 Sep, 2039
Active
US8814834 Injector safety device 27 May, 2031
Active
US11497753 Hazardous agent injection system 19 Mar, 2030
Active
US12357642 Hazardous Agent Injection System 19 Mar, 2030
Active
US8480631 Hazardous agent injection system 19 Mar, 2030
Active
US8579865 Hazardous agent injection system 19 Mar, 2030
Active
US8945063 Hazardous agent injection system 19 Mar, 2030
Active
US9421333 Hazardous agent injection system 19 Mar, 2030
Active
US10709844 Injector safety device 10 Mar, 2029
Active
US11684723 Injector safety device 10 Mar, 2029
Active
US9867949 Injector safety device 10 Mar, 2029
Active
US7662858 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US7884095 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US7939518 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US8110606 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US8623920 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US9561200 Method of treating post-surgical acute pain 24 Feb, 2029
Active
US8021335 Prefilled syringe jet injector 04 Oct, 2026
Active
US7759394 Diclofenac formulations and methods of use 16 Jun, 2026
Active
US8097651 Diclofenac formulations and methods of use 16 Jun, 2026
Active
US8927604 Diclofenac formulations and methods of use 16 Jun, 2026
Active
US9827197 Diclofenac formulations and methods of use 16 Jun, 2026
Active
US11446441 Prefilled syringe injector 24 Jan, 2026 Expired
US8562564 Prefilled syringe jet injector 24 Jan, 2026 Expired
US9533102 Prefilled syringe jet injector 24 Jan, 2026 Expired
US9629959 Prefilled syringe jet injector 24 Jan, 2026 Expired
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
US6746429 Needle assisted jet injector 12 Apr, 2020 Expired
US7744582 Needle assisted jet injector 10 Aug, 2019 Expired
US7776015 Needle assisted jet injector 10 Aug, 2019 Expired
USRE44846 Needle assisted jet injector 10 Aug, 2019 Expired
USRE44847 Needle assisted jet injector 10 Aug, 2019 Expired
US6365180 Oral liquid compositions 15 Jul, 2019 Expired
US6287594 Oral liquid compositions 15 Jan, 2019 Expired
US6974595 Pharmaceutical compositions based on Diclofenae 15 May, 2017 Expired
US7482377 Pharmaceutical compositions and methods of treatment based on diclofenac 15 May, 2017 Expired


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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 09 Sep, 2025 US12403090
Recordation of Patent eGrant 02 Sep, 2025 US12403090
Patent eGrant Notification 02 Sep, 2025 US12403090
Patent Issue Date Used in PTA Calculation 02 Sep, 2025 US12403090
Mail Patent eGrant Notification 02 Sep, 2025 US12403090
Issue Notification Mailed 20 Aug, 2025 US12403090
Maintenance Fee Reminder Mailed 28 Jul, 2025 US8603514 (Litigated)
Application Is Considered Ready for Issue 25 Jul, 2025 US12403090
Dispatch to FDC 25 Jul, 2025 US12403090
Mail Response to 312 Amendment (PTO-271) 23 Jul, 2025 US12403090
Response to Amendment under Rule 312 22 Jul, 2025 US12403090
Recordation of Patent Grant Mailed 22 Jul, 2025 US12357642
Email Notification 16 Jul, 2025 US12357642
Patent eGrant Notification 15 Jul, 2025 US12357642
Mail Patent eGrant Notification 15 Jul, 2025 US12357642


Assertio Speclty's Drug Patent Litigations

Assertio Speclty'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 Assertio Speclty'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.


Assertio Speclty Drug Patents' Oppositions Filed in EPO

Assertio Speclty 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
EP19150366A Sep, 2022 Bandpay & Greuter Granted and Under Opposition
EP06719329A Oct, 2019 Bandpay & Greuter Patent maintained as amended
EP09719763A Jun, 2016 Ypsomed AG Revoked
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


Assertio Speclty's Family Patents

Assertio Speclty drugs have patent protection in a total of 30 countries. It's US patent count contributes only to 47.4% of its total global patent coverage. 6 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



Assertio Speclty Drug List

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


1. Cambia

Cambia is protected by 6 patents, out of which 2 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7759394 Diclofenac formulations and methods of use 16 Jun, 2026
(2 months from now)
Active
US8097651 Diclofenac formulations and methods of use 16 Jun, 2026
(2 months from now)
Active
US8927604 Diclofenac formulations and methods of use 16 Jun, 2026
(2 months from now)
Active
US9827197 Diclofenac formulations and methods of use 16 Jun, 2026
(2 months from now)
Active
US6974595 Pharmaceutical compositions based on Diclofenae 15 May, 2017
(8 years ago)
Expired
US7482377 Pharmaceutical compositions and methods of treatment based on diclofenac 15 May, 2017
(8 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 Cambia's drug page


2. Otrexup

Otrexup is protected by 20 patents, out of which 9 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8814834 Injector safety device 27 May, 2031
(5 years from now)
Active
US11497753 Hazardous agent injection system 19 Mar, 2030
(3 years from now)
Active
US12357642 Hazardous Agent Injection System 19 Mar, 2030
(3 years from now)
Active
US8480631 Hazardous agent injection system 19 Mar, 2030
(3 years from now)
Active
US8579865 Hazardous agent injection system 19 Mar, 2030
(3 years from now)
Active
US8945063 Hazardous agent injection system 19 Mar, 2030
(3 years from now)
Active
US9421333 Hazardous agent injection system 19 Mar, 2030
(3 years from now)
Active
US10709844 Injector safety device 10 Mar, 2029
(2 years from now)
Active
US11684723 Injector safety device 10 Mar, 2029
(2 years from now)
Active
US9867949 Injector safety device 10 Mar, 2029
(2 years from now)
Active
US8021335 Prefilled syringe jet injector 04 Oct, 2026
(6 months from now)
Active
US11446441 Prefilled syringe injector 24 Jan, 2026
(a month ago)
Expired
US8562564 Prefilled syringe jet injector 24 Jan, 2026
(a month ago)
Expired
US9533102 Prefilled syringe jet injector 24 Jan, 2026
(a month ago)
Expired
US9629959 Prefilled syringe jet injector 24 Jan, 2026
(a month ago)
Expired
US6746429 Needle assisted jet injector 12 Apr, 2020
(5 years ago)
Expired
US7744582 Needle assisted jet injector 10 Aug, 2019
(6 years ago)
Expired
US7776015 Needle assisted jet injector 10 Aug, 2019
(6 years ago)
Expired
USRE44846 Needle assisted jet injector 10 Aug, 2019
(6 years ago)
Expired
USRE44847 Needle assisted jet injector 10 Aug, 2019
(6 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 Otrexup's drug page


3. Sympazan

Sympazan is protected by 5 patents, out of which 2 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11541002 Oral film compositions and dosage forms having precise active dissolution profiles 31 Jan, 2040
(13 years from now)
Active
US12290597 Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles 05 Sep, 2039
(13 years from now)
Active
US12403090 Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles 05 Sep, 2039
(13 years from now)
Active
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 Sympazan's drug page


4. Zipsor

Zipsor is protected by 8 patents, out of which 2 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7662858 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US7884095 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US7939518 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US8110606 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US8623920 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US9561200 Method of treating post-surgical acute pain 24 Feb, 2029
(2 years from now)
Active
US6365180 Oral liquid compositions 15 Jul, 2019
(6 years ago)
Expired
US6287594 Oral liquid compositions 15 Jan, 2019
(7 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 Zipsor's drug page


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