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).
Novartis Pharms. Corp. v. MSN Pharms. Inc., 21-0981 (D. Del.) 1-Jul-21 Hon. Leonard P. Stark Kisqali® Femara®
Co-pack (ribociclib / letrozole tablets)
8,324,225
8,415,355
8,685,980
8,962,630
9,416,136
AstraZeneca AB v. Alembic Pharms. Ltd., 21-0982 (D. Del.) 1-Jul-21 Hon. Richard G. Andrews Tagrisso® (osimertinib mesylate tablets) 10,183,020
Teva Branded Pharm. Products R&D, Inc. v. Aurobindo Pharma Ltd., 21-13240 (D.N.J.) 1-Jul-21 Hon. Freda L. Wolfson Austedo® (deutetrabenazine tablets) 8,524,733
9,233,959
9,296,739
9,550,780
9,814,708
10,959,996
Teva Branded Pharm. Products R&D, Inc. v. Lupin Ltd., 21-13247 (D.N.J.) 1-Jul-21 Hon. Freda L. Wolfson Austedo® (deutetrabenazine tablets) 9,233,959
9,296,739
9,550,780
9,814,708
Orexo AB v. Sun Pharm. Indus. Ltd., 21-13320 (D.N.J.) 2-Jul-21 Hon. Zahid N. Quaraishi Zubsolv® (buprenorphine / naloxone sublingual tablets) 10,874,661
10,946,010
Astellas Pharma Inc. v. Alkem Labs. Ltd., 21-0992 (D. Del.) 6-Jul-21 Hon. Joseph F. Bataillon Myrbetriq®
(mirabegron extended-release tablets)
7,342,117
7,982,049
8,835,474
10,842,780
RE44,872
Bayer Healthcare LLC v. Dr. Reddy’s Labs., Inc., 21-0997 (D. Del.) 7-Jul-21 Hon. Leonard P. Stark Nexavar® (sorafenib tosylate tablets) 9,737,488
Bayer Pharma AG v. Taro Pharm. Indus. Ltd., 21-1000 (D. Del.) 7-Jul-21 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Bayer Pharma AG v. Teva Pharms. USA, Inc., 21-1001 (D. Del.) 7-Jul-21 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Horizon Medicines LLC v. Torrent Pharma Inc., 21-13396 (D.N.J.) 7-Jul-21 Hon. Stanley R. Chesler Duexis® (ibuprofen / famotidine tablets) 8,067,033
8,067,451
8,309,127
8,318,202
8,449,910
8,501,228
Eli Lilly and Co. v. Radius Health, Inc., 21-1003 (D. Del.) 8-Jul-21 Hon. Colm F. Connolly Tymlos® (abaloparatide for injection) Forteo® (teriparatide for injection) 7,517,334
Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., 21-1006 (D. Del.) 9-Jul-21 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Patheon Softgels Inc. v. Strides Pharma Inc., 21-13521 (D.N.J.) 9-Jul-21 Hon. Brian R. Martinotti Naproxen sodium capsules 9,693,978
9,693,979
10,022,344
10,028,925
Nippon Shinyaku Co., Ltd. v. Sarepta Therapeutics, Inc., 21-1015 (D. Del.) 13-Jul-21 Hon. Leonard P. Stark Vyondys® 53 (golodirsen for injection) 10,227,590
10,266,827
10,385,092
10,407,461
10,487,106
10,647,741
10,662,217
10,683,322
9,708,361
9,994,851
Vertex Pharms. Inc. v. Lupin Ltd., 21-1019 (D. Del.) 13-Jul-21 Hon. Richard G. Andrews Kalydeco® (ivacaftor tablets) 10,646,481
Merz Pharms., LLC v. MSN Pharms. Inc., 21-1032 (D. Del.) 15-Jul-21 Hon. Richard G. Andrews Cuvposa® (glycopyrrolate oral solution) 7,638,552
7,816,396
Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc., 21-1033 (D. Del.) 15-Jul-21 Hon. Richard G. Andrews Janumet XR® (metformin HCl / sitagliptin phosphate extended release tablets) 7,326,708
Fresenius Kabi USA, LLC v. Baxter Healthcare Corp., 21-1040 (D. Del.) 16-Jul-21 Hon. Maryellen Noreika Naropin® (ropivacaine HCl injection) 7,828,787
7,857,802
8,118,802
8,162,915
Neurocrine Biosciences, Inc. v. Lupin Ltd., 21-1042 (D. Del.) 16-Jul-21 Hon. Maryellen Noreika Ingrezza® (valbenazine 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
Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 21-1043 (D. Del.) 16-Jul-21 Hon. 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
Merz Pharms., LLC v. MSN Pharms. Inc., 21-13731 (D.N.J.) 16-Jul-21 Hon. Brian R. Martinotti Cuvposa® (glycopyrrolate oral solution) 7,638,552
7,816,396
Bayer Pharma AG v. Mylan Pharms. Inc., 21-0099 (N.D.W.V.) 22-Jul-21 Hon. Irene M. Keeley Xarelto® (rivaroxaban tablets) 10,828,310
Allergan USA, Inc. v. Alkem Labs. Ltd., 21-1061 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Allergan USA, Inc. v. Aurobindo Pharma Ltd., 21-1062 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Allergan USA, Inc. v. Hetero Labs Ltd., 21-1063 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Allergan USA, Inc. v. MSN Labs. Private Ltd., 21-1064 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 21-1065 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Allergan USA, Inc. v. Zydus Pharms. (USA) Inc., 21-1066 (D. Del.) 23-Jul-21 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,007,179
Neurocrine Biosciences, Inc. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1067 (D. Del.) 23-Jul-21 Hon. 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
Eli Lilly and Co. v. Sun Pharm. Indus. Ltd., 21-1092 (D. Del.) 28-Jul-21 Hon. Colm F. Connolly Forteo® (teriparatide for injection) 7,517,334
Supernus Pharms., Inc. v. Torrent Pharms. Ltd., 21-14268 (D.N.J.) 28-Jul-21 Hon. Freda L. Wolfson Trokendi XR® (topiramate extended-release capsues) 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
Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 21-14271 (D.N.J.) 28-Jul-21 Hon. Stanley R. Chesler Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) 8,591,922
8,772,306
8,901,173
9,050,302
9,132,107
9,486,426
10,195,168
10,213,400
10,675,258
10,864,181
Novartis Pharms. Corp. v. MSN Pharms. Inc., 21-1102 (D. Del.) 29-Jul-21 Hon. Leonard P. Stark Kisqali® (ribociclib tablets) 8,324,225
8,415,355
8,685,980
8,962,630
9,416,136
Novartis Pharms. Corp. v. Lupin Inc., 21-1105 (D. Del.) 29-Jul-21 Hon. Leonard P. Stark Rydapt® (midostaurin capsules) 8,575,146
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 21-1106 (D. Del.) 29-Jul-21 Hon. Leonard P. Stark Rydapt® (midostaurin capsules) 7,973,031
Novartis Pharms. Corp. v. Lotus Pharm. Co., Ltd., 21-1107 (D. Del.) 29-Jul-21 Hon. Leonard P. Stark Rydapt® (midostaurin capsules) 7,973,031
8,222,244
8,575,146
AstraZeneca AB v. Torrent Pharms. Ltd., 21-1116 (D. Del.) 30-Jul-21 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-1118 (D. Del.) 30-Jul-21 Hon. 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
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 21-14428 (D.N.J.) 30-Jul-21 Hon. Michael A. Shipp Rydapt® (midostaurin capsules) 7,973,031
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-14447 (D.N.J.) 30-Jul-21 Hon. Kevin McNulty 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
Duchesnay Inc. v. Hetero Labs Ltd., 21-1130 (D. Del.) Aug. 3, 2021 Hon. Leonard P. Stark Osphena® (ospemifene tablets) 6,245,819
8,236,861
Jazz Pharms., Inc. v. Avadel Pharms., plc, 21-1138 (D. Del.) Aug. 4, 2021 Hon. Maryellen Noreika Xyrem® (sodium oxybate oral solution) 11,077,079
Astellas Pharma Inc. v. Apotex Inc., 21-1141 (D. Del.) Aug. 5, 2021 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Janssen Products, L.P. v. MSN Pharms. Inc., 21-14622 (D.N.J.) Aug. 5, 2021 Hon. Zahid N. Quraishi Yondelis® (trabectedin for injection) 8,895,557
7,420,051
Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 21-1148 (D. Del.) Aug. 6, 2021 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 10,993,941
Vyne Therapeutics Inc. v. Padagis Israel Pharms. Ltd., 21-1152 (D. Del.) Aug. 9, 2021 Hon. Colm F. Connolly Amzeeq® (minocycline topical foam) 8,865,139
8,945,516
8,992,896
9,675,700
10,086,080
10,137,200
10,213,512
10,265,404
10,517,882
10,821,187
10,398,641
10,849,847
Janssen Pharms., Inc. v. Mylan Labs. Ltd., 21-15137 (D.N.J.) Aug. 11, 2021 Hon. Zahid N. Quraishi Invega Trinza® (paliperidone palmitate injection) 10,143,693
Merck Sharp & Dohme Corp. v. MSN Pharms. Inc., 21-1172 (D. Del.) Aug. 12, 2021 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate) Janumet® (metformin HCl / sitagliptin phosphate) 7,326,708
Merck Sharp & Dohme Corp. v. Laurus Labs Ltd., 21-1173 (D. Del.) Aug. 12, 2021 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate) 7,326,708
Pfizer Inc. v. Natco Pharma, Inc., 21-1179 (D. Del.) Aug. 16, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) RE47,739
10,723,730
Biomarin Pharm. Inc. v. Teva Pharms., Inc., 21-15392 (D.N.J.) Aug. 16, 2021 Hon. Esther Salas 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
Nexus Pharms., Inc. v. Nevakar, Inc., 21-15524 (D.N.J.) Aug. 17, 2021 Hon. Renee Marie Bumb Emerphed® (ephedrine sulfate injection) 11,090,278
10,869,845
Baxter Healthcare Corp. v. Par Sterile Products, LLC, 21-1184 (D. Del.) Aug. 18, 2021 Hon. Unassigned Norepinephrine bitartrate in 5% dextrose injection 10,159,657
10,226,436
10,420,735
10,471,026
10,568,850
10,646,458
Endo Ventures Ltd. v. Baxter Healthcare Corp., 21-1186 (D. Del.) Aug. 18, 2021 Hon. Unassigned Norepinephrine bitartrate in 5% dextrose injection 10,226,436
10,420,735
10,471,026
10,568,850
10,646,458
Tolmar Therapeutics, Inc. v. Foresee Pharms. Co., Ltd., 21-15782 (D.N.J.) Aug. 20, 2021 Hon. Julien Xavier Neals Camcevi® (leuprolide for injection) 8,470,359
UCB Inc. v. Cipla Ltd., 21-1229 (D. Del.) Aug. 26, 2021 Hon. Colm F. Connolly Nayzilam® (midazolam nasal spray) 8,217,033
8,809,322
9,289,432
9,687,495
Zogenix, Inc. v. Apotex Inc., 21-1252 (D. Del.) Aug. 30, 2021 Hon. Colm F. Connolly Fintepla® (fenfluramine oral solution) 10,603,290
10,452,815
Eagle Pharms., Inc. v. Slayback Pharma LLC, 21-1256 (D. Del.) Aug. 31, 2021 Hon. Colm F. Connolly Belrapzo® (bendamustine HCl injection) 11,103,483
Astellas US LLC v. Aurobindo Pharma Ltd., 21-1269 (D. Del.) Sept. 3, 2021 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
Apotex Inc. v. Auspex Pharms., Inc., IPR2021-01507 (PTAB) Sept. 8, 2021 N/A Austedo® (deutetrabenazine tablets) 8,524,733
AstraZeneca AB v. Changzhou Pharm. Factory, 21-1284 (D. Del.) Sept. 10, 2021 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 8,425,934
Supernus Pharms., Inc. v. Lupin Ltd., 21-1293 (D. Del.) Sept. 10, 2021 Hon. Maryellen Noreika 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 & Lomb, Inc. v. Slayback Pharma LLC, 21-16766 (D.N.J.) Sept. 10, 2021 Hon. Michael A. Shipp Lumify® (brimonidine tartrate ophthalmic solution) 8,293,742
9,259,425
Supernus Pharms., Inc. v. Zydus Pharms. (USA) Inc., 21-17104 (D.N.J.) Sept. 17, 2021 Hon. Freda L. Wolfson 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. Zydus Pharms. (USA) Inc., 21-7795 (S.D.N.Y.) Sept. 17, 2021 Hon. Jed S. Rakoff 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
Novartis Pharms. Corp. v. Alkem Labs. Ltd., 21-1330 (D. Del.) Sept. 20, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,096,918
Puma Biotechnology, Inc. v. AstraZeneca Pharms. LP, 21-1338 (D. Del.) Sept. 22, 2021 Hon. Colm F. Connolly Tagrisso® (osimertinib tablets) 10,603,314
10,596,162
Almirall, LLC v. Aleor Dermaceuticals Ltd., 21-17449 (D.N.J.) Sept. 23, 2021 Hon. Madeline Cox Arleo Aczone® (dapsone gel) 9,517,219
Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1347 (D. Del.) Sept. 24, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 9,517,226
9,937,143
Anacor Pharms., Inc. v. Alkem Labs. Ltd., 21-1348 (D. Del.) Sept. 24, 2021 Hon. Colm F. Connolly Eucrisa® (crisaborole ointment) 8,039,451
8,168,614
8,501,712
9,682,092
Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-1349 (D. Del.) Sept. 24, 2021 Hon. Colm F. Connolly Eucrisa® (crisaborole ointment) 8,039,451
8,168,614
8,501,712
9,682,092
Anacor Pharms., Inc. v. Macleods Pharms. Ltd., 21-1350 (D. Del.) Sept. 24, 2021 Hon. Colm F. Connolly Eucrisa® (crisaborole ointment) 8,039,451
8,168,614
8,501,712
9,682,092
Anacor Pharms., Inc. v. Padagis Israel Pharms. Ltd., 21-1351 (D. Del.) Sept. 24, 2021 Hon. Colm F. Connolly Eucrisa® (crisaborole ointment) 8,168,614
8,501,712
9,682,092
Anacor Pharms., Inc. v. Teva Pharms. Development, Inc., 21-1353 (D. Del.) Sept. 24, 2021 Hon. Colm F. Connolly Eucrisa® (crisaborole ointment) 8,168,614
8,501,712
9,682,092
Medicure Int’l, Inc. v. Aurobindo Pharma Ltd., 21-17534 (D.N.J.) Sept. 24, 2021 Hon. Kevin McNulty Aggrastat® (tirofiban HCl injection) 6,770,660
Pfizer Inc. v. Apotex Inc., 21-1402 (D. Del.) Sept. 30, 2021 Hon. Colm F. Connolly Chantix® (varenicline tartrate tablets) 6,890,927
7,265,119
Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-17831 (D.N.J.) Sept. 30, 2021 Hon. Freda L. Wolfson Eucrisa® (crisaborole ointment) 8,039,451
8,168,614
8,501,712
9,682,092
Bristol-Myers Squibb Co. v. Alembic Global Holding SA, 21-17926 (D.N.J.) Sept. 30, 2021 Hon. Kevin McNulty Sprycel® (dasatinib tablets) 7,491,725
8,680,103
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