Cotempla Xr-odt is a drug owned by Neos Therapeutics Inc. It is protected by 4 US drug patents filed from 2017 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2038. Details of Cotempla Xr-odt'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). | |||
| US11166947 | Effective dosing of a child for the treatment of ADHD with methylphenidate |
Jan, 2038
(13 years from now) | Active |
| US9089496 | Compositions comprising methylphenidate complexed with ion-exchange resin particles |
Jun, 2032
(7 years from now) | Active |
| US9072680 | Compositions comprising methylphenidate complexed with ion-exchange resin particles |
Jun, 2032
(7 years from now) | Active |
| US8840924 | Compositions and methods of making rapidly dissolving ionically masked formulations |
Jun, 2026
(1 year, 5 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 Cotempla Xr-odt's patents.
Latest Legal Activities on Cotempla Xr-odt's Patents
Given below is the list of recent legal activities going on the following patents of Cotempla Xr-odt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 29 Dec, 2022 | US9072680 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Nov, 2021 | US11166947 |
| Recordation of Patent Grant Mailed Critical | 09 Nov, 2021 | US11166947 |
| Email Notification Critical | 21 Oct, 2021 | US11166947 |
| Issue Notification Mailed Critical | 20 Oct, 2021 | US11166947 |
| Dispatch to FDC | 13 Oct, 2021 | US11166947 |
| Application Is Considered Ready for Issue Critical | 13 Oct, 2021 | US11166947 |
| Printer Rush- No mailing | 13 Oct, 2021 | US11166947 |
| Miscellaneous Incoming Letter | 01 Oct, 2021 | US11166947 |
| Mail PUB other miscellaneous communication to applicant | 22 Sep, 2021 | US11166947 |
FDA has granted several exclusivities to Cotempla Xr-odt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cotempla Xr-odt, 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 Cotempla Xr-odt.
Exclusivity Information
Cotempla Xr-odt holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Cotempla Xr-odt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 19, 2020 |
US patents provide insights into the exclusivity only within the United States, but Cotempla Xr-odt 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 Cotempla Xr-odt's family patents as well as insights into ongoing legal events on those patents.
Cotempla Xr-odt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cotempla Xr-odt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cotempla Xr-odt Generic API suppliers:
Methylphenidate is the generic name for the brand Cotempla Xr-odt. 2 different companies have already filed for the generic of Cotempla Xr-odt, with Mylan Tech Viatris having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cotempla Xr-odt's generic
How can I launch a generic of Cotempla Xr-odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cotempla Xr-odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cotempla Xr-odt'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 Cotempla Xr-odt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8.6 mg, 17.3 mg and 25.9 mg | 01 Sep, 2017 | 1 | 19 Jun, 2020 | 28 Jun, 2032 | Eligible |
Alternative Brands for Cotempla Xr-odt
Cotempla Xr-odt which is used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients., has several other brand drugs in the same treatment category and using the same active ingredient (Methylphenidate). 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 | ||
|---|---|---|---|---|
| Azurity |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Methylphenidate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Aytu Biopharma |
| |||
| Commave Therap |
| |||
| Ironshore Pharms |
| |||
| Janssen Pharms |
| |||
| Nextwave |
| |||
| Nextwave Pharms |
| |||
| Noven Pharms Inc |
| |||
| Purdue Pharma Lp |
| |||
| Rhodes Pharms |
| |||
| Sandoz |
| |||
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Methylphenidate, Cotempla Xr-odt's active ingredient. Check the complete list of approved generic manufacturers for Cotempla Xr-odt
About Cotempla Xr-odt
Cotempla Xr-Odt is a drug owned by Neos Therapeutics Inc. It is used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients. Cotempla Xr-Odt uses Methylphenidate as an active ingredient. Cotempla Xr-Odt was launched by Neos Theraps Inc in 2017.
Approval Date:
Cotempla Xr-odt was approved by FDA for market use on 19 June, 2017.
Active Ingredient:
Cotempla Xr-odt uses Methylphenidate as the active ingredient. Check out other Drugs and Companies using Methylphenidate ingredient
Treatment:
Cotempla Xr-odt is used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients.
Dosage:
Cotempla Xr-odt is available in tablet, orally disintegrating, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |