New ANDA Cases

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

Third 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).
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0896 (D. Del.) July 1, 2022 Hon. 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
9,968,659
10,220,155
10,357,616
10,376,652
11,097,063
11,311,679
RE 46,363
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0897 (D. Del.) July 1, 2022 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution injection) 7,762,994
8,114,833
8,579,869
9,265,893
AstraZeneca AB v. USV Private Ltd., 22-0899 (D. Del.) July 1, 2022 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
Supernus Pharms., Inc. v. Alkem Labs. Ltd., 22-3511 (N.D. Ill.) July 6, 2022 Hon. Elaine E. Bucklo 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
Veloxis Pharms., Inc. v. Accord Healthcare, Inc., 22-0909 (D. Del.) July 7, 2022 Hon. Maryellen Noreika Envarsus XR® (tacrolimus extended-release tablets) 8,685,998
9,549,918
10,166,190
10,864,199
11,110,081
11,123,331
Takeda Pharms. U.S.A., Inc. v. Sun Pharm. Indus. Ltd., 22-0911 (D. Del.) July 7, 2022 Hon. Richard G. Andrews Mydayis® (mixed salts of a single-entity amphetamine product extended-release capsules) 8,846,100
9,173,857
Purdue Pharma L.P. v. Accord Healthcare Inc., 22-0913 (D. Del.) July 8, 2022 Hon. Richard G. Andrews OxyContin® (oxycodone HCl extended-release tablets) 11,304,908
11,304,909
Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 22-4499 (D.N.J.) July 8, 2022 Hon. John Michael Vazquez Xtandi® (enzalutamide tablets) 7,709,517
Duchesnay Inc. v. Alkem Labs. Ltd., 22-0917 (D. Del.) July 11, 2022 Hon. Colm F. Connolly Bonjesta® (doxylamine succinate / pyridoxine HCl extended-release tablets) 9,089,489
9,375,404
9,526,703
9,937,132
Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0936 (D. Del.) July 14, 2022 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution injection) 7,762,994
8,114,833
9,265,893
Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0937 (D. Del.) July 14, 2022 Hon. Colm F. Connolly Saxenda® (liraglutide recombinant solution injection) 7,762,994
8,114,833
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
9,968,659
10,220,155
10,357,616
10,376,652
11,097,063
11,311,679
RE 46,363
Azurity Pharms., Inc. v. Alkem Labs. Ltd., 22-0940 (D. Del.) July 15, 2022 Hon. Maryellen Noreika Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 7,157,584
7,572,920
9,066,936
9,169,238
9,387,249
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 22-0941 (D. Del.) July 15, 2022 Hon. Maryellen Noreika Xyrem® (sodium oxybate oral solution) 8,731,963
Horizon Medicines LLC v. Aleor Dermaceuticals Ltd., 22-0944 (D. Del.) July 18, 2022 Vacant Judgeship (2022) Pennsaid® 2% (diclofenac sodium topical solution) 9,066,913
Exelixix, Inc. v. MSN Labs. Private Ltd., 22-0945 (D. Del.) July 18, 2022 Hon. Richard G. Andrews Cabometyx® (cabozantinib tablets) 11,298,349
Helsinn Healthcare S.A. v. Gland Pharma Ltd., 22-4635 (D.N.J.) July 18, 2022 Hon. Zahid N. Quraishi Akynzeo® (fosnetupitant chloride HCl / palonosetron HCl injection) 8,426,450
8,895,586
9,186,357
9,403,772
9,908,907
10,208,073
10,624,911
10,717,721
10,828,297
11,312,698
Horizon Therapeutics, LLC v. Taro Pharm. Indus. Ltd., 22-4663 (D.N.J.) July 20, 2022 Hon. Christine P. O’Hearn 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
Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 22-4670 (D.N.J.) July 21, 2022 Hon. Stanley R. Chesler Duobrii® (halobetasol propionate / tazarotene lotion) 8,809,307
10,478,502
10,251,895
10,426,787
Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 22-0965 (D. Del.) July 22, 2022 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 11,311,532
Vertex Pharms. Inc. v. Lupin Ltd., 22-0966 (D. Del.) July 22, 2022 Hon. Richard G. Andrews Kalydeco® (ivacaftor oral granules) 8,883,206 
10,272,046
10,646,481
11,147,770
Supernus Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 22-4705 (D.N.J.) July 22 2022 Hon. Georgette Castner 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
Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 22-6225 (S.D.N.Y.) July 22, 2022 Hon. John P. Cronan Duobrii® (halobetasol propionate / tazarotene lotion) 8,809,307
10,478,502
10,251,895
10,426,787
Covis Pharma Gmbh v. Eugia Pharma Specialties Ltd., 22-0971 (D. Del.) July 25, 2022 Hon. Kent A. Jordan Makena® Auto-Injector (hydroxyprogesterone caproate) 11,304,962
Merck KGaA v. Accord Healthcare, Inc., 22-0974 (D. Del.) July 25, 2022 Hon. Gregory B. Williams Mavenclad® (cladribine tablets) 7,713,947
8,377,903
Rigel Pharms., Inc. v. Annora Pharma Private Ltd., 22-4732 (D.N.J.) July 25, 2022 Hon. Evelyn Padin Tavalisse® (fostamatinib disodium hexahydrate tablets) 7,449,458
8,263,122
8,652,492
8,771,648
8,951,504
Hope Medical Enterprises, Inc. v. Accord Healthcare, Inc., 22-0978 (D. Del.) July 26, 2022 Hon. Richard G. Andrews sodium thiosulfate injection 8,496,973
9,345,724
9,585,912
10,479,686
Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC, 22-0985 (D. Del.) July 27, 2022 Hon. Colm F. Connolly Cinvanti® (aprepitant injection) 9,561,229
9,808,465
9,974,742
9,974,793
9,974,794
10,500,208
10,624,850
10,953,018
11,173,118
Bayer Pharma AG v. Mylan Pharms. Inc., 22-0063 (N.D.W.V.) Aug. 5, 2022 Hon. John Preston Bailey Xarelto® (rivaroxaban tablets) 10,828,310
Novartis Pharms. Corp. v. Ingenus Pharms., LLC, 22-1045 (D. Del.) Aug. 9, 2022 Hon. Maryellen Noreika Xiidra® (lifitegrast ophthalmic solution) 8,084,047
8,168,655
8,367,701
8,592,450
8,927,574
9,085,553
9,353,088
9,447,077
9,890,141
11,058,677
ZS Pharma, Inc. v. Lupin Ltd., 22-1055 (D. Del.) Aug. 10, 2022 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate oral suspension) 8,802,152
8,808,750
8,877,255
9,592,253
9,844,567
9,861,658
9,913,860
10,300,087
10,335,432
10,398,730
10,413,569
10,695,365
Neurocrine Biosciences, Inc. v. Lupin Ltd., 22-1061 (D. Del.) Aug. 11, 2022 Hon. Maryellen Noreika Ingrezza® (valbenazine tosylate capsules) 11,311,532
Merck Sharp & Dohme LLC v. Prinston Pharm. Inc., 22-1070 (D. Del.) Aug. 15, 2022 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Rigel Pharms., Inc. v. Servier Pharms. LLC, IPR2022-01423 Aug. 15, 2022 N/A Idhifa® (enasidenib mesylate tablets) Tibsovo® (ivosidenib tablets) 10,610,125
ZS Pharma, Inc. v. Alkem Labs. Ltd., 22-1096 (D. Del.) Aug. 22, 2022 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate oral suspension) 8,877,255
9,592,253
9,913,860
10,300,087
10,695,365
ZS Pharma, Inc. v. Ascent Pharms. Inc., 22-1099 (D. Del.) Aug. 22, 2022 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate oral suspension) 8,802,152
8,808,750
8,877,255
9,592,253
9,844,567
9,861,658
9,913,860
10,300,087
10,335,432
10,398,730
10,413,569
10,695,365
ZS Pharma, Inc. v. Macleods Pharms. Ltd., 22-1100 (D. Del.) Aug. 22, 2022 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate oral suspension) 8,877,255
9,592,253
9,913,860
10,300,087
10,695,365
ZS Pharma, Inc. v. Sandoz Inc., 22-1101 (D. Del.) Aug. 22, 2022 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate oral suspension) 8,802,152
8,808,750
8,877,255
9,592,253
9,844,567
9,861,658
9,913,860
10,300,087
10,335,432
10,398,730
10,413,569
10,695,365
Boehringer Ingelheim Pharms. Inc. v. Dr. Reddy’s Labs. Ltd., 22-1102 (D. Del.) Aug. 22, 2022 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 11,090,323
Eli Lilly & Co. v. Aurobindo Pharma Ltd., 22-1114 (D. Del.) Aug. 24, 2022 Hon. Colm F. Connolly Olumiant® (baricitinib tablets) 8,158,616
8,420,629
Eli Lilly & Co. v. MSN Labs. Private Ltd., 22-1115 (D. Del.) Aug. 24, 2022 Hon. Colm F. Connolly Olumiant® (baricitinib tablets) 8,158,616
8,420,629
Neurocrine Biosciences, Inc. v. Sandoz Int’l GmbH, 22-1124 (D. Del.) Aug. 26, 2022 Hon. Maryellen Noreika Ingrezza® (valbenazine tosylate capsules) 8,039,627
8,357,697
11,311,532
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1125 (D. Del.) Aug. 26, 2022 Hon. Colm F. Connolly Abilify Maintena® (aripiprazole extended-release injection) 11,344,547
Bausch Health Ireland Ltd. v. Mylan Pharms. Inc., 22-0085 (N.D.W.V.) Sep. 1, 2022 Hon. Thomas S. Kleeh Trulance® (plecanatide tablets) 11,142,549
11,319,346
Galderma Labs., L.P. v. Prinston Pharm., Inc., 22-1166 (D. Del.) Sep. 2, 2022 Hon. Stephanie Bibas Oracea® (doxycycline capsules) 7,749,532
8,206,740
Exelixis, Inc. v. Teva Pharm. Industries Ltd., 22-1168 (D. Del.) Sep. 2, 2022 Hon. Richard G. Andrews Cabometyx® (cabozantinib tablets) 11,298,349
Merck Sharp & Dohme LLC v. Gland Pharma Ltd., 22-5461 (D.N.J.) Sep. 8, 2022 Hon. Julien Xavier Neals Noxafil® (posaconazole injection) 9,023,790
9,358,297
Invagen Pharms., Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-01515 (PTAB) Sep. 8, 2022 N/A Xarelto® (rivaroxaban tablets) 10,828,310
Bayer Intellectual Property GmbH v. USV Private Ltd., 22-5485 (D.N.J.) Sep. 9, 2022 Hon. Evelyn Padin Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-0089 (N.D.W.V.) Sep. 9, 2022 Hon. Thomas S. Kleeh Abilify Maintena® (aripiprazole extended-release injection) 11,344,547
Teva Pharms. USA, Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-01513 (PTAB) Sep. 9, 2022 N/A Xarelto® (rivaroxaban tablets) 10,828,310
BioDelivery Sciences International, Inc. v. Chemo Research, S.L., 22-1196 (D. Del.) Sept. 12, 2022 Hon. Colm F. Connolly Belbuca® (buprenorphine buccal film) 8,147,866
9,655,843
9,901,539
AstraZeneca AB v. Annora Pharma Private Ltd., 22-1209 (D. Del.) Sept. 15, 2022 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
Eisai R&D Management Co., Ltd. v. Long Grove Pharms., LLC, 22-1211 (D. Del.) Sept. 15, 2022 Hon. Colm F. Connolly Halaven® (eribulin mesylate injection) RE 46,965
Intercept Pharms., Inc. v. Zenara Pharma Private Ltd., 22-1215 (D. Del.) Sept. 16, 2022 Hon. Maryellen Noreika Ocaliva® (obeticholic acid tablets) 9,238,673
10,047,117
10,052,337
10,174,073
10,751,349
10,758,549
AstraZeneca AB v. Alembic Pharms. Ltd., 22-1216 (D. Del.) Sept. 16, 2022 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
Salix Pharms., Inc. v. Zydus Pharms. (USA), Inc., 22-5589 (D.N.J.) Sept. 16, 2022 Hon. Julien Xavier Neals Colazal® (balsalazide disodium capsules) 7,452,872
7,625,884
8,497,256
Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 22-5599 (D.N.J.) Sept. 16, 2022 Hon. Evelyn Padin Xarelto® (rivaroxaban tablets) 9,539,218
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1226 (D. Del.) Sep. 20, 2022 Hon. Colm F. Connolly Abilify Maintena® (aripiprazole extended-release injection) 11,400,087
Radius Health, Inc. v. Orbicular Pharm. Techs. Pvt. Ltd., 22-11546 (D. Mass.) Sep. 20, 2022 Hon. Richard G. Stearns Tymlos® (abaloparatide injection) 7,803,770
8,148,333
8,748,382
10,996,208
11,255,842
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., 22-1227 (D. Del.) Sep. 21, 2022 Hon. Maryellen Noreika Velphoro® (sucroferric oxyhydroxide chewable tablets) 11,446,252
Zogenix, Inc. v. Apotex Inc., 22-1232 (D. Del.) Sep. 21, 2022 Hon. Richard G. Andrews Fintepla® (fenfluramine HCl oral solution) 11,406,606
Nexus Pharms., Inc. v. Exela Pharma Sciences, LLC, 22-1233 (D. Del.) Sep. 21, 2022 Hon. Gregory B. Williams Akovaz® (ephedrine sulfate for injection) 11,426,369
Array Biopharma Inc. v. Eugia Pharma Specialities Ltd., 22-1236 (D. Del.) Sep. 22, 2022 Hon. Maryellen Noreika Braftovi® (encorafenib capsules) 9,474,754
Gilead Sciences, Inc. v. Natco Pharma Ltd., 22-1259 (D. Del.) Sep. 23, 2022 Hon. Richard G. Andrews Zydelig® (idelalisib tablets) 9,492,449
Nexus Pharms., Inc. v. Nevakar, Inc., 22-5683 (D.N.J.) Sept. 23, 2022 Hon. Renee Marie Bumb Emerphed® (ephedrine sulfate for injection) 11,426,369
Otsuka Pharm. Co., Ltd. v. Zenara Pharma Pvt. Ltd., 22-1269 (D. Del.) Sep. 27, 2022 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) 7,888,362
RE 48,059
8,349,840
8,618,109
9,839,637
10,307,419
Bial-Portela & Ca S.A. v. Aurobindo Pharma Ltd., 22-1270 (D. Del.) Sep. 27, 2022 Hon. Colm F. Connolly Aptiom® (eslicarbazepine acetate tablets) 11,364,247
Array Biopharma Inc. v. Alembic Pharms. Ltd., 22-1277 (D. Del.) Sep. 28, 2022 Hon. Gregory B. Williams Mektovi® (binimetinib tablets) 9,314,464
9,850,229
10,005,761
9,562,016
9,598,376
9,980,944
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA), Inc., 22-1291 (D. Del.) Sep. 30, 2022 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 11,311,532
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA), Inc., 22-5830 (D.N.J.) Sep. 30, 2022 Hon. Zahid N. Quraishi Ingrezza® (valbenazine capsules) 11,311,532

Oren D. Langer

Partner

Managing Partner, New York Office

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