Focalin Xr is a drug owned by Sandoz Inc. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 01, 2019. Details of Focalin 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). | |||
| US6730325 | Multiparticulate modified release composition |
Nov, 2019
(5 years ago) |
Expired
|
| US6228398 | Multiparticulate modified release composition |
Nov, 2019
(5 years ago) |
Expired
|
| US5837284 | Delivery of multiple doses of medications |
Dec, 2015
(8 years ago) |
Expired
|
| US5908850 | Method of treating attention deficit disorders with d-threo methylphenidate |
Dec, 2015
(8 years ago) |
Expired
|
| US6635284 | Delivery of multiple doses of medications |
Dec, 2015
(8 years ago) |
Expired
|
| US6528530 | Phenidate drug formulations having diminished abuse potential |
Dec, 2015
(8 years ago) |
Expired
|
| US7431944 | Delivery of multiple doses of medications |
Dec, 2015
(8 years ago) |
Expired
|
| US6355656 | Phenidate drug formulations having diminished abuse potential |
Dec, 2015
(8 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 Focalin Xr's patents.
Latest Legal Activities on Focalin Xr's Patents
Given below is the list of recent legal activities going on the following patents of Focalin Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 12 Apr, 2017 | US6730325 (Litigated) |
| File Marked Found | 05 Apr, 2017 | US6730325 (Litigated) |
| Expire Patent Critical | 04 Nov, 2016 | US7431944 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 07 Oct, 2008 | US7431944 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 07 Oct, 2008 | US7431944 (Litigated) |
| Issue Notification Mailed Critical | 17 Sep, 2008 | US7431944 (Litigated) |
| Application Is Considered Ready for Issue Critical | 15 Aug, 2008 | US7431944 (Litigated) |
| Dispatch to FDC | 15 Aug, 2008 | US7431944 (Litigated) |
| Issue Fee Payment Verified Critical | 14 Aug, 2008 | US7431944 (Litigated) |
| Issue Fee Payment Received Critical | 14 Aug, 2008 | US7431944 (Litigated) |
FDA has granted several exclusivities to Focalin Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Focalin 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 Focalin Xr.
Exclusivity Information
Focalin Xr holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Focalin Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-80) | Oct 17, 2011 |
| New Dosing Schedule(D-121) | Oct 23, 2012 |
US patents provide insights into the exclusivity only within the United States, but Focalin 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 Focalin Xr's family patents as well as insights into ongoing legal events on those patents.
Focalin Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Focalin Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Focalin Xr Generic API suppliers:
Dexmethylphenidate Hydrochloride is the generic name for the brand Focalin Xr. 19 different companies have already filed for the generic of Focalin Xr, with Granules having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Focalin Xr's generic
How can I launch a generic of Focalin Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Focalin Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Focalin 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 Focalin Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg | 14 May, 2007 | 1 | 18 Nov, 2013 | 01 Nov, 2019 | Eligible |
| 5 mg, 10 mg and 20 mg | 30 Mar, 2007 | 1 | 19 Nov, 2013 | 01 Nov, 2019 | Eligible |
| 30 mg | 15 Dec, 2010 | 1 | 28 Aug, 2013 | 01 Nov, 2019 | Eligible |
| 40 mg | 20 Dec, 2010 | 1 | 19 Nov, 2013 | 01 Nov, 2019 | Eligible |
| 35 mg | 29 Sep, 2011 | 1 | 30 Nov, 2016 | 01 Nov, 2019 | Eligible |
| 25 mg | 30 Sep, 2011 | 1 | 30 Nov, 2016 | 01 Nov, 2019 | Eligible |
Alternative Brands for Focalin Xr
Focalin Xr which is used for treating attention deficit disorder and/or attention deficit hyperactivity disorder with once daily extended release dosages or bi-modal/pulsatile release compositions., has several other brand drugs using the same active ingredient (Dexmethylphenidate 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexmethylphenidate Hydrochloride, Focalin Xr's active ingredient. Check the complete list of approved generic manufacturers for Focalin Xr
About Focalin Xr
Focalin Xr is a drug owned by Sandoz Inc. It is used for treating attention deficit disorder and/or attention deficit hyperactivity disorder with once daily extended release dosages or bi-modal/pulsatile release compositions. Focalin Xr uses Dexmethylphenidate Hydrochloride as an active ingredient. Focalin Xr was launched by Sandoz in 2005.
Approval Date:
Focalin Xr was approved by FDA for market use on 26 May, 2005.
Active Ingredient:
Focalin Xr uses Dexmethylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dexmethylphenidate Hydrochloride ingredient
Treatment:
Focalin Xr is used for treating attention deficit disorder and/or attention deficit hyperactivity disorder with once daily extended release dosages or bi-modal/pulsatile release compositions.
Dosage:
Focalin Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 15MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 5MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 40MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 35MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 25MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |