Adderall Xr 5 is a drug owned by Takeda Pharmaceuticals Usa 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 Apr 21, 2019. Details of Adderall Xr 5'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). | |||
|
USRE41148 (Pediatric) | Oral pulsed dose drug delivery system |
Apr, 2019
(5 years ago) |
Expired
|
|
US6605300 (Pediatric) | Oral pulsed dose drug delivery system |
Apr, 2019
(5 years ago) |
Expired
|
|
US6322819 (Pediatric) | Oral pulsed dose drug delivery system |
Apr, 2019
(5 years ago) |
Expired
|
|
USRE42096 (Pediatric) | Oral pulsed dose drug delivery system |
Apr, 2019
(5 years ago) |
Expired
|
| USRE41148 | Oral pulsed dose drug delivery system |
Oct, 2018
(6 years ago) |
Expired
|
| USRE42096 | Oral pulsed dose drug delivery system |
Oct, 2018
(6 years ago) |
Expired
|
| US6322819 | Oral pulsed dose drug delivery system |
Oct, 2018
(6 years ago) |
Expired
|
| US6605300 | Oral pulsed dose drug delivery system |
Oct, 2018
(6 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 Adderall Xr 5's patents.
Latest Legal Activities on Adderall Xr 5's Patents
Given below is the list of recent legal activities going on the following patents of Adderall Xr 5.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 10 Jan, 2017 | US6605300 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Jan, 2017 | US6605300 |
| Correspondence Address Change Critical | 09 Jan, 2017 | US6605300 |
| Correspondence Address Change Critical | 23 Jul, 2015 | US6605300 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 Jul, 2015 | US6605300 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Mar, 2010 | US6605300 |
| Correspondence Address Change Critical | 26 Feb, 2010 | US6605300 |
| Information Disclosure Statement (IDS) Filed Critical | 15 Jan, 2004 | US6605300 |
| Reference capture on IDS | 15 Jan, 2004 | US6605300 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Aug, 2003 | US6605300 |
US patents provide insights into the exclusivity only within the United States, but Adderall Xr 5 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 Adderall Xr 5's family patents as well as insights into ongoing legal events on those patents.
Adderall Xr 5's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Adderall Xr 5's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 21, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adderall Xr 5 Generic API suppliers:
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate is the generic name for the brand Adderall Xr 5. 29 different companies have already filed for the generic of Adderall Xr 5, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Adderall Xr 5's generic
How can I launch a generic of Adderall Xr 5 before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adderall Xr 5's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adderall Xr 5'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 Adderall Xr 5 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg |
Alternative Brands for Adderall Xr 5
There are several other brand drugs using the same active ingredient (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) as Adderall Xr 5. 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate, Adderall Xr 5's active ingredient. Check the complete list of approved generic manufacturers for Adderall Xr 5
About Adderall Xr 5
Adderall Xr 5 is a drug owned by Takeda Pharmaceuticals Usa Inc. Adderall Xr 5 uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as an active ingredient. Adderall Xr 5 was launched by Takeda Pharms Usa in 2001.
Approval Date:
Adderall Xr 5 was approved by FDA for market use on 11 October, 2001.
Active Ingredient:
Adderall Xr 5 uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as the active ingredient. Check out other Drugs and Companies using Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ingredient
Dosage:
Adderall Xr 5 is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |