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.
| 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). | |||
| US11541002 | Oral film compositions and dosage forms having precise active dissolution profiles |
Jan, 2040
(15 years from now) | Active |
| 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 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 03 Jan, 2023 | US11541002 |
| Recordation of Patent Grant Mailed Critical | 03 Jan, 2023 | US11541002 |
| Issue Notification Mailed Critical | 14 Dec, 2022 | US11541002 |
| Application Is Considered Ready for Issue Critical | 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 Critical | 27 Oct, 2022 | US11541002 |
| Issue Fee Payment Verified Critical | 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 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 Sympazan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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. |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sympazan's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 31, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sympazan Generic API suppliers:
Clobazam is the generic name for the brand Sympazan. 22 different companies have already filed for the generic of Sympazan, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sympazan's generic
Alternative Brands for Sympazan
Sympazan which is used for managing seizure disorders., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Novartis |
| |||
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.
Approval Date:
Sympazan was approved by FDA for market use on 01 November, 2018.
Active Ingredient:
Sympazan uses Clobazam as the active ingredient. Check out other Drugs and Companies using Clobazam ingredient
Treatment:
Sympazan is used for managing seizure disorders.
Dosage:
Sympazan is available in film form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | FILM | Prescription | ORAL |
| 10MG | FILM | Prescription | ORAL |
| 20MG | FILM | Prescription | ORAL |