Otter Pharms Drug Patent Portfolio

Otter Pharms owns 2 orange book drugs protected by 22 US patents Given below is the list of Otter Pharms'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
US8814834 Injector safety device 27 May, 2031
Active
US11497753 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
US8021335 Prefilled syringe jet injector 04 Oct, 2026
Active
US11446441 Prefilled syringe injector 24 Jan, 2026
Active
US8562564 Prefilled syringe jet injector 24 Jan, 2026
Active
US9533102 Prefilled syringe jet injector 24 Jan, 2026
Active
US9629959 Prefilled syringe jet injector 24 Jan, 2026
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
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


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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 01 Jul, 2024 US9533102
Payment of Maintenance Fee, 8th Year, Large Entity 23 Feb, 2024 US9421333
Payment of Maintenance Fee, 4th Year, Large Entity 11 Jan, 2024 US10709844
Patent eGrant Notification 27 Jun, 2023 US11684723
Mail Patent eGrant Notification 27 Jun, 2023 US11684723
Recordation of Patent eGrant 27 Jun, 2023 US11684723
Email Notification 27 Jun, 2023 US11684723
Patent Issue Date Used in PTA Calculation 27 Jun, 2023 US11684723
Electronic Review 27 Jun, 2023 US11684723
Recordation of Patent Grant Mailed 27 Jun, 2023 US11684723
Electronic Review 08 Jun, 2023 US11684723
Email Notification 08 Jun, 2023 US11684723
Issue Notification Mailed 07 Jun, 2023 US11684723
Electronic Review 17 May, 2023 US11684723
Application Is Considered Ready for Issue 11 May, 2023 US11684723


Otter Pharms's Drug Patent Litigations

Otter Pharms'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. as the respondent. Click below to track the latest information on how companies are challenging Otter Pharms's patents.

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.


Otter Pharms Drug Patents' Oppositions Filed in EPO

Otter Pharms 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


Otter Pharms's Family Patents

Otter Pharms drugs have patent protection in a total of 21 countries. It's US patent count contributes only to 49.2% 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



Otter Pharms Drug List

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


1. Otrexup

Otrexup is protected by 19 patents, out of which 5 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
(6 years from now)
Active
US11497753 Hazardous agent injection system 19 Mar, 2030
(5 years from now)
Active
US8480631 Hazardous agent injection system 19 Mar, 2030
(5 years from now)
Active
US8579865 Hazardous agent injection system 19 Mar, 2030
(5 years from now)
Active
US8945063 Hazardous agent injection system 19 Mar, 2030
(5 years from now)
Active
US9421333 Hazardous agent injection system 19 Mar, 2030
(5 years from now)
Active
US10709844 Injector safety device 10 Mar, 2029
(4 years from now)
Active
US11684723 Injector safety device 10 Mar, 2029
(4 years from now)
Active
US9867949 Injector safety device 10 Mar, 2029
(4 years from now)
Active
US8021335 Prefilled syringe jet injector 04 Oct, 2026
(1 year, 9 months from now)
Active
US11446441 Prefilled syringe injector 24 Jan, 2026
(1 year, 24 days from now)
Active
US8562564 Prefilled syringe jet injector 24 Jan, 2026
(1 year, 24 days from now)
Active
US9533102 Prefilled syringe jet injector 24 Jan, 2026
(1 year, 24 days from now)
Active
US9629959 Prefilled syringe jet injector 24 Jan, 2026
(1 year, 24 days from now)
Active
US6746429 Needle assisted jet injector 12 Apr, 2020
(4 years ago)
Expired
US7744582 Needle assisted jet injector 10 Aug, 2019
(5 years ago)
Expired
US7776015 Needle assisted jet injector 10 Aug, 2019
(5 years ago)
Expired
USRE44846 Needle assisted jet injector 10 Aug, 2019
(5 years ago)
Expired
USRE44847 Needle assisted jet injector 10 Aug, 2019
(5 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


2. Sympazan

Sympazan is protected by 3 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
(15 years from now)
Active
US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions 03 Apr, 2024
(8 months ago)
Expired
US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions 20 Feb, 2024
(10 months 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


Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List