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New ANDA Cases
Winter 2012

Case Name |
Date Filed |
Judge |
Drug |
Patent No(s). |
Avanir Pharma., Inc. v. Impax Labs., Inc., 12-1298 (D. Del.) |
Oct. 8, 2012 |
Hon. Leonard P. Stark |
Nuedexta®(dextromethorphan hydrobromide / quinidine sulfate capsules) |
8,227,484 |
Purdue Pharma L.P. v. Sandoz Inc., 12-7582 (S.D.N.Y.) |
Oct. 10, 2012 |
Hon. Sidney H. Stein |
OxyContin®(oxycodone hydrochloride extended-release tablets) |
8,114,383 |
Gilead Sciences, Inc. v. Lupin Ltd., 12-7910 (S.D.N.Y.) |
Oct. 24, 2012 |
Hon. Richard J. Sullivan |
Viread®(tenofovir disoproxil fumarate tablets) |
5,922,695 5,935,946 5,977,089 6,043,230 |
Purdue Pharma. Products L.P. v. Par Pharma., Inc., 12-6738 (D.N.J.) |
Oct. 25, 2012 |
Hon. Jose L. Linares |
Intermezzo®(zolpidem tartrate sublingual tablets) |
8,242,131 8,252,809 |
Purdue Pharma. Products L.P. v. Par Formulations Private Ltd., 12-6741 (D.N.J.) |
Oct. 25, 2012 |
Hon. Jose L. Linares |
Intermezzo®(zolpidem tartrate sublingual tablets) |
8,242,131 8,252,809 |
Mallinckrodt Inc. v. Watson Labs., Inc.-Florda, 12-6744 (D.N.J.) |
Oct. 25, 2012 |
Hon. William J. Martini |
Exalgo®(hydromorphone hydrochloride extended-release tablets) |
5,914,131 |
Jazz Pharma., Inc. v. Roxane Labs., Inc., 12-6761 (D.N.J.) |
Oct. 26, 2012 |
Hon. Esther Salas |
Xyrem®(sodium oxybate oral solution) |
8,263,650 |
Acura Pharma., Inc. v. Impax Labs., Inc., 12-1371 (D. Del.) |
Oct. 31, 2012 |
Hon. Richard G. Andrews |
Oxecta®(oxycodone hydrochloride tablets) |
7,510,726 |
Acura Pharma., Inc. v. Par Pharma., Inc., 12-1372 (D. Del.) |
Oct. 31, 2012 |
Hon. Richard G. Andrews |
Oxecta®(oxycodone hydrochloride tablets) |
7,510,726 |
Acura Pharma., Inc. v. Sandoz Inc., 12-1373 (D. Del.) |
Oct. 31, 2012 |
Hon. Richard G. Andrews |
Oxecta®(oxycodone hydrochloride tablets) |
7,510,726 |
Acura Pharma., Inc. v. Watson Labs., Inc.-Florda, 12-1374 (D. Del.) |
Oct. 31, 2012 |
Hon. Richard G. Andrews |
Oxecta®(oxycodone hydrochloride tablets) |
7,510,726 |
Acura Pharma., Inc. v. Sandoz, Inc., 12-6784 (S.D.N.Y.) |
Nov. 1, 2012 |
Hon. Michael A. Shipp |
Oxecta®(oxycodone hydrochloride tablets) |
7,510,726 |
AstraZeneca Pharma. LP v. Lupin Ltd., 12-6888 (D.N.J.) |
Nov. 5, 2012 |
Hon. Joel A. Pisano |
Seroquel XR®(quetiapine fumarate extended-release tablets) |
5,948,437 |
Endo Pharma. Inc. v. Teva Pharma. USA, Inc., 12-8060 (S.D.N.Y.) |
Nov. 5, 2012 |
Hon. George B. Daniels |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,075,872 8,114,383 8,192,722 8,309,060 8,309,122 |
Endo Pharma. Inc. v. Amneal Pharma., LLC, 12-8115 (S.D.N.Y.) |
Nov. 7, 2012 |
