ANDA Litigation Settlements

Fall 2013

Case Name	Drug	Patent No(s).	Publicly Available Terms
OSI Pharma., Inc. v. Mylan Pharma. Inc., 09-0185 (D. Del.)	Tarceva^®(erlotinib hydrochloride tablets)	RE41,065 6,900,221 7,087,613	N/A
Orion Corp. v. Mylan Pharma. Inc., 12-0523 (D. Del.)	Stalevo^®(carbidopa / levodopa / entacapone)	5,466,194 6,500,867 6,797,732	Mylan to launch authorized generic product immediately upon approval of settlement agreement. Mylan will also launch its generic ANDA product, subject to FDA approval.
Warner Chilcott Co., LLC v. Mylan Inc., 11-3262 (D.N.J.)	Loestrin^®(norethindrone acetate / ethinyl estradiol)	5,552,394	Defendants stipulate to infringement.
Roche Palo Alto LLC v. Lupin Pharma. Inc., 10-3561 (D.N.J.)	Ranexa^®(ranolazine)	6,303,607 6,479,496 6,503,911 6,525,057 6,562,826 6,617,328 6,620,814 6,852,724 6,864,258	N/A
Warner Chilcott Labs. Ireland Ltd. v. Impax Labs. Inc., 08-6304 (D.N.J.)	Doryx^®(doxycycline hyclate)	6,958,161	Warner Chilcott PLC and Mayne Pharma International Pty. Ltd. will pay $12 million to Mylan Inc. and Mylan Pharma. Inc. in full satisfaction of Mylan’s claim under the bond. Mylan’s damages claim will be dismissed and the bond will be released.
Avanir Pharma. Inc. v. Wockhardt Ltd., 11-0758 (D. Del.)	Nuedexta^®(dextromethorphan hydrobromide / quinidine sulfate)	7,659,282 RE38,115	Avanir has signed a licensing agreement with Wockhardt allowing it to launch an authorized generic on July 30, 2026, two weeks before the last patent covering Nuedexta is set to expire.
Merck Sharp & Dohme Corp. v. Sandoz Inc., 12-6077 (D.N.J.)	Zetia^®(ezetimibe)	RE42,461 5,846,966 7,030,106 7,612,058	Sandoz is enjoined until April 25, 2017 from making, using, or selling its generic product. The patents-in-suit expire between 2014 and 2022.
Purdue Pharma LP v. Par Pharma. Cos. Inc., 11-2038 (S.D.N.Y.)	OxyContin^®(oxycodone hydrochloride)	6,488,963 7,674,799 7,674,800 7,683,072 7,776,314	Purdue’s infringement suit was dismissed with prejudice in exchange for Par waiving any possible antitrust or other claim against Purdue arising from conduct or events prior to the date of settlement.