Quillichew Er is a drug owned by Nextwave Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2015 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 14, 2033. Details of Quillichew Er'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). | |||
| US11103495 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US9295642 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US9545399 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US9844544 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US11103494 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US8999386 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US11633389 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US10857143 | Methylphenidate extended release chewable tablet |
Aug, 2033
(8 years from now) | Active |
| US8287903 | Orally effective methylphenidate extended release powder and aqueous suspension product |
Feb, 2031
(5 years from now) | Active |
| US8202537 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2027
(1 year, 10 months 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 Quillichew Er's patents.
Latest Legal Activities on Quillichew Er's Patents
Given below is the list of recent legal activities going on the following patents of Quillichew Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jun, 2024 | US9545399 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 May, 2024 | US10857143 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Apr, 2024 | US8287903 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Dec, 2023 | US8202537 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9295642 |
| Mail Miscellaneous Communication to Applicant | 27 Apr, 2023 | US11633389 |
| Electronic Review Critical | 27 Apr, 2023 | US11633389 |
| Email Notification Critical | 27 Apr, 2023 | US11633389 |
| Miscellaneous Communication to Applicant - No Action Count | 25 Apr, 2023 | US11633389 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Apr, 2023 | US11633389 |
FDA has granted several exclusivities to Quillichew Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Quillichew Er, 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 Quillichew Er.
Exclusivity Information
Quillichew Er holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Quillichew Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 04, 2018 |
US patents provide insights into the exclusivity only within the United States, but Quillichew Er 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 Quillichew Er's family patents as well as insights into ongoing legal events on those patents.
Quillichew Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Quillichew Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 14, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Quillichew Er Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Quillichew Er. 42 different companies have already filed for the generic of Quillichew Er, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Quillichew Er's generic
How can I launch a generic of Quillichew Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Quillichew Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Quillichew Er'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 Quillichew Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 30 mg and 40 mg | 25 Apr, 2016 | 1 | 14 Aug, 2033 |
Alternative Brands for Quillichew Er
Quillichew Er which is used for treating ADHD., 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 |
| |||
| Osmotica Pharm Us |
| |||
| 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, Quillichew Er's active ingredient. Check the complete list of approved generic manufacturers for Quillichew Er
About Quillichew Er
Quillichew Er is a drug owned by Nextwave Pharmaceuticals Inc. It is used for treating ADHD. Quillichew Er uses Methylphenidate Hydrochloride as an active ingredient. Quillichew Er was launched by Nextwave Pharms in 2015.
Approval Date:
Quillichew Er was approved by FDA for market use on 04 December, 2015.
Active Ingredient:
Quillichew Er uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Treatment:
Quillichew Er is used for treating ADHD.
Dosage:
Quillichew Er is available in tablet, extended release, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET, EXTENDED RELEASE, CHEWABLE | Prescription | ORAL |
| 30MG | TABLET, EXTENDED RELEASE, CHEWABLE | Prescription | ORAL |
| 20MG | TABLET, EXTENDED RELEASE, CHEWABLE | Prescription | ORAL |