New ANDA Cases

Federal district court cases that are filed pursuant to the Hatch-Waxman Act

Second Quarter

GENERICally Speaking

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.

Case Name Date Filed Judge Drug Patent No(s).
Exeltis USA, Inc. v. Lupin Ltd., 22-0434 (D. Del.) Apr. 1, 2022 Honorable Richard G. Andrews Slynd® (drospirenone tablets) 9,603,860
10,179,140
10,603,281
10,849,857
10,987,364
11,123,299
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 22-0439 (D. Del.) Apr. 1, 2022 Honorable MaryEllen Noreika Ingrezza® (valbenazine capsules) 10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
Novartis Pharms. Corp. v. Zydus Pharms. (USA) Inc., 22-0440 (D. Del.) Apr. 1, 2022 Honorable Richard G. Andrews Entresto® (sacubitril / valsartan tablets) 11,058,667
Azurity Pharms., Inc. v. CoreRx, Inc., 22- 0784 (M.D. Fla.) Apr. 1, 2022 Honorable Steven D. Merryday Epaned® (enalapril maleate oral solution) 11,040,023
11,141,405
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 22-1882 (D.N.J.) Apr. 1, 2022 Honorable Christine P. O'Hearn Ingrezza® (valbenazine capsules) 10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
Merck Sharp & Dohme Corp. v. Mankind Pharma Ltd., 22-0444 (D. Del.) Apr. 4, 2022 Honorable Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Celgene Corp. v. MSN Labs. Private Ltd., 22- 1993 (D.N.J.) Apr. 6, 2022 Honorable Esther Salas Pomalyst® (pomalidomide capsules) 8,198,262
8,673,939
8,735,428
8,828,427
9,993,467
10,555,939
Evoke Pharma, Inc. v. Teva Pharms., Inc., 22- 2019 (D.N.J.) Apr. 7, 2022 Honorable Renee Marie Bumb Gimoti® (metoclopramide nasal spray) 8334281
11,020,361
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0464 (D. Del.) Apr. 8, 2022 Honorable Colm F. Connolly Abilify Maintena® (aripiprazole extended-release injection) 7,807,680
8,030,313
8,722,679
8,399,469
8,338,427
10,525,057
10,980,803
11,154,553
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0032 (N.D.W.V.) Apr. 8, 2022 Honorable Thomas S. Kleeh Abilify Maintena® (aripiprazole extended-release injection) 7,807,680
8,030,313
8,722,679
8,399,469
8,338,427
10,525,057
10,980,803
11,154,553
Bayer Intellectual Property GmbH v. Changzhou Pharm. Factory, 22-2089 (D.N.J.)  Apr. 11, 2022 Honorable Kevin McNulty Xarelto® (rivaroxaban tablets) 9,539,218
Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 22-0487 (D. Del.) Apr. 14, 2022 Honorable Maryellen Noreika Xyrem® (sodium oxybate oral solution) 10,758,488
10,813,885
10,959,956
10,966,931
11,077,079
11,147,782
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 22-0498 (D. Del.) Apr. 19, 2022 Honorable Richard G. Andrews Entresto® (sacubitril / valsartan tablets)  11,058,667
Arbor Pharms., LLC v. Amneal Pharms., LLC, 22-2323 (D.N.J.) Apr. 21, 2022 Honorable Karen W. Williams Nymalize® (nimodipine oral solution) 7,070,581
8,517,997
10,342,787
10,576,070
11,207,306
Otsuka Pharm. Co., Ltd. v. Teva Pharms. Inc., 22-0513 (D. Del.) Apr. 22, 2022 Honorable Richard G. Andrews Jynarque® (tolvaptan tablets) 8501730
10,905,694
BioMarin Pharm. Inc. v. Aurobindo Pharms. Ltd., 22-2345 (D.N.J.) Apr., 22, 2022 Honorable Michael A. Shipp Kuvan® (sapropterin dihydrochloride tablets) 7,566,462
7,566,714
7,612,073
7,727,987
8,003,126
8,067,416
RE43,797
8,318,745
9,433,624
Astellas US LLC v. GE Healthcare Inc., 22-0523 (D. Del.) Apr. 25, 2022 Honorable Colm F. Connolly Lexiscan® (regadenoson intravenous solution) 8106183
RE47,301
8,524,883
AstraZeneca AB v. Mylan Pharms. Inc., 22-0035 (N.D.W.V.) Apr. 26, 2022 Honorable Gina M. Groh Symbicort® (budesonide / formoterol fumarate dehydrate inhalation aerosol) 11,311,558
Alcon Inc. v. Somerset Therapeutics, LLC, 22- 0543 (D. Del) Apr. 27, 2022 Vacant Judgeship (2022) Pataday® Once- Daily (olopatadine HCl ophthalmic solution) 8,791,154
9,533,053
Journey Medical Corp. v. Padagis Israel Pharms. Ltd., 22-0587 (D. Del.) May 2, 2022 Honorable Colm F. Connolly Zilxi® (minocycline topical foam) 8,865,139
8,945,516
8,992,896
9,675,700
10,213,512
10,265,404
10,322,186
10,946,101
Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 22- 0591 (D. Del) May 2, 2022 Honorable Leonard P. Stark Rexulti® (brexpiprazole tablets) 8,618,109
9,839,637
Gilead Sciences, Inc. v. Lupin Ltd., 22-0615 (D. Del.) May 9, 2022 Honorable MaryEllen Noreika Biktarvy® (bictegravir sodium / tenofovir alafenamide fumarate /
emtricitabine tablets) 
9,708,342
10,385,067
10,548,846
Bristol-Myers Squibb Co. v. Nanocopoeia, LLC, 22-1283 (D. Minn)  May 10, 2022 Honorable Katherine M. Mendenez Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Abraxis BioScience, LLC v. Jiangsu Hengrui Pharms. Co., Ltd., 22-2745 (D.N.J.) May 11, 2022 Honorable Freda L. Wolfson Abraxane® (paclitaxel protein- bound particles for injectable suspension) 7,820,788
Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 22- 2773 (D.N.J.) May 11, 2022 Honorable Stanley R. Chesler Xywav® (calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate oral solution) 11,253,494
Aragon Pharms., Inc. v. Lupin Ltd., 22-0637 (D. Del.) May 13, 2022 Hon. Colm F. Connolly Erleada® (apalutamide tablets) 9,481,663
Neurocrine Biosciences, Inc. v. Lupin Ltd., 22-0639 (D. Del.)  May 13, 2022 Honorable MaryEllen Noreika Ingrezza® (valbenazine tosylate capsules) 8,039,627
8,357,697
10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
Horizon Medicines LLC v. Apotex Inc., 22- 0640 (D. Del.) May 13, 2022 Honorable Christopher J. Burke Pennsaid® (diclofenac sodium topical solution) 9,066,913
Par Pharm., Inc. v. Cipla Ltd., 22-2814 (D.N.J.) May 13, 2022 Honorable Madeline C. Arleo Vasostrict® (vasopressin injection) 9,919,026
9,925,233
9,962,422
9,968,649
9,974,827
9,981,006
10,010,575
Aragon Pharms., Inc. v. Lupin Ltd., 22-2825 (D.N.J.) May 13, 2022 Hon. Julien Xavier Neals Erleada® (apalutamide tablets) 9,481,663
Celgene Corp. v. Oncogen Pharma (Malaysia) Sdn. Bhd., 22-2952 (D.N.J.) May 20, 2022 Honorable Susan D. Wigenton  Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
7,968,569
8,530,498
8,648,095
9,101,621
9,101,622
Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 22-2964 (D.N.J.)  May 20, 2022 Honorable Julien Xavier Neals Erleada® (apalutamide tablets) 9,481,663
9,884,054
10,052,314
10,702,508
10,849,888
Momenta Pharms., Inc. v. Mylan Pharms., Inc., 22-0750 (W.D. Pa.) May 20, 2022 Honorable Robert J. Colville Glatopa® (glatiramer acetate injection) 8,859,489
9.395,374
Aragon Pharms., Inc. v. Sandoz Inc., 22-0678 (D. Del.) May 24, 2022 Honorable Colm F. Connolly Erleada® (apalutamide tablets) 8,445,507
8,802,689
9,388,159
9,481,663
9,987,261
Aragon Pharms., Inc. v. Sandoz Inc., 22-3044 (D.N.J.) May 24, 2022 Honorable Julien Xavier Neals Erleada® (apalutamide tablets) 8,445,507
8,802,689
9,388,159
9,481,663
9,987,261
Aragon Pharms., Inc. v. Eugia Pharma Specialities Ltd. (A.K.A. Eugia Pharma Specialties Ltd.), 22- 0688 (D. Del.) May 26, 2022 Honorable Colm F. Connolly Erleada® (apalutamide tablets) 8,445,507
8,802,689
9,388,159
9,481,663
9,987,261
Aragon Pharms., Inc. v. Eugia Pharma Specialities Ltd. (A.K.A. Eugia Pharma Specialties Ltd.), 22- 0688 (D. Del.) May 26, 2022 Honorable Julien Xavier Neals Erleada® (apalutamide tablets) 8,445,507
8,802,689
9,388,159
9,481,663
9,987,261
Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 22-0696 (D. Del.)  May 27, 2022 Honorable Colm F. Connolly Erleada® (apalutamide tablets) 8,445,507
9,481,663
9,884,054
10,052,314
10,702,508
10,849,888
Eagle Pharms., Inc. v. Accord Healthcare Inc., 22-0704 (D. Del.) May 27, 2022 Honorable Colm F. Connolly Belrapzo® (bendamustine HCl injection) 8,609,707
9,265,831
9,572,796
9,572,797
10,010,533
11,103,483
Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 22-3212 (D.N.J.) May 27, 2022 Hon. Julien Xavier Neals Erleada® (apalutamide tablets) 8,445,507
9,481,663
9,884,054
10,052,314
10,702,508
10,849,888
Ingenus Pharms., LLC v. Nexus Pharms., Inc., 22-2868 (N.D. Ill.) June 1, 2022 Honorable Mary M. Rowland cyclophosphamide injection 10,993,952
Galderma Labs., L.P. v. Apotex Inc., 22-0724 (D. Del.) June 2, 2022 Honorable Stephanos Bibas Oracea® (doxycycline capsules) 7,749,532
8,206,740
Novartis Pharms. Corp. v. Biocon Pharma Ltd., 22-0726 (D. Del.) June 2, 2022 Honorable Richard G. Andrews Entresto® (sacubitril / valsartan tablets) 11,058,667
Vertex Pharms. Inc. v. Aurobindo Pharma Ltd., 22 - 0728 (D. Del.)  June 2, 2022 Honorable Richard G. Andrews Kalydeco® (ivacaftor tablets) 10,646,481
Avion Pharms., LLC v. Lupin Ltd., 22-0729 (D. Del.) June 2, 2022 Honorable Colm F. Connolly Balcoltra® (levonorgestrel ethinyl estradiol / ferrous bisglycinate tablets) 7,838,042
Novartis Pharms. Corp. v. Accord Healthcare Inc., 22- 0744 (D. Del.)  June 6, 2022 Honorable MaryEllen Noreika Rydapt® (midostaurin capsules) 7,973,031
Pfizer Inc. v. MSN Labs. Private Ltd., 22- 0746 (D. Del.) June 6, 2022 Honorable Colm F. Connolly Xeljanz® (tofacitinib oral solution) RE41,783
Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 22-3505 (D.N.J.)  June 6, 2022 Honorable  Noel L. Hillman Sprycel® (dasatinib tablets) 7491725
8,680,103
Novartis Pharms. Corp. v. Accord Healthcare Inc., 22- 0431 (M.D.N.C.) June 6, 2022 Honorable William L. Osteen, Jr.  Rydapt® (midostaurin capsules) 7,973,031
Eisai Co., Ltd. v. Aurobindo Pharma Ltd., 22-3610 (D.N.J.) June 8, 2022 Honorable Christine P. O'Hearn Banzel® (rufinamide tablets) 6,740,669
Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01102 (PTAB)  June 10, 2022 N/A Trulance® (plecanatide tablets) 9,610,321
Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01103 (PTAB) June 10, 2022 N/A Trulance® (plecanatide tablets) 9,616,097
Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01104 (PTAB)  June 10, 2022 N/A Trulance® (plecanatide tablets) 9,919,024
Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-01105 (PTAB) June 10, 2022 N/A Trulance® (plecanatide tablets) 9,925,231
Bristol-Myers Squibb Co. v. Accord Healthcare Inc., 22- 3743 (D.N.J.)  June 13, 2022 Honorable Renee Marie Bumb Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Celgene Corp. v. Qilu Pharm. Co., Ltd., 22- 3753 (D.N.J.)  June 13, 2022 Honorable Susan D. Wigenton  Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
Amgen Inc. v. Apotex Inc., 22-3827 (D.N.J.) June 14, 2022 Honorable Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
9,872,854
10,092,541
Astellas Pharma Inc. v. Sawai Pharm. Co., Ltd., 22-0818 (D. Del.) June 17, 2022 Honorable Joseph F. Bataillon  Myrbetriq® (mirabegron extended-release tablets) 6,346,532
7,342,117
7,982,049
8,835,474
RE44,872
10,842,780
Scilex Pharms. Inc. v. Aveva Drug Delivery Systems, Inc., 22-61192 (S.D. Fla.) June 22, 2022 Honorable William P. Dimitrouleas ZTlido® (lidocaine topical system) 9,283,174
9,925,264
9,931,403
Gilead Sciences, Inc. v. Natco Pharma Ltd., 22- 0852 (D. Del.) June 23, 2022 Honorable Richard G. Andrews Zydelig® (idelalisib tablets) RE44,599
RE44,638
8,865,730
9,469,643
10,730,879
Chemo Research SL v. Encube Ethicals Private, Ltd., 22-0854 (D. Del.) June 24, 2022 Honorable Colm F. Connolly Nuvessa® (metronidazole vaginal gel) 7,893,097
8,658,678
8,877,792
8,946,276
9,198,858
10,238,634
10,596,155
Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 22-0856 (D. Del.) June 24, 2022 Honorable Colm F. Connolly Saxenda® (liraglutide recombinant solution injection) 7,762,994
8,114,833
8,579,869
8,684,969
8,920,383
9,108,002
9,132,239
9,457,154
9,616,180
9,687,611
9,775,953
9,861,757
10,220,155
10,357,616
10,376,652
11,097,063
11,311,679
RE46,363
Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., 22-4248
(D.N.J.) 
June 24, 2022 Honorable Madeline Cox Arleo Arazlo® (tazarotene lotion) 11,311,482
Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-4328 (D.N.J.) June 29, 2022 Hon. Renee Marie Bumb Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Bausch & Lomb Inc. v. Gland Pharma Ltd., 22-4345 (D.N.J.) June 30, 2022 Honorable Michael A. Shipp Vyzulta® (latanoprostene bunod ophthalmic solution) 7,273,946
7,629,345
7,910,767
8,058,467

Oren D. Langer

Partner

Managing Partner, New York Office

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