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).
UroGen Pharma Ltd. v. Teva Pharms., Inc., 24-0417 (D. Del.) Apr. 2, 2024 Hon. Colm F. Connolly Jelmyto® (mitomycin for pyelocalyceal solution) 9040074
9950069
Novartis Pharms. Corp. v. Teva Pharms., Inc., 24-0428 (D. Del.) Apr. 4, 2024 Hon. Gregory B. Williams Tasigna® (nilotinib HCl capsules) 8,163,904
8,293,756
8,389,537
8,415,363
8,501,760
9,061,029
Janssen Pharms., Inc. v. Macleods Pharms., Ltd., 24-4564 (D.N.J.) Apr. 4, 2024 Hon. Georgette Castner Invokamet® (canagliflozin / metformin HCl tablets) 11,576,894
Horizon Therapeutics U.S. Holding LLC v. Teva Pharms., Inc., 24-0432 (D. Del.) Apr. 5, 2024 Hon. Gregory B. Williams Ravicti® (glycerol phenylbutyrate oral liquid) 8,642,012
9,254,278
9,326,966
9,561,197
9,962,359
9,999,608
10,045,958
10,045,959
10,183,002
10,183,003
10,183,004
10,183,005
10,183,006
10,668,040
Actelion Pharms. Ltd. v. Gland Pharma Ltd., 24-0434 (D. Del.) Apr. 5, 2024 Hon. Jennifer L. Hall Veletri® (epoprostenol sodium for injection) 8,598,227
Upsher-Smith Labs., LLC v. AMTA Labs Ltd., 24-0058 (D. Del.) Jan. 17, 2024 Hon. Gregory B. Williams Qudexy® XR (topiramate extended-release capsules) 10,363,224
AbbVie Inc. v. Zydus Pharms. (USA) Inc., 24-4603 (D.N.J.) Apr. 5, 2024 Hon. Zahid N. Quraishi Ubrelvy® (ubrogepant tablets) 10,117,836
11,717,515
11,857,542
11,925,709
Salix Pharms., Inc. v. Amneal Pharms. of NY, LLC, 24-4607 (D.N.J.) Apr. 5, 2024 Hon. Edward S. Kiel Xifaxan® (rifaximin tablets) 11,779,571
11,564,912
10,456,384
8,193,196
8,518,94
8,741,90
9,271,968
10,703,763
Axsome Malta Ltd. v. Alkem Labs. Ltd., 24-4608 (D.N.J.) Apr. 5, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,771,666
11,771,667
11,779,554
11,793,776
11,839,598
11,839,599
11,850,226
11,850,227
11,850,228
11,857,528
11,865,098
11,872,203
11,872,204
Bausch Health Ireland Ltd. v. Mylan Pharms. Inc., 24-0036 (N.D.W.V.) Apr. 5, 2024 Hon. Thomas S. Kleeh Trulance® (plecanatide tablets) 11,834,521
Chiesi Farmaceutici S.p.A v. Teva Pharms Inc., 24-0441 (D. Del.) Apr. 8, 2024 Hon. Colm F. Connolly Mycapssa® (octreotide delayed-release capsules) 8,329,198
8,535,695
9,265,812
9,566,246
10,238,709
10,695,397
11,052,126
11,141,457
11,338,011
11,510,963
11,857,595
11,890,316
Abbvie Inc. v. MSN Pharms. Inc., 24-4662 (D.N.J.) Apr. 8, 2024 Hon. Zahid N. Quraishi Ubrelvy® (ubrogepant tablets) 10,117,836
11,717,515
11,857,542
11,925,709
Vertex Pharms. Inc. v. Lupin Ltd., 24-0458 (D. Del.) Apr. 11, 2024 Hon. Richard G. Andrews Kalydeco® (ivacaftor granules) 8,883,206
10,272,046
10,646,481
11,147,770
11,564,916
11,752,106
AstraZeneca AB v. Laurus Labs Ltd., 24-0459 (D. Del.) Apr. 11, 2024 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
AbbVie Inc. v. Hetero USA Inc., 24-4852 (D.N.J.) Apr. 11, 2024 Hon. Zahid N. Quraishi Ubrelvy® (ubrogepant tablets) 10,117,836
11,717,515
11,857,542
11,925,709
Ipsen Biopharms., Inc. v. Conjupro Biotherapeutics, Inc., 24-4991 (D.N.J.) Apr. 15, 2024 Hon. Renee Marie Bumb Onivyde® (irinotecan liposome injection) 8,329,213
9,339,49
9,364,473
9,452,162
9,492,442
9,717,724
10,980,795
11,369,597
Impax Labs., LLC v. Ascent Pharms. Inc., 24-5299 (D.N.J.) Apr. 18, 2024 Hon. Karen M. Williams Rytary® (carbidopa / levodopa extended-release capsules) 8,377,474
