Adderall Xr 15 Patent Expiration

Adderall Xr 15 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 15'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
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
USRE42096 Oral pulsed dose drug delivery system
Oct, 2018

(6 years ago)

Expired
USRE41148 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 15's patents.

Given below is the list of recent legal activities going on the following patents of Adderall Xr 15.

Activity Date Patent Number
Patent litigations
Email Notification 10 Jan, 2017 US6605300
Change in Power of Attorney (May Include Associate POA) 10 Jan, 2017 US6605300
Correspondence Address Change 09 Jan, 2017 US6605300
Correspondence Address Change 23 Jul, 2015 US6605300
Change in Power of Attorney (May Include Associate POA) 23 Jul, 2015 US6605300
Change in Power of Attorney (May Include Associate POA) 01 Mar, 2010 US6605300
Correspondence Address Change 26 Feb, 2010 US6605300
Information Disclosure Statement (IDS) Filed 15 Jan, 2004 US6605300
Reference capture on IDS 15 Jan, 2004 US6605300
Patent Issue Date Used in PTA Calculation 12 Aug, 2003 US6605300

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US patents provide insights into the exclusivity only within the United States, but Adderall Xr 15 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 15's family patents as well as insights into ongoing legal events on those patents.

Adderall Xr 15's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Adderall Xr 15'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 15 Generic API suppliers:

Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate is the generic name for the brand Adderall Xr 15. 30 different companies have already filed for the generic of Adderall Xr 15, 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 15's generic

How can I launch a generic of Adderall Xr 15 before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Adderall Xr 15's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adderall Xr 15'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 15 -

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 15

There are several other brand drugs using the same active ingredient (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) as Adderall Xr 15. 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 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate, Adderall Xr 15's active ingredient. Check the complete list of approved generic manufacturers for Adderall Xr 15





About Adderall Xr 15

Adderall Xr 15 is a drug owned by Takeda Pharmaceuticals Usa Inc. Adderall Xr 15 uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as an active ingredient. Adderall Xr 15 was launched by Takeda Pharms Usa in 2001.

Approval Date:

Adderall Xr 15 was approved by FDA for market use on 11 October, 2001.

Active Ingredient:

Adderall Xr 15 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 15 is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3.75MG;3.75MG;3.75MG;3.75MG CAPSULE, EXTENDED RELEASE Prescription ORAL