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ANDA Litigation Settlements
Fall 2013

Case Name |
Drug |
Patent |
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. |
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