8,454,998
8,557,283
9,089,607
9,089,608
9,463,246
9,533,04
9,901,640
Encube Ethicals Pvt. Ltd. v. Dermavant Sciences GmbH, IPR2024-00834 (PTAB) Apr. 23, 2024 N/A Vtama® (tapinarof topical cream) 11,590,088
Fresenius Kabi USA, LLC v. Accord Healthcare Inc., 24-5674 (D.N.J.) Apr. 26, 2024 Hon. Susan D. Wigenton levothyroxine sodium injection 10,398,669
11,135,190
Merck Sharp & Dohme LLC v. Azurity Pharms., Inc., 24-0545 (D. Del.) 3-May-24 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate oral solution) 7,326,708
Viiv Healthcare Co. v. Hetero USA, Inc., 24-0547 (D. Del.) 3-May-24 Hon. Mitchell S. Goldberg Tivicay® (dolutegravir sodium tablets) 9,242,986
Mitsubishi Tanabe Pharma Corp. v. Apotex Inc., 24-0549 (D. Del.) 3-May-24 Hon. Jennifer L. Hall Radicava ORS® (edaravone oral suspension) 10,987,341
11,241,416
11,478,450
11,826,352
Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 24-5847 (D.N.J.) 3-May-24 Hon. Evelyn Padin Reyvow® (lasmiditan tablets) 11,053,214
AstraZeneca AB v. Apotex Inc., 24-0551 (D. Del.) 6-May-24 Hon. Richard G. Andrews Xigduo XR® (dapagliflozin / metformin HCl extended-release tablets) 7,919,598
8,501,698
8,685,934
9,616,028
Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-5856 (D.N.J.) 6-May-24 Hon. Stanley R. Chesler QVAR RediHaler® (beclomethasone dipropionate inhalation aerosol) 11,793,953
11,865,247
11,896,759
AstraZeneca Pharms. LP v. Natco Pharma Ltd., 24-5887 (D.N.J.) 7-May-24 Hon. Robert Kirsch Lynparza® (olaparib tablets) 11,970,530
11,975,001
AstraZeneca Pharms. LP v. Sandoz Inc., 24-5889 (D.N.J.) 7-May-24 Hon. Robert Kirsch Lynparza® (olaparib tablets) 11,970,530
11,975,001
Neurelis, Inc. v. Padagis LLC, 24-0562 (D. Del.) 8-May-24 Hon. Maryellen Noreika Valtoco® (diazepam nasal spray) 8,895,546
11,241,414
11,793,786
Esperion Therapeutics, Inc. v. Micro Labs USA, Inc., 24-5921 (D.N.J.) 8-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 11,760,714
11,613,511
Exelixis, Inc. v. Cipla, Ltd., 24-0565 (D. Del.) 9-May-24 Hon. Richard G. Andrews Cabometyx® (cabozantinib (S)-malate tablets) 8,877,776
11,091,439
11,091,440
11,098,015
11,298,349
Breckenridge Pharm., Inc. v. Hetero USA Inc., 24-0571 (D. Del.) 10-May-24 Hon. Gregory B. Williams Pradaxa® (dabigatran etexilate mesylate capsules) 11,013,729
11,752,142
Esperion Therapeutics, Inc. v. Renata Ltd., 24-6017 (D.N.J.) 10-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 11,760,714
11,613,511
Apotex Inc. v. Boehringer Ingelheim Pharms. Inc., 24-0577 (D. Del.) 13-May-24 Hon. Maryellen Noreika Ofev® (nintedanib esylate capsules) 9,907,756
10,105,323
Grünenthal GmbH v. Teva Pharms., Inc., 24-6104 (D.N.J.) 13-May-24 Hon. Stanley R. Chesler Nucynta® ER (tapentadol HCl extended-release tablets) 11,344,512
Acerta Pharma B.V. v. Cipla Ltd., 24-0587 (D. Del.) 16-May-24 Hon. Gregory B. Williams Calquence® (acalabrutinib tablets) 10,272,083
11,059,829
Bayer Intellectual Property GmbH v. Ascent Pharms. Inc., 24-0588 (D. Del.) 16-May-24 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
Esperion Therapeutics, Inc. v. Accord Healthcare Inc., 24-6224 (D.N.J.) 16-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 11,760,714
11,613,511
11,926,584
Esperion Therapeutics, Inc. v. Alkem Labs. Ltd., 24-6263 (D.N.J.) 17-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) 11,760,714
11,613,511
10,912,751
11,744,816
Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 24-6294 (D.N.J.) 20-May-24 Hon. Madeline Cox Arleo Exparel® (bupivacaine liposome injectable suspension) 11,819,574
11,819,575
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 24-4180 (N.D. Ill.) 21-May-24 Hon. John F. Kness Minocin® (minocycline for injection) 11,944,634
Purdue Pharma L.P. v. Accord Healthcare Inc., 24-0284 (E.D.N.C.) 21-May-24 Hon. Louise Wood Flanagan OxyContin® (oxycodone HCl extended-release tablets) 11,826,472
11,904,055
11,938,225
11,964,056
Esperion Therapeutics, Inc. v. Aurobindo Pharma Ltd., 24-6348 (D.N.J.) 22-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 11,760,714
11,613,511
Pfizer Inc. v. Apotex Inc., 24-0621 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 8,314,117
8,759,372
11,083,724
Pfizer Inc. v. Aurobindo Pharma Ltd., 24-0622 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 11,083,724
Pfizer Inc. v. Changzhou Pharm. Factory, 24-0623 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 8,314,117
8,759,372
11,083,724
Pfizer Inc. v. MSN Labs. Private Ltd., 24-0624 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 11,083,724
Pfizer Inc. v. Natco Pharma Ltd., 24-0625 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 11,083,724
Pfizer Inc. v. Rubicon Research Private Ltd., 24-0626 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 11,083,724
Pfizer Inc. v. Teva Pharms., Inc., 24-0627 (D. Del.) 23-May-24 Hon. Colm F. Connolly Nurtec ODT® (rimegepant sulfate tablets) 11,083,724
Esperion Therapeutics, Inc. v. MSN Pharms. Inc., 24-6386 (D.N.J.) 23-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 11,760,714
11,613,511
Esperion Therapeutics, Inc. v. Sandoz Inc., 24-6387 (D.N.J.) 23-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) 11,926,584
11,760,714
11,613,511
10,912,751
11,744,816
Esperion Therapeutics, Inc. v. Hetero USA Inc., 24-6389 (D.N.J.) 23-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) 7,335,799
11,760,714
11,613,511
Esperion Therapeutics, Inc. v. Dr. Reddy’s Labs. Inc., 24-6391 (D.N.J.) 23-May-24 Hon. Julien Xavier Neals Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) 7,335,799
11,760,714
11,613,511
10,912,751
11,744,816
GE Healthcare Ltd. v. Jubilant Draximage Inc., 24-6486 (D.N.J.) 28-May-24 Hon. Madeline Cox Arleo Myoview™ (technetium Tc99m tetrofosmin for injection) 9,549,999
Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 24-6489 (D.N.J.) 28-May-24 Hon. Michael E. Farbiarz Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) 11,839,612
11,844,797
11,883,373
11,896,563
11,925,636
11,969,421
Viiv Healthcare Co. v. Hetero USA, Inc., 24-0657 (D. Del.) 3-Jun-24 Hon. Mitchell S. Goldberg Triumeq® (abacavir / dolutegravir / lamivudine tablets) 9,242,986
AbbVie Inc. v. Qilu Pharma, Inc., 24-6759 (D.N.J.) 6-Jun-24 Hon. Zahid N. Quraishi Avycaz® (ceftazidime / avibactam for injection) 8,471,025
8,835,455
8,969,566
9,284,314
9,695,122
Eisai R&D Management Co., Ltd. v. Dr. Reddy’s Labs., Inc., 24-6765 (D.N.J.) 6-Jun-24 Hon. Christine P. O'Hearn Lenvima® (lenvatinib mesylate capsules) 7,612,208
10,407,393
11,186,547
Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 24-6784 (D.N.J.) 6-Jun-24 Hon. Stanley R. Chesler Erleada® (apalutamide tablets) 8,802,689
9,388,159
9,987,261
Vifor (Int’l) AG v. Dr. Reddy’s Labs., Ltd., 24-6833 (D.N.J.) 7-Jun-24 Hon. Georgette Castner Injectafer® (ferric carboxymaltose injection) 7,612,109
7,754,702
8,895,612
11,364,260
11,433,091
11,478,502
Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 24-0698 (D. Del.) 13-Jun-24 Hon. Colm F. Connolly Galafold® (migalastat capsules) 11,833,164
Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 24-0698 (D. Del.) 13-Jun-24 Hon. Colm F. Connolly Galafold® (migalastat capsules) 11,833,164
AbbVie Inc. v. Fresenius Kabi USA, LLC, 24-4914 (N.D. Ill.) 13-Jun-24 Hon. John Robert Blakey Avycaz® (ceftazidime / avibactam for injection) 8,471,025
8,835,455
8,969,566
9,284,314
9,695,122
Merck KGaA v. TWi Pharms., Inc., 24-0700 (D. Del.) 14-Jun-24 Hon. Maryellen Noreika Mavenclad® (cladribine tablets) 7,713,947
8,377,903
Eisai R&D Management Co., Ltd. v. Torrent Pharms. Ltd., 24-7067 (D.N.J.) 17-Jun-24 Hon. Christine P. O’Hearn Lenvima® (lenvatinib mesylate capsules) 7,612,208
10,407,393
11,186,547
SK Biopharms. Co., Ltd. v. Aurobindo Pharma Ltd., 24-0718 (D. Del.) 18-Jun-24 Hon. Jennifer L. Hall Xcopri® (cenobamate tablets) 7,598,279
11,654,133
Janssen Pharms., Inc. v. Qilu Pharm. Co., Ltd., 24-7094 (D.N.J.) 18-Jun-24 Hon. Claire C. Cecchi Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Theravance Biopharma R&D IP, LLC v. Qilu Pharm. Co., Ltd., 24-2689 (E.D. Pa.) 18-Jun-24 Hon. Kai N. Scott Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
11,691,948
11,858,898
Veloxis Pharms., Inc. v. Sun Pharm. Indus. Ltd., 24-0726 (D. Del.) 19-Jun-24 Hon. Joshua D. Wolson Envarsus XR® (tacrolimus extended-release tablets) 8,685,998
9,549,918
10,166,190
10,864,199
11,110,081
11,123,331
11,419,823
Exeltis USA, Inc. v. Lupin Ltd., 24-0732 (D. Del.) 20-Jun-24 Hon. Richard G. Andrews Slynd® (drospirenone tablets) 11,951,213
Salix Pharms., Inc. v. Norwich Pharms., Inc., 24-7140 (D.N.J.) 20-Jun-24 Hon. Robert Kirsch Xifaxan® (rifaximin tablets) 11,779,571
11,564,912
Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus. Ltd., 24-0740 (D. Del.) 21-Jun-24 Hon. Richard G. Andrews Jynarque® (tolvaptan tablets) 8,501,730
10,905,694
8,273,735
Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-7162 (D.N.J.) 21-Jun-24 Hon. Stanley R. Chesler Qvar RediHaler® (beclomethasone dipropionate inhalation aerosol) 11,957,832
Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 24-7182 (D.N.J.) 21-Jun-24 Hon. Stanley R. Chesler Trulance® (plecanatide tablets) 11,834,521
Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 24-0753 (D. Del.) 25-Jun-24 Hon. Colm F. Connolly Tradjenta® (linagliptin tablets) 9,486,526
10,034,877
Pfizer Inc. v. Biocon Ltd., 24-0757 (D. Del.) 26-Jun-24 Hon. Colm F. Connolly Xeljanz® XR (tofacitinib citrate extended-release tablets) RE41,783
AstraZeneca Pharms. LP v. Cipla Ltd., 24-7346 (D.N.J.) 28-Jun-24 Hon. Robert Kirsch Lynparza® (olaparib tablets)  8,859,562
11,970,530
11,975,001
8,475,842
11,633,396

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