Amophetamine salts (ADDERALL XR) 5, 10, 15, 20, 25 and 30 mg ER Capsules: Shire and Sandoz Settled patent litigation

Innovator Shire, announced (in a press release Here ) that it has settled the pending patent litigation with generic player Sandoz on generic versions of Shire’s ADDERALL XR (mixed amphetamine salts like AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) for the treatment of Attention Deficit Hyperactivity Disorder.

The following patents are listed in Orange Book for this product:

US6322819 (Assignee: Shire Laboratories; Date of Grant: November 27, 2001; Expiry: Apr 21, 2019): which covers a pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising: (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release.

US6605300 (Assignee: Shire Laboratories; Date of Grant: August 12, 2003; Expiry: Apr 21, 2019): A pharmaceutical formulation for delivery of a mixture of amphetamine base salts effective to treat ADHD in a human patient comprising: an immediate release dosage form that provides immediate release upon oral administration to said patient; a delayed enteric release dosage form that provides delayed release upon oral administration to said patient; and a pharmaceutically acceptable carrier; wherein said amphetamine base salts comprise dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate; wherein said pharmaceutical formulation is sufficient to maintain an effective level of amphetamine base salts in the patient over the course of at least 8 hours without further administration of amphetamine base salt, and the peak plasma concentration of amphetamine base salts reached after release of said delayed enteric release dosage form exceeds the peak plasma concentration previously reached after release of said immediate release dosage form; and wherein said pharmaceutical formulation, when containing about a total dose of 20 mg, will produce in a human individual a plasma concentration versus time curve (ng/ml versus hours) having an area under the curve (AUC) of about 467 to about 714 ng hr/ml.


The generic player Sandoz challenged Orange Book patents in 2007, subsequently, innovator sued Sandoz in Colorodo District Court.

As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire’s ’819 and ’300 Patents and that the two patents are valid and enforceable. Also as per press release, resolution of the case against Sandoz ends all pending litigation against generic ANDA applicants over ADDERALL XR. As per press release, the US Federal Trade Commission (FTC) would review the said agreement.


The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR in the United States beginning upon approval of its own generic products by the USFDA and Sandoz will pay Shire a royalty from those sales. Also, no payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remains the only authorized generic supplier of ADDERALL XR.


Earlier, innovator Shire got approval to market this combination product on Oct 11, 2001 (30, 20 and 10 mg Capsules) and on May 22, 2002 (15, 5 and 25 mg capsules)