Quillivant Xr is a drug owned by Nextwave Pharmaceuticals Inc A Sub Of Tris Pharma Inc. It is protected by 7 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2031. Details of Quillivant Xr'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). | |||
| US8563033 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US8778390 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US8956649 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US8465765 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US9040083 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US8287903 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(6 years from now) | Active |
| US8062667 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 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 Quillivant Xr's patents.
Latest Legal Activities on Quillivant Xr's Patents
Given below is the list of recent legal activities going on the following patents of Quillivant Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Apr, 2024 | US8287903 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2022 | US9040083 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Dec, 2021 | US8778390 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Apr, 2021 | US8563033 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Oct, 2020 | US8465765 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Apr, 2020 | US8287903 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Nov, 2018 | US9040083 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jan, 2018 | US8778390 (Litigated) |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US9040083 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US8563033 (Litigated) |
FDA has granted several exclusivities to Quillivant Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Quillivant Xr, 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 Quillivant Xr.
Exclusivity Information
Quillivant Xr holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Quillivant Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Sep 27, 2015 |
US patents provide insights into the exclusivity only within the United States, but Quillivant Xr 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 Quillivant Xr's family patents as well as insights into ongoing legal events on those patents.
Quillivant Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Quillivant Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 15, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Quillivant Xr Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Quillivant Xr. 42 different companies have already filed for the generic of Quillivant Xr, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Quillivant Xr's generic
How can I launch a generic of Quillivant Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Quillivant Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Quillivant Xr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Quillivant Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/mL | 02 Aug, 2013 |
Alternative Brands for Quillivant Xr
Quillivant Xr which is used for treating attention deficit hyperactivity disorder (ADHD) and other conditions susceptible to treatment with methylphenidate., has several other brand drugs using the same active ingredient (Methylphenidate Hydrochloride). 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 | |||
|---|---|---|---|---|
| Aytu Biopharma |
| |||
| Commave Therap |
| |||
| Ironshore Pharms |
| |||
| Janssen Pharms |
| |||
| Nextwave Pharms |
| |||
| Purdue Pharma Lp |
| |||
| Rhodes Pharms |
| |||
| Sandoz |
| |||
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Methylphenidate Hydrochloride, Quillivant Xr's active ingredient. Check the complete list of approved generic manufacturers for Quillivant Xr
About Quillivant Xr
Quillivant Xr is a drug owned by Nextwave Pharmaceuticals Inc A Sub Of Tris Pharma Inc. It is used for treating attention deficit hyperactivity disorder (ADHD) and other conditions susceptible to treatment with methylphenidate. Quillivant Xr uses Methylphenidate Hydrochloride as an active ingredient. Quillivant Xr was launched by Nextwave in 2012.
Approval Date:
Quillivant Xr was approved by FDA for market use on 27 September, 2012.
Active Ingredient:
Quillivant Xr uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Treatment:
Quillivant Xr is used for treating attention deficit hyperactivity disorder (ADHD) and other conditions susceptible to treatment with methylphenidate.
Dosage:
Quillivant Xr is available in for suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |