Qelbree is a drug owned by Supernus Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2021 to 2022 out of which none have expired yet. Qelbree's patents will be open to challenges from 02 April, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 07, 2033. Details of Qelbree'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). | |||
| US9662338 | Formulations of viloxazine |
Feb, 2033
(8 years from now) | Active |
| US9603853 | Formulations of viloxazine |
Feb, 2033
(8 years from now) | Active |
| US9358204 | Formulations of viloxazine |
Feb, 2033
(8 years from now) | Active |
| US11324753 | Method of treatment of attention deficit/hyperactivity disorder (ADHD) |
Sep, 2029
(4 years from now) | Active |
| US11458143 | Method of treatment of attention deficit/hyperactivity disorder (ADHD) |
Sep, 2029
(4 years from now) | Active |
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 Qelbree's patents.
Latest Legal Activities on Qelbree's Patents
Given below is the list of recent legal activities going on the following patents of Qelbree.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Dec, 2023 | US9358204 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9358204 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9603853 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9662338 |
| transaction for FDA Determination of Regulatory Review Period | 29 Nov, 2023 | US9603853 |
| Second letter to regulating agency to determine regulatory review period | 21 Oct, 2022 | US9358204 |
| Second letter to regulating agency to determine regulatory review period | 21 Oct, 2022 | US9603853 |
| Second letter to regulating agency to determine regulatory review period | 21 Oct, 2022 | US9662338 |
| Recordation of Patent Grant Mailed Critical | 04 Oct, 2022 | US11458143 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Oct, 2022 | US11458143 |
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 Qelbree and ongoing litigations to help you estimate the early arrival of Qelbree generic.
Qelbree's Litigations
Qelbree been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 16, 2021, against patent number US11324753. The petitioner , challenged the validity of this patent, with Supernus Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Qelbree's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11324753 | February, 2021 |
Decision
(05 Oct, 2021) | Supernus Pharmaceuticals, Inc. | |
FDA has granted some exclusivities to Qelbree. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qelbree, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Qelbree.
Exclusivity Information
Qelbree holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Qelbree's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Apr 29, 2025 |
| New Chemical Entity Exclusivity(NCE) | Apr 02, 2026 |
US patents provide insights into the exclusivity only within the United States, but Qelbree 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 Qelbree's family patents as well as insights into ongoing legal events on those patents.
Qelbree's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qelbree's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 07, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qelbree Generics:
There are no approved generic versions for Qelbree as of now.
Alternative Brands for Qelbree
Qelbree which is used for managing symptoms of ADHD., 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.
About Qelbree
Qelbree is a drug owned by Supernus Pharmaceuticals Inc. It is used for managing symptoms of ADHD. Qelbree uses Viloxazine Hydrochloride as an active ingredient. Qelbree was launched by Supernus Pharms in 2021.
Approval Date:
Qelbree was approved by FDA for market use on 02 April, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Qelbree is 02 April, 2021, its NCE-1 date is estimated to be 02 April, 2025.
Active Ingredient:
Qelbree uses Viloxazine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Viloxazine Hydrochloride ingredient
Treatment:
Qelbree is used for managing symptoms of ADHD.
Dosage:
Qelbree is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 100MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 150MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |