Share on LinkedInShare on LinkedIn

ARTICLE · 09 JANUARY 2025

New ANDA Cases

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.

United StatesIntellectual Property

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

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).
Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-0775 (D. Del.) Jul 1, 2024 Hon. Colm F. Connolly Ozempic® (semaglutide subcutaneous solution) 8,129,343
10,335,462
Currax Pharms. LLC v. Taro Pharm. Indus. Ltd., 24-7446 (D.N.J.) 1-Jul-24 Jul Silenor® (doxepin HCl tablets) 7,915,307
8,513,299
9,107,898
9,486,437
9,572,814
9,861,607
10,238,620
10,653,660
10,653,662
11,110,074
Bristol-Myers Squibb Co. v. Synthon BV, 24-0780 (D. Del.) 2-Jul-24 Hon. Gregory B. Williams Zeposia® (ozanimod capsules) 11,680,050
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-7511 (D.N.J.) 2-Jul-24 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,969,404
Currax Pharms. LLC v. Taro Pharm. Indus. Ltd., 24-5040 (S.D.N.Y.) 2-Jul-24 Hon. Cathy Seibel Silenor® (doxepin HCl tablets) 7,915,307
8,513,299
9,107,898
9,486,437
9,572,814
9,861,607
10,238,620
10,653,660
10,653,662
11,110,074
Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-0067 (N.D.W.V.) 2-Jul-24 Hon. Thomas S. Kleeh Ozempic® (semaglutide subcutaneous solution) 8,129,343
10,335,462
Veloxis Pharms., Inc. v. Alkem Labs. Ltd., 24-0784 (D. Del.) 3-Jul-24 Hon. Jennifer L. Hall 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
Salix Pharms., Inc. v. Carnegie Pharms., LLC, 24-7531 (D.N.J.) 3-Jul-24 Hon. Susan D. Wigenton Colazal® (balsalazide disodium capsules) 7,452,872
7,625,884
Jazz Pharms. Research UK Ltd. v. Apotex Inc., 24-7550 (D.N.J.) 3-Jul-24 Hon. Michael E. Farbiarz Epidiolex® (cannabidiol oral solution) 11,963,937
Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus. Ltd., 24-0789 (D. Del.) 5-Jul-24 Hon. Jennifer L. Hall Abilify Maintena® (aripiprazole extended-release injectable suspension) 10,525,057
10,980,803
1,154,553
11,344,547
11,400,087
11,648,347
Radius Health, Inc. v. Orbicular Pharm. Technologies Private Ltd., 24-11770 (D. Mass.) 10-Jul-24 Hon. Richard G. Stearns Tymlos® (abaloparatide injection) 11,977,067
Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 24-7680 (D.N.J.) 10-Jul-24 Hon. Madeline Cox Arleo Exparel® (bupivacaine liposome injectable suspension) 11,925,706
Pierre Fabre Medicament SAS v. Rubicon Research Private Ltd., 24-0811 (D. Del.) 12-Jul-24 Hon. Jennifer L. Hall Hemangeol® (propranolol HCl oral solution) 8,338,489
8,987,262
Vanda Pharms. Inc. v. MSN Pharms. Inc., 24-0815 (D. Del.) 12-Jul-24 Hon. Jennifer L. Hall Hetlioz LQ® (tasimelteon oral suspension) 10,179,119
11,266,622
11,285,129
11,850,229
10,610,510
10,980,770
11,759,446
Bristol-Myers Squibb Co. v. Apotex, Inc., 24-0818 (D. Del.) 15-Jul-24 Hon. Gregory B. Williams Zeposia® (ozanimod capsules) 11,680,050
American Regent, Inc. v. Gland Pharma Ltd., 24-7756 (D.N.J.) 15-Jul-24 Hon. Brian R. Martinotti Tralement® (trace zinc, copper, manganese, selenium injection) Multrys® (trace zinc, copper, manganese, selenium injection) 11,786,548
11,975,022
11,998,565
American Regent, Inc. v. Fresenius Kabi USA, LLC, 24-0824 (D. Del.) 16-Jul-24 Hon. Maryellen Noreika Selenious Acid 11,998,565
American Regent, Inc. v. Long Grove Pharms., LLC, 24-0825 (D. Del.) 16-Jul-24 Hon. Maryellen Noreika Selenious Acid 11,998,565
American Regent, Inc. v. Accord Healthcare Inc., 24-7791 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Aspiro Pharma Ltd., 24-7794 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Cipla USA, Inc., 24-7796 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Dr. Reddy's Labs., Inc., 24-7799 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Fresenius Kabi USA, LLC, 24-7801 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Gland Pharma Ltd., 24-7802 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Hikma Pharms. USA Inc., 24-7803 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Long Grove Pharms., LLC, 24-7804 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. RK Pharma, Inc., 24-7805 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-7807 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Steriscience Pte. Ltd., 24-7809 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Sun Pharm. Indus. Ltd., 24-7810 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Xiromed, LLC, 24-7811 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
American Regent, Inc. v. Zydus Pharms. (USA) Inc., 24-7812 (D.N.J.) 16-Jul-24 Hon. Brian R. Martinotti Selenious Acid 11,998,565
Impax Labs., LLC v. Dr. Reddy's Labs., Ltd., 24-7875 (D.N.J.) 18-Jul-24 Hon. Stanley R. Chesler Rytary® (carbidopa / levodopa extended-release capsules) 8,557,283
9,089,608
9,463,246
9,533,046
9,901,640
Allergan Pharms. Int'l Ltd. v. Macleods Pharms. Ltd., 24-0847 (D. Del.) 19-Jul-24 Hon. Maryellen Noreika Savella® (milnacipran HCl tablets) 7,994,220
Ferring Pharms. Inc. v. Jiangsu Hansoh Pharm. Group Co., Ltd., 24-7904 (D.N.J.) 19-Jul-24 Hon. Evelyn Padin Firmagon® (degarelix for injection) 8,841,081
9,877,999
11,766,468
11,826,397
TherapeuticsMD, Inc. v. Sun Pharm. Indus. Ltd., 24-7974 (D.N.J.) 24-Jul-24 Hon. Brian R. Martinotti Imvexxy® (estradiol vaginal inserts) 9,180,091
9,289,382
10,258,630
10,398,708
10,471,072
10,537,581
10,568,891
10,668,082
10,806,697
10,835,487
10,888,516
11,065,197
11,116,717
11,123,283
11,241,445
11,246,875
11,266,661
11,304,959
11,351,182
11,497,709
Teva Branded Pharm. Products R&D, Inc. v. Armstrong Pharms., Inc., 24-0869 (D. Del.) 25-Jul-24 Hon. Maryellen Noreika ProAir® HFA (albuterol sulfate inhalation aerosol) 9,463,289
AstraZeneca Pharms. LP v. Natco Pharma Ltd., 24-8162 (D.N.J.) 31-Jul-24 Hon. Robert Kirsch Lynparza® (olaparib tablets) 12,048,695
AstraZeneca Pharms. LP v. Sandoz Inc., 24-8164 (D.N.J.) 31-Jul-24 Hon. Robert Kirsch Lynparza® (olaparib tablets) 12,048,695
AstraZeneca Pharms. LP v. Cipla Ltd., 24-8167 (D.N.J.) 31-Jul-24 Hon. Robert Kirsch Lynparza® (olaparib tablets) 12,048,695
Astellas Pharma Inc. v. Qilu Pharm. (Hainan) Co., Ltd., 24-8217 (D.N.J.) Aug. 1, 2024 Hon. Michael A. Shipp Xtandi® (enzalutamide tablets) 7,709,517
11,839,689
Viiv Healthcare Co. v. Hetero USA Inc., 24-0907 (D. Del.) Aug. 2, 2024 Hon. Mitchell S. Goldberg Dovato® (dolutegravir / lamivudine tablets) 9,242,986
11,234,985
Astellas Pharma Inc. v. Qilu Pharm. (Hainan) Co., Ltd., 24-3747 (E.D. Pa.) Aug. 1, 2024 Hon. Wendy Beetlestone Xtandi® (enzalutamide tablets) 7,709,517
11,839,689
AstraZeneca AB v. Sciegen Pharms., Inc., 24-0923 (D. Del.) Aug. 8, 2024 Hon. Richard G. Andrews Farxiga® (dapagliflozin tablets) 8,685,934
7,851,502
8,221,786
8,361,972
8,716,251
7,919,598
8,501,698
AbbVie Inc. v. Hetero USA, Inc., 24-0924 (D. Del.) Aug. 8, 2024 Hon. Maryellen Noreika Rinvoq® (upadacitinib tablets) RE47,221
8,962,629
11,976,077
11,993,605
11,993,606
Axsome Malta Ltd. v. Alkem Labs. Ltd., 24-8365 (D.N.J.) Aug. 8, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,969,404
11,986,454
11,986,455
11,998,639
12,005,036
Pfizer Inc. v. SpecGx LLC, 24-0927 (D. Del.) Aug. 9, 2024 Hon. Colm F. Connolly Xeljanz® (tofacitinib tablets) RE41,783
Astellas Pharma Inc. v. Lupin Ltd., 24-0939 (D. Del.) Aug. 13, 2024 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 12,059,409
Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 24-0940 (D. Del.) Aug. 13, 2024 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 12,059,409
Harmony Biosciences, LLC v. AET Pharma US, Inc., 24-0941 (D. Del.) Aug. 13, 2024 Hon. Jennifer L. Hall Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
American Regent, Inc. v. Cipla USA, Inc., 24-8435 (D.N.J.) Aug. 13, 2024 Hon. Brian R. Martinotti Tralement® (trace elements injection 4*, USP) 11,786,548
11,975,022
11,998,565
Janssen Products, L.P. v. Ever Valinject GmbH, 24-7319 (N.D. Ill.) Aug. 15, 2024 Hon. Sunil R. Harjani Yondelis® (trabectedin injection) 8,895,557
7,420,051
Pfizer Inc. v. Ajanta Pharma Ltd., 24-0953 (D. Del.) Aug. 16, 2024 Hon. Colm F. Connolly Xeljanz® XR (tofacitinib citrate extended-release tablets) RE41,783
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 24-8558 (D.N.J.) Aug. 19, 2024 Hon. Karen M. Williams Yupelri® (revefenacin inhalation solution) 12,048,692
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-8624 (D.N.J.) Aug. 21, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,986,454
11,986,455
11,998,639
12,005,036
Ipsen Biopharms., Inc. v. Conjupro Biotherapeutics, Inc., 24-8723 (D.N.J.) Aug. 23, 2024 Hon. Renee Marie Bumb Onivyde® (irinotecan liposome injection) 12,059,497
Jazz Pharms. Ireland Ltd. v. Teva Pharms., Inc., 24-8785 (D.N.J.) Aug. 27, 2024 Hon. Stanley R. Chesler Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) 11,986,446
Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 24-8786 (D.N.J.) Aug. 27, 2024 Hon. Stanley R. Chesler Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) 11,986,446
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 24-8809 (D.N.J.) Aug. 28, 2024 Susan D. Wigenton Firvanq® (vancomycin HCl oral solution) 10,493,028
10,688,046
10,959,946
10,959,947
10,959,948
10,959,949
11,638,692
Takeda Pharms. U.S.A., Inc. v. Colomba Therapeutics, Inc., 24-0988 (D. Del.) Aug. 29, 2024 Hon. Richard G. Andrews Myinfla® (colchicine tablets) Colcrys® (colchicine tablets) 7,964,648
Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-08845 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-08848 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. Dr. Reddy's Labs. Inc., 24-08850 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-08852 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-08854 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-08855 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 24-08856 (D.N.J.) Aug. 29, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 11,980,617
12,070,459
Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 24-0082 (N.D.W.V.) Aug. 30, 2024 Hon. Thomas S. Kleeh Tradjenta® (linagliptin tablets) Jentadueto® (linagliptin / metformin tablets) 11,911,388
Otsuka Pharm. Co., Ltd. v. Apotex Inc., 24-1004 (D. Del.) Aug. 30, 2024 Hon. Jennifer L. Hall Abilify Maintena® (aripiprazole extended-release injectable suspension) 10,525,057
10,980,803
11,154,553
11,344,547
11,400,087
11,648,347
Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-1013 (D. Del.) Sept. 5, 2024 Hon. Colm F. Connolly Wegovy® (semaglutide injection) 12,029,779
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 24-1014 (D. Del.) Sept. 5, 2024 Hon. Colm F. Connolly Wegovy® (semaglutide injection) 12,029,779
American Regent, Inc. v. Eugia Pharma Specialities Ltd., 24-8956 (D.N.J.) Sept. 5, 2024 Hon. Brian R. Martinotti Selenious Acid 11,998,565
Rayner Surgical Inc. v. Somerset Therapeutics, LLC, 24-9017 (D.N.J.) Sept. 6, 2024 Hon. Evelyn Padin Omidria® (phenylephrine / ketorolac injection) 9,066,856
9,486,406
9,855,246
Ingenus Pharms., LLC v. Hetero USA, Inc., 24-1025 (D. Del.) Sept. 11, 2024 Hon. Jennifer L. Hall cyclophosphamide injection 10,993,952
Jazz Pharms. Ireland Ltd. v. Sandoz, Inc., 24-9110 (D.N.J.) Sept. 11, 2024 Hon. Robert Kirsch Zepzelca® (lurbinectedin injection) 7,763,615
Jazz Pharms. Ireland Ltd. v. RK Pharma, Inc., 24-1028 (D. Del.) Sept. 12, 2024 Hon. Gregory B. Williams Zepzelca® (lurbinectedin injection) 7,763,615
Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 24-9134 (D.N.J.) Sept. 12, 2024 Hon. Stanley R. Chesler Erleada® (apalutamide tablets) 11,963,952
Boehringer Ingelheim Pharms., Inc. v. Anobri Pharms. US, LLC, 24-9135 (D.N.J.) Sept. 12, 2024 Hon. Claire C. Cecchi Stiolto® Respimat® (tiotropium bromide / olodaterol HCl inhalation spray) 7,396,341
9,027,967
7,837,235
8,733,341
Jazz Pharms. Ireland Ltd. v. InvaGen Pharms., Inc., 24-6416 (E.D.N.Y.) Sept. 12, 2024 Hon. Joan M. Azrack Zepzelca® (lurbinectedin injection) 7,763,615
Novartis Pharms. Corp. v. Natco Pharma Ltd., 24-1033 (D. Del.) Sept. 13, 2024 Hon. Jennifer L. Hall Kisqali® (ribociclib tablets) 9,193,732
9,868,739
Mallinckrodt Pharms. Ireland Ltd. v. Baxter Healthcare Corp., 24-1034 (D. Del.) Sept. 13, 2024 Hon. Gregory B. Williams Ofirmev® (acetaminophen injection) 9,399,012
9,610,265
9,987,238
10,383,834
Axsome Malta Ltd. v. Alkem Labs. Ltd., 24-9209 (D.N.J.) Sept. 16, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,969,404
11,986,454
11,986,455
11,998,639
12,005,036
12,036,194
12,064,411
Novartis Pharms. Corp. v. Lupin Inc., 24-1045 (D. Del.) Sept. 18, 2024 Hon. Richard G. Andrews Entresto® (sacubitril / valsartan tablets) 8,101,659
11,096,918
Supernus Pharms., Inc. v. Micro Labs Ltd., 24-9338 (D.N.J.) Sept. 20, 2024 Hon. Zahid N. Quraishi Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
Supernus Pharms., Inc. v. Aurobindo Pharma Ltd., 24-9380 (D.N.J.) Sept. 23, 2024 Hon. Karen M. Williams Oxtellar XR® (oxcarbazepine extended-release tablets) 7,722,898
7,910,131
8,617,600
8,821,930
9,119,791
9,351,975
9,370,525
9,855,278
10,220,042
11,166,960
11,896,599
Endo Operations, Ltd. v. Fresenius Kabi USA, LLC, 24-1065 (D. Del.) Sept. 24, 2024 Hon. Maryellen Noreika Adrenalin® (epinephrine injection) 9,119,876
9,295,657
10,130,592
Astellas Pharma Inc. v. Lupin Ltd., 24-1068 (D. Del.) Sept. 24, 2024 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 12,097,189
Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 24-1069 (D. Del.) Sept. 24, 2024 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 12,097,189
Astellas Pharma Inc. v. Haimen Pharma Inc., 24-9403 (D.N.J.) Sept. 24, 2024 Hon. Michael A. Shipp Xtandi® (enzalutamide tablets) 7,709,517
11,839,689
Hikma Pharms. USA Inc. v. SK Biopharmaceuticals Co., Ltd., IPR2024-01418 (PTAB) Sept. 24, 2024 N/A Sunosi® (solriamfetol HCl tablets) 11,560,354
Esperion Therapeutics, Inc. v. Aurobindo Pharma Ltd., 24-9457 (D.N.J.) Sept. 25, 2024 Hon. Julien Xavier Neals Nexlizet® (bempedoic acid / ezetimibe tablets)) 11,760,714
11,613,511
10,912,751
11,744,816
11,926,584
Ultragenyx Pharm. Inc. v. Navinta LLC, 24-9483 (D.N.J.) Sept. 26, 2024 Hon. Esther Salas Dojolvi® (triheptanoin oral liquid) 8,697,748
Astellas Pharma Inc. v. Ascent Pharms., Inc., 24-1084 (D. Del.) Sept. 27, 2024 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 12,059,409
11,707,451
12,097,189
Salix Pharms., Inc. v. Zydus Pharms. (USA) Inc., 24-9512 (D.N.J.) Sept. 27, 2024 Hon. Edward S. Kiel Xifaxan® (rifaximin tablets) 11,779,571
11,564,912
8,193,196
8,518,949
8,741,904
9,271,968
10,703,763
Bristol-Myers Squibb Co. v. Umedica Labs. Pvt. Ltd., 24-1089 (D. Del.) Sept. 30, 2024 Hon. Gregory B. Williams Eliquis® (apixaban tablets) 9,326,945
Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 24-1091 (D. Del.) Sept. 30, 2024 Hon. Colm F. Connolly Jentadueto® (linagliptin / metformin HCl tablets) 9,155,705
9,415,016
10,022,379
10,973,827
11,911,388
Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 24-9535 (D.N.J.) Sept. 30, 2024 Hon. Madeline Cox Arleo Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) 11,986,444
12,036,191
12,042,473

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

See more popular content from