Sympazan is a drug owned by Otter Pharmaceuticals Llc. It is protected by 3 US drug patents filed from 2018 to 2022. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 31, 2040. Details of Sympazan's patents and their expiration are given in the table below.

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 Sympazan's patents.

Latest Legal Activities on Sympazan's Patents

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

Event	Date	Patent/Publication
Critical Events This Week
Patent Issue Date Used in PTA Calculation	03 Jan, 2023	US11541002
Recordation of Patent Grant Mailed	03 Jan, 2023	US11541002
Issue Notification Mailed	14 Dec, 2022	US11541002
Application Is Considered Ready for Issue	29 Nov, 2022	US11541002
Dispatch to FDC	29 Nov, 2022	US11541002
Workflow - Drawings Finished	28 Nov, 2022	US11541002
PUB Other miscellaneous communication to applicant	03 Nov, 2022	US11541002
Mail PUB other miscellaneous communication to applicant	03 Nov, 2022	US11541002
Issue Fee Payment Received	27 Oct, 2022	US11541002
Issue Fee Payment Verified	27 Oct, 2022	US11541002

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 Sympazan and ongoing litigations to help you estimate the early arrival of Sympazan generic.

Sympazan's Litigations

Sympazan has 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 or infringement of this patent, with MonoSol Rx, LLC. as the respondent. Click below to track the latest information on how companies are challenging Sympazan's patents.

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
Live updates
US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy’s Laboratories, Inc.
US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Par Pharmaceutical, Inc.
US8603514	November, 2016	Terminated-Adverse Judgment	MonoSol Rx, LLC	Mylan Technologies, Inc.
US8603514	May, 2016	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy's Laboratories, Inc.
US8603514	December, 2015	Terminated-Denied	MONOSOL RX LLC	Teva Pharmaceuticals USA Inc
US8765167	October, 2014	FWD Entered	MonoSol Rx, LLC.	BioDelivery Sciences International, Inc.
US8765167	October, 2014	Terminated-Denied	MonoSol Rx, LLC.	BioDelivery Sciences International, Inc.

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Several oppositions have been filed on Sympazan'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 Sympazan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sympazan patents.

Sympazan's oppositions filed in EPO

Sympazan 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
Live updates
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 Sympazan 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 Sympazan's family patents as well as insights into ongoing legal events on those patents.

Sympazan's family patents

Sympazan has patent protection in a total of 19 countries. It's US patent count contributes only to 48.4% 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 Sympazan.

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About Sympazan

Sympazan is a drug owned by Otter Pharmaceuticals Llc. It is used for managing seizure disorders. Sympazan uses Clobazam as an active ingredient. Sympazan was launched by Otter Pharms in 2018.