Hon. Andrew L. Carter, Jr. |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,075,872 8,114,383 8,192,722 8,309,060 8,309,122 |
AbbVie Inc. v. Watson Pharma., Inc., 12-1409 (D. Del.) |
Nov. 8, 2012 |
Hon. Sue L. Robinson |
Niaspan®(niacin extended-release tablets) |
6,080,428 6,469,035 |
Merck Sharp & Dohme Corp. v. APP Pharma., Inc., 12-1410 (D. Del.) |
Nov. 9, 2012 |
Hon. Richard G. Andrews |
Integrilin®(eptifibatide injection) |
5,807,825 5,747,447 5,968,902 |
Ferring B.V. v. Watson Pharma., Inc., 12-1935 (D. Nev.) |
Nov. 9, 2012 |
Hon. Miranda M. Du |
Lysteda®(tranexamic acid tablets) |
8,273,795 |
Ferring B.V. v. Apotex Inc., 12-1941 (D. Nev.) |
Nov. 9, 2012 |
Hon. Gloria M. Navarro |
Lysteda®(tranexamic acid tablets) |
8,273,795 |
Endo Pharma. Inc. v. Impax Labs., Inc., 12-8317 (S.D.N.Y.) |
Nov. 14, 2012 |
Hon. P. Kevin Castel |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,075,872 8,114,383 8,192,722 8,309,060 8,309,122 |
Endo Pharma. Inc. v. Sandoz, Inc., 12-8318 (S.D.N.Y.) |
Nov. 14, 2012 |
JudgeP. Kevin Castel |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,075,872 8,114,383 8,192,722 8,309,060 8,309,122 |
Astellas US LLC v. Akorn, Inc., 12-1489 (D. Del.) |
Nov. 19, 2012 |
Hon. Sue L. Robinson |
Adenoscan®(adenosine injection) |
5,731,296 |
Millenium Pharma., Inc. v. Accord Healthcare, Inc., 12-1490 (D. Del.) |
Nov. 19, 2012 |
Hon. Gregory M. Sleet |
Velcade®(bortezomib injection) |
6,713,446 6,958,319 |
Apotex, Inc. v. Daiichi Sankyo, Inc., 12-9295 (N.D. Ill.) |
Nov. 20, 2012 |
Hon. Sharon Johnson Coleman |
Benicar®(olmesartan medoxomil tablets) |
6,878,703 |
Bayer Pharma AG v. Lupin Ltd., 12-1592 (D. Del.) |
Nov. 28, 2012 |
Hon. Christopher J. Burke |
Natazia®(estradiol valerate / dinogest tablets) |
8,071,577 |
Takeda Pharma. Co., Ltd. v. Lupin Ltd., 12-7333 (D.N.J.) |
Nov. 29, 2012 |
Hon. Joel A. Pisano |
Prevacid®SoluTab™ (lansoprazole delayed-release orally disintegrating tablets) |
6,328,994 7,431,942 7,399,485 7,875,292 |
Bayer Pharma AG v. Lupin Ltd., 12-3526 (D. Md.) |
Nov. 29, 2012 |
Hon. William D. Quarles, Jr. |
Natazia®(estradiol valerate / dinogest tablets) |
8,071,577 |
Medicis Pharma. Corp. v. Alkem Labs. Ltd., 12-1663 (D. Del.) |
Dec. 5, 2012 |
Hon. Leonard P. Stark |
Solodyn®(minocycline hydrochloride extended-release tablets) |
5,908,838 7,790,705 8,268,804 |
Medicis Pharma. Corp. v. Sidmak Labs. (Indai) Pvt. Ltd., 12-1664 (D. Del.) |
Dec. 5, 2012 |
Hon. Leonard P. Stark |
Solodyn®(minocycline hydrochloride extended-release tablets) |
5,908,838 7,790,705 8,268,804 |
Jazz Pharma., Inc. v. Roxane Labs., Inc., 12-7459 (D.N.J.) |
Dec. 5, 2012 |
