Focalin is a drug owned by Sandoz Inc. It is protected by 3 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 Dec 04, 2015. Details of Focalin'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). | |||
| US6355656 | Phenidate drug formulations having diminished abuse potential |
Dec, 2015
(8 years ago) |
Expired
|
| US6528530 | Phenidate drug formulations having diminished abuse potential |
Dec, 2015
(8 years ago) |
Expired
|
| US5908850 | Method of treating attention deficit disorders with d-threo methylphenidate |
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's patents.
Latest Legal Activities on Focalin's Patents
Given below is the list of recent legal activities going on the following patents of Focalin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jun, 2008 | US6528530 (Litigated) |
| Correspondence Address Change Critical | 28 Jun, 2008 | US6528530 (Litigated) |
| Mail-Petition Decision - Granted | 07 Mar, 2008 | US6528530 (Litigated) |
| Petition Decision - Granted Critical | 07 Mar, 2008 | US6528530 (Litigated) |
| Petition Entered | 17 Aug, 2007 | US6528530 (Litigated) |
| Post Issue Communication - Certificate of Correction | 27 Aug, 2004 | US6528530 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 04 Mar, 2003 | US6528530 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 04 Mar, 2003 | US6528530 (Litigated) |
| Issue Notification Mailed Critical | 13 Feb, 2003 | US6528530 (Litigated) |
| Receipt into Pubs | 05 Feb, 2003 | US6528530 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Focalin 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's family patents as well as insights into ongoing legal events on those patents.
Focalin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Focalin's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 04, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Focalin Generic API suppliers:
Dexmethylphenidate Hydrochloride is the generic name for the brand Focalin. 19 different companies have already filed for the generic of Focalin, with Granules having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Focalin's generic
How can I launch a generic of Focalin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Focalin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Focalin'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg | 27 Jul, 2004 | 1 | 29 Jan, 2007 | 04 Dec, 2015 | Eligible |
| 5 mg and 10 mg | 27 May, 2004 | 1 | 29 Jan, 2007 | 04 Dec, 2015 | Eligible |
Alternative Brands for Focalin
Focalin which is used for treating Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder., 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Commave Therap |
| |
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexmethylphenidate Hydrochloride, Focalin's active ingredient. Check the complete list of approved generic manufacturers for Focalin
About Focalin
Focalin is a drug owned by Sandoz Inc. It is used for treating Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Focalin uses Dexmethylphenidate Hydrochloride as an active ingredient. Focalin was launched by Sandoz in 2001.
Approval Date:
Focalin was approved by FDA for market use on 13 November, 2001.
Active Ingredient:
Focalin uses Dexmethylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dexmethylphenidate Hydrochloride ingredient
Treatment:
Focalin is used for treating Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder.
Dosage:
Focalin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |