ANDA Litigation Settlements

Winter 2013

GENERICally Speaking

Case Name

Drug

Patent
No(s).

Publicly Available Terms

Purdue Pharma LP v. Impax Labs. Inc, 13-0763 (S.D.N.Y.)

OxyContin®(oxycodone hydrochloride extended-release tablets)

8,114,383

8,309,060

Impax agrees not to market or sell its ANDA product and will not challenge the validity of Purdue Pharma’s patents until an unspecified date;

Impax agrees to drop any potential antitrust or other claim against Purdue Pharma.

Hospira Inc. v. Sandoz Inc. (Fed. Cir.)

Precedex®(dexmedetomidine hydrochloride injection)

4,910,214

6,716,867

Sandoz may launch its ANDA product on December 26, 2014, unless certain conditions relating to launch, if triggered, lead to an earlier Sandoz market entry date

Novartis AG v. Accord Healthcare Inc., 13-1013 (D.D.C.)

Myfortic®(mycophenolic acid)

6,025,391

6,172,107

6,306,900

N/A


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