Hon. Esther Salas |
Xyrem®(sodium oxybate oral solution) |
8,324,275 |
Glycobiosciences, Inc. v. Anika Therapeutics, Inc., 12-1963 (D.D.C.) |
Dec. 6, 2012 |
Hon. Rosemary M. Collyer |
Hyalofill®(hyaluronic acid ester) |
6,120,804 6,723,345 |
Medicis Pharma. Corp. v. Alkem Labs. Ltd., 12-7493 (D.N.J.) |
Dec. 6, 2012 |
Hon. Michael A. Shipp |
Solodyn®(minocycline hydrochloride extended-release tablets) |
5,908,838 7,790,705 8,268,804 |
Osi Pharma., LLC v. Roxane Labs., Inc., 12-1669 (D. Del.) |
Dec. 7, 2012 |
Hon. Sue L. Robinson |
Tarceva®(erlotinib hydrochloride tablets) |
RE41,065 6,900,221 7,087,613 |
Alkermes Pharma Ireland Ltd. v. Mylan Pharma. Inc., 12-1673 (D. Del.) |
Dec. 7, 2012 |
Hon. Sue L. Robinson |
Focalin®XR (dexmethylphenidate hydrochloride extended-release capsules) |
6,228,398 6,730,325 |
Celgene Corp. v. Mylan Pharma. Inc., 12-7590 (D.N.J.) |
Dec. 7, 2012 |
Hon. Susan D. Wigenton |
Focalin XR®(dexmethylphenidate hydrochloride extended-release capsules) |
5,908,850 6,355,656 6,528,530 5,837,284 6,635,284 7,431,944 |
Endo Pharma. Inc. v. Actavis Inc., 12-8985 (S.D.N.Y.) |
Dec. 11, 2012 |
JudgeThomas P. Griesa |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,309,122 8,329,216 |
Astellas US LLC v. Fresenius Kabi USA, LLC, 12-1699 (D. Del.) |
Dec. 12, 2012 |
Hon. Sue L. Robinson |
Adenoscan®(adenosine injection) |
5,731,296 |
Merz Pharma., LLC v. Par Pharma., Inc., 12-1723 (D. Del.) |
Dec. 17, 2012 |
Hon. Sue L. Robinson |
Cuvposa®(glycopyrrolate oral solution) |
7,638,552 7,816,396 |
Bayer Pharma AG v. Watson Pharma., Inc., 12-1726 (D. Del.) |
Dec. 18, 2012 |
Hon. Christopher J. Burke |
Natazia®(estradiol valerate / dinogest tablets) |
8,071,577 |
Endo Pharma. Inc. v. Par Pharma. Cos., Inc., 12-9261 (S.D.N.Y.) |
Dec. 19, 2012 |
JudgeThomas P. Griesa |
Opana®ER (oxymorphone hydrochloride extended-release tablets) |
7,851,482 8,309,122 8,329,216 8,075,872 8,114,383 8,192,722 8,309,060 |
Millenium Pharma., Inc. v. Actavis, Inc., 12-1750 (D. Del.) |
Dec. 21, 2012 |
Hon. Gregory M. Sleet |
Velcade®(bortezomib injection) |
6,713,446 6,958,319 |
UCB, Inc. v. Teva Pharma. USA, Inc., 12-4420 (N.D. Ga.) |
Dec. 21, 2012 |
Hon. Charles A. Pannell, Jr. |
Metadate CD®(methylphenidate hydrochloride capsules) |
6,344,215 |
Bristol-Myers Squibb Co. v. Dr. Reddy’s Labs., Ltd., 12-7800 (D.N.J.) |
Dec. 21, 2012 |
Hon. Michael A. Shipp |
Ixempra®Kit (ixabepilone for injection) |
6,670,384 7,022,330 RE41,393 |
Shionogi & Co., Ltd. v. Sandoz Inc., 12-7907 (D.N.J.) |
Dec. 28, 2012 |
Hon. Freda L. Wolfson |
Doribax®(doripenem for injection) |
8,247,402 |
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