Daytrana is a drug owned by Noven Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2017. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2025. Details of Daytrana'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). | |||
| US8632802 | Device for transdermal administration of drugs including acrylic polymers |
Oct, 2025
(4 months from now) | Active |
| US9668981 | Device for transdermal administration of drugs including acrylic based polymers |
Oct, 2025
(4 months from now) | Active |
| US9034370 | Device for transdermal administration of drugs including acrylic polymers |
Oct, 2025
(4 months from now) | Active |
| US6210705 | Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate |
Sep, 2018
(6 years ago) |
Expired
|
| US6348211 | Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate |
Sep, 2018
(6 years ago) |
Expired
|
| US5958446 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec, 2012
(12 years 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 Daytrana's patents.
Latest Legal Activities on Daytrana's Patents
Given below is the list of recent legal activities going on the following patents of Daytrana.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Oct, 2022 | US9034370 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Sep, 2020 | US9668981 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Nov, 2018 | US9034370 |
| Recordation of Patent Grant Mailed Critical | 06 Jun, 2017 | US9668981 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Jun, 2017 | US9668981 |
| Email Notification Critical | 18 May, 2017 | US9668981 |
| Issue Notification Mailed Critical | 17 May, 2017 | US9668981 |
| Dispatch to FDC | 03 May, 2017 | US9668981 |
| Application Is Considered Ready for Issue Critical | 02 May, 2017 | US9668981 |
| Issue Fee Payment Verified Critical | 28 Apr, 2017 | US9668981 |
FDA has granted several exclusivities to Daytrana. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Daytrana, 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 Daytrana.
Exclusivity Information
Daytrana holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Daytrana's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 29, 2013 |
US patents provide insights into the exclusivity only within the United States, but Daytrana 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 Daytrana's family patents as well as insights into ongoing legal events on those patents.
Daytrana's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daytrana's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 07, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Daytrana Generic API suppliers:
Methylphenidate is the generic name for the brand Daytrana. 2 different companies have already filed for the generic of Daytrana, with Mylan Tech Viatris having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Daytrana's generic
How can I launch a generic of Daytrana before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Daytrana's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Daytrana'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 Daytrana -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs | 13 Apr, 2011 | 1 | 30 Sep, 2018 | Extinguished |
Alternative Brands for Daytrana
Daytrana which is used for managing symptoms of attention deficit hyperactivity disorder (ADHD)., 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.
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 |
| |||
| Neos Theraps Inc |
| |||
| Nextwave |
| |||
| Nextwave Pharms |
| |||
| 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, Daytrana's active ingredient. Check the complete list of approved generic manufacturers for Daytrana
About Daytrana
Daytrana is a drug owned by Noven Pharmaceuticals Inc. It is used for managing symptoms of attention deficit hyperactivity disorder (ADHD). Daytrana uses Methylphenidate as an active ingredient. Daytrana was launched by Noven Pharms Inc in 2006.
Approval Date:
Daytrana was approved by FDA for market use on 06 April, 2006.
Active Ingredient:
Daytrana uses Methylphenidate as the active ingredient. Check out other Drugs and Companies using Methylphenidate ingredient
Treatment:
Daytrana is used for managing symptoms of attention deficit hyperactivity disorder (ADHD).
Dosage:
Daytrana is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 15MG/9HR (1.6MG/HR) | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 30MG/9HR (3.3MG/HR) | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 20MG/9HR (2.2MG/HR) | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |