New ANDA Cases

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

First 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).
Ferring Pharms. Inc. v. Eugia Pharma Specialties Ltd., 22-0017 (D. Del.) Jan. 4, 2022 Hon. Maryellen Noreika Firmagon® (degarelix for injection) 9,579,359
10,729,739
10,973,870
9,415,085
10,695,398
8,841,081
9,877,999
8,828,938
Novartis Pharms. Corp. v. Alkem Labs. Ltd., 22-0032 (D. Del.) Jan. 7, 2022 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Amgen Inc. v. Aurobindo Pharma Ltd., 22-0037 (D. Del.) Jan. 10, 2022 Hon. Maryellen Noreika Parsabiv® (etelcalcetide injection) 11,162,500
Eagle Pharms., Inc. v. Celerity Pharms., LLC, 22-0042 (D. Del.) Jan. 11, 2022 Hon. Colm F. Connolly Belrapzo® (bendamustine HCl for injection) 11,103,483
Arbor Pharms., LLC v. Alkem Labs. Ltd., 22-0143 (D.N.J.) Jan. 11, 2022 Hon. Karen M. Williams Nymalize® (nimodipine oral solution) 10,342,787
10,576,070
Pfizer Inc. v. Synthon Pharms., Inc., 22-0045 (D. Del.) Jan. 12, 2022 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) 11,065,250
Nexus Pharms., Inc. v. Nephron SC, Inc., 22-0137 (D.S.C.) Jan. 14, 2022 Hon. Mary Geiger Lewis Emerphed® (ephedrine sulfate for injection) 11,090,278
Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 22-0083 (D. Del.) Jan. 21, 2022 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 22-0092 (D. Del.) Jan. 21, 2022 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 11,026,931
11,026,939
11,040,029
Supernus Pharms., Inc. v. Apotex Inc., 22-0322 (D.N.J.) Jan. 24, 2022 Hon. Freda L. Wolfson Oxtellar XR® (oxcarbazepine extended-release tablets) 11,166,960
Sanofi-Aventis U.S. LLC v. Aurobindo Pharma Ltd., 22-0141 (D. Del.) Jan. 31, 2022 Hon. Richard G. Andrews Jevtana® Kit (cabazitaxel injection) 10,583,110
10,716,777
8,927,592
Acerta Pharma B.V. v. Alembic Pharms. Ltd., 22-0154 (D. Del.) Feb. 2, 2022 Hon. Richard G. Andrews Calquence® (acalabrutinib capsules) 9,758,524
10,239,883
9,796,721
10,167,291
10,272,083
Acerta Pharma B.V. v. Natco Pharma Ltd., 22-0155 (D. Del.) Feb. 2, 2022 Hon. Richard G. Andrews Calquence® (acalabrutinib capsules) 9,290,504
9,758,524
10,239,883
9,796,721
10,167,291
10,272,083
Bausch & Lomb, Inc. v. Lupin Ltd., 22-0534 (D.N.J.) Feb. 2, 2022 Hon. Michael A. Shipp Lumify® (brimonidine tartrate ophthalmic solution) 8,293,742
9,259,425
Mylan Pharms. Inc. v. Bayer Pharma Aktiengesellschaft, IPR2022-00517 (PTAB) Feb. 2, 2022 N/A Xarelto® (rivaroxaban tablets) 10,828,310
Dr. Reddy’s Labs., Inc. v. Genentech, Inc., PGR2022-00023 (PTAB) Feb. 3, 2022 N/A Venclexta® (venetoclax tablets) 10,993,942
Pfizer Inc. v. Sun Pharm. Indus. Ltd., 22-0161 (D. Del.) Feb. 4, 2022 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) 11,065,250
Acerta Pharma B.V. v. Cipla Ltd., 22-0162 (D. Del.) Feb. 4, 2022 Hon. Richard G. Andrews Calquence® (acalabrutinib capsules) 9,758,524
10,239,883
9,796,721
10,167,291
10,272,083
Acerta Pharma B.V. v. MSN Pharms. Inc., 22-0163 (D. Del.) Feb. 4, 2022 Hon. Richard G. Andrews Calquence® (acalabrutinib capsules) 9,290,504
9,758,524
10,239,883
9,796,721
10,167,291
10,272,083
Acerta Pharma B.V. v. Sandoz Inc., 22-0164 (D. Del.) Feb. 4, 2022 Hon. Richard G. Andrews Calquence® (acalabrutinib capsules) 9,290,504
9,758,524
10,239,883
9,796,721
10,167,291
10,272,083
Bayer Pharma AG v. Micro Labs Ltd., 22-0165 (D. Del.) Feb. 4, 2022 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Allergan USA, Inc. v. MSN Labs. Private Ltd., 22-0181 (D. Del.) Feb. 9, 2022 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,229,627
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 22-0182 (D. Del.) Feb. 9, 2022 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,229,627
Novartis Pharms. Corp. v. Laurus Labs Ltd., 22-0186 (D. Del.) Feb. 10, 2022 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 22-0718 (D.N.J.) Feb. 10, 2022 Hon. Madeline Cox Arleo Exparel® (bupivacaine liposome injectable suspension) 11,033,495
11,179,336
Pfizer Inc. v. Slayback Pharma LLC, 22-0191 (D. Del.) Feb. 11, 2022 Hon. Leonard P. Stark Xeljanz® (tofacitinib oral solution) RE41,783
Pfizer Inc. v. Teva Pharms. USA, Inc., 22-0192 (D. Del.) Feb. 11, 2022 Hon. Leonard P. Stark Xeljanz® XR (tofacitinib extended-release tablets) 10,639,309
Astellas US LLC v. Curia Missouri, Inc., 22-0199 (D. Del.) Feb. 14, 2022 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 6,403,567
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 22-0210 (D. Del.) Feb. 16, 2022 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) 10,723,730
11,065,250
Janssen Pharms., Inc. v. Accord Healthcare, Inc., 22-0856 (D.N.J.) Feb. 16, 2022 Hon. Claire C. Cecchi Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Fresenius Kabi USA, LLC v. Sintetica S.A., 22-0217 (D. Del.) Feb. 18, 2022 Hon. Maryellen Noreika Naropin® (ropivacaine HCl injection) 8,118,802
Boehringer Ingelheim Pharms. Inc. v. Laurus Labs Ltd., 22-0220 (D. Del.) Feb. 18, 2022 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 11,090,323
Otsuka Pharm. Co., Ltd. v. Teva Pharms. USA, Inc., 22-0221 (D. Del.) Feb. 18, 2022 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) 7,888,362
RE48,059
8,349,840
8,618,109
9,839,637
10,307,419
AstraZeneca AB v. Taro Pharms. U.S.A., Inc., 22-0892 (D.N.J.) Feb. 18, 2022 Hon. Karen M. Williams Brilinta® (ticagrelor tablets) 10,300,065
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 22-0899 (D.N.J.) Feb. 18, 2022 Hon. Renee Marie Bumb Ibrance® (palbociclib tablets) 10,723,730
11,065,250
AstraZeneca AB v. Taro Pharms. U.S.A., Inc., 22-1405 (S.D.N.Y.) Feb. 18, 2022 Hon. Vernon S. Broderick Brilinta® (ticagrelor tablets) 10,300,065
Amgen Inc. v. Aurobindo Pharma Ltd., 22-0227 (D. Del.) Feb. 22, 2022 Hon. Maryellen Noreika Parsabiv® (etelcalcetide injection) 11,162,500
Bausch Health Companies Inc. v. Gland Pharma Ltd., 22-0939 (D.N.J.) Feb. 22, 2022 Hon. Claire C. Cecchi Relistor® (methylnaltrexone bromide injection) 8,247,425
8,420,663
8,552,025
8,822,490
9,180,125
9,492,445
9,669,096
10,376,584
Exelixis, Inc. v. MSN Labs. Private Ltd., 22-0228 (D. Del.) Feb. 23, 2022 Hon. Richard G. Andrews Cabometyx® (cabozantinib (S)-malate tablets) 11,091,439
11,091,440
11,098,015
Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-0964 (D.N.J.) Feb. 23, 2022 Hon. Noel L. Hillman Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Sun Pharm. Indus. Ltd. v. Aurinia Pharms. Inc., IPR2022-00617 (PTAB) Feb. 24, 2022 N/A Lupkynis® (voclosporin capsules) 10,286,036
Journey Medical Corp. v. Teva Pharms., Inc. 22-0288 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Qbrexza® (glycopyrronium cloth) 8,618,160
8,859,610
9,259,414
9,744,105
10,004,717
10,052,267
10,543,192
10,548,875
Novo Nordisk Inc. v. Rio Biopharms. Inc., 22-0294 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 8,129,343
9,132,239
9,457,154
9,687,611
10,335,462
Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc., 22-0295 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 7,762,994
8,114,833
8,129,343
8,536,122
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
10,335,462
10,357,616
10,376,652
11,097,063
RE46,363
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0296 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 9,132,239
10,335,462
Novo Nordisk Inc. v. Zydus Worldwide DMCC., 22-0297 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 9,132,239
10,335,462
Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 22-0298 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 8,129,343
8,920,383
9,132,239
9,457,154
9,687,611
9,775,953
10,220,155
10,335,462
11,097,063
RE46,363
Novo Nordisk Inc. v. Alvogen, Inc., 22-0299 (D. Del.) Mar. 4, 2022 Hon. Colm F. Connolly Ozempic® (semaglutide injection) 8,129,343
8,920,383
9,132,239
9,457,154
9,687,611
9,775,953
10,220,155
10,335,462
11,097,063
RE46,363
Cipla Ltd. v. Boehringer Ingelheim Pharms. Inc., 22-0300 (D. Del.) Mar. 4, 2022 Hon. Maryellen Noreika Ofev® (nintedanib capsules) 9,907,756
10,105,323
10,154,990
6,762,180
7,119,093
Otsuka Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 22-0316 (D. Del.) Mar. 10, 2022 Hon. Richard G. Andrews Samsca® (tolvaptan tablets) 8,501,730
10,905,694
Aerie Pharms., Inc. v. Gland Pharma Ltd., 22-1359 (D.N.J.) Mar. 14, 2022 Hon. Michael A. Shipp Rhopressa® (netarsudil dimesylate ophthalmic solution) 9,415,043
9,931,336
11,185,538
10,588,901
Aerie Pharms., Inc. v. Orbicular Pharm. Technologies, 22-1364 (D.N.J.) Mar. 14, 2022 Hon. Michael A. Shipp Rocklatan® (netarsudil / latanoprost ophthalmic solution) 9,415,043
9,931,336
11,185,538
10,588,901
9,993,470
11,197,853
Aerie Pharms., Inc. v. Micro Labs Ltd., 22-1365 (D.N.J.) Mar. 14, 2022 Hon. Michael A. Shipp Rhopressa® (netarsudil ophthalmic solution) 8,394,826
10,174,017
10,654,844
11,028,081
9,415,043
9,931,336
11,185,538
10,588,901
Horizon Orphan LLC v. Teva Pharms., Inc., 22-1382 (D.N.J.) Mar. 15, 2022 Hon. Renee Marie Bumb Procysbi® (cysteamine bitartrate delayed-release capsules) 8,026,284
9,192,590
9,198,882
9,173,851
9,233,077
10,143,665
Arbor Pharms., LLC v. Saba Ilac Sanayi ve Ticaret AS, 22-0353 (D. Del.) Mar. 18, 2022 Hon. Maryellen Noreika Edarbi® (azilsartan medoxomil tablets) 7,157,584
7,572,920
9,066,936
AstraZeneca AB v. Alkem Labs. Ltd., 22-0354 (D. Del.) Mar. 18, 2022 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) RE46,276
10,300,065
Novo Nordisk Inc. v. Mylan Pharms. Inc., 22-0023 (N.D.W.V.) Mar. 18, 2022 Hon. Irene M. Keeley Ozempic® (semaglutide injection) 8,114,833
8,129,343
8,536,122
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
10,355,462
10,357,616
10,376,652
11,097,063
RE46,363
Mallinckrodt Pharms. Ireland Ltd. v. Zydus Pharms. (USA) Inc., 22-1592 (D.N.J.) Mar. 21, 2022 Hon. Claire C. Cecchi Ofirmev® (acetaminophen injection) 9,399,012
9,610,265
9,987,238
10,383,834
Mylan Pharms. Inc. v. Bausch Health Ireland Ltd., IPR2022-00722 (PTAB) Mar. 21, 2022 N/A Trulance® (plecanatide tablets) 7,041,786
Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 22-0377 (D. Del.) Mar. 23, 2022 Hon. Richard G. Andrews Steglatro® (ertugliflozin tablets) 8,080,580
Merck Sharp & Dohme Corp. v. Hetero Labs Ltd., 22-0378 (D. Del.) Mar. 23, 2022 Vacant Judgeship Steglatro® (ertugliflozin tablets) 8,080,580
Merck Sharp & Dohme Corp. v. Zenara Pharma Private Ltd., 22-0379 (D. Del.) Mar. 23, 2022 Vacant Judgeship Steglatro® (ertugliflozin tablets) 8,080,580
Amgen Inc. v. USV Private Ltd., 22-0387 (D. Del.) Mar. 25, 2022 Hon. Maryellen Noreika Parsabiv® (etelcalcetide injection) 9,820,938
10,344,765
11,162,500
Fresenius Kabi USA, LLC v. Zydus Pharms. (USA) Inc., 22-1702 (D.N.J.) Mar. 25, 2022 Hon. Michael A. Shipp Levothyroxine sodium powder for injection 9,006,289
9,168,238
9,168,239
La Jolla Pharm. Co. v. Gland Pharma Ltd., 22-1754 (D.N.J.) Mar. 29, 2022 Hon. Julien Xavier Neals Giapreza® (angiotensin II acetate injection) 11,219,662
9,220,745
10,028,995
10,493,124
11,096,983
9,572,856
9,867,863
10,335,451
10,500,247
10,548,943
Eisai Co., Ltd. v. Hetero USA Inc., 22-1795 (D.N.J.) Mar. 31, 2022 Hon. Christine P. O’Hearn Banzel® (rufinamide oral suspension) 6,740,669
Fresenius Kabi USA, LLC v. Steriscience PTE Ltd., 22-1810 (D.N.J.) Mar. 31, 2022 Hon. Michael A. Shipp Levothyroxine sodium powder for injection 9,006,289
9,168,238
9,168,239

Oren D. Langer

Partner

Managing Partner, New York Office

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