New ANDA Cases

Spring 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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).
Celgene Corp. v. Mylan Pharms. Inc., 20-0003 (N.D.W.V.) Jan. 3, 2020 Hon. Irene M. Keeley Revlimid® (lenalidomide capsules) 7,189,740
7,465,800
7,855,217
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Exela Pharma Sciences, LLC v. Avadel Legacy Pharms., LLC, 20-0024 (D. Del.) Jan. 7, 2020 Hon. Maryellen Noreika Elcys® (cysteine HCl for injection) Nouress™ (cysteine HCl for injection) 10,478,453
Celgene Corp. v. Aurobindo Pharma Ltd., 20-0315 (D.N.J.) Jan. 8, 2020 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
7,968,569
8,530,498
8,648,095
9,101,621
9,101,622
Almirall, LLC v. Zydus Pharms. (USA) Inc., 20-0343 (D.N.J.) Jan. 9, 2020 Hon. Freda L. Wolfson Aczone® (dapsone gel) 9,517,219
Almirall, LLC v. Mylan Pharms. Inc., 20-0006 (N.D.W.V.) Jan. 9, 2020 Hon. Irene M. Keeley Aczone® (dapsone gel) 9,517,219
Amgen Inc. v. Torrent Pharma Inc., 20-0065 (D. Del.) Jan. 16, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 20-0534 (D.N.J.) Jan. 16, 2020 Hon. Claire C. Cecchi Dificid® (fidaxomicin tablets) 7,906,489
8,586,551
7,378,508
7,863,249
8,859,510
Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 20-0074 (D. Del.) Jan. 17, 2020 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 8,101,659
8,796,331
8,877,938
9,388,134
Amgen Inc. v. Zydus Pharms. (USA) Inc., 20-0075 (D. Del.) Jan. 17, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 20-20217 (S.D. Fla.) Jan. 17, 2020 Hon. Ursula Ungaro Dificid® (fidaxomicin tablets) 7,906,489
8,586,551
7,378,508
7,863,249
8,859,510
Vanda Pharms. Inc. v. Apotex Inc., 20-0083 (D. Del.) Jan. 21, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,449,176
Amgen Inc. v. Zydus Pharms. (USA) Inc., 20-0678 (D.N.J.) Jan. 21, 2020 Hon. Freda L. Wolfson Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 20-0093 (D. Del.) Jan. 22, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,449,176
Amgen Inc. v. Bionpharma, Inc., 20-0105 (D. Del.) Jan. 23, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Relypsa, Inc. v. Alkem Labs. Ltd., 20-0106 (D. Del.) Jan. 23, 2020 Hon. Maryellen Noreika Veltassa® (patiromer sorbitex calcium powder for oral suspension) 8,337,824
9,492,476
9,925,212
Merck Sharp & Dohme Corp. v. Sandoz Inc., 20-0783 (D.N.J.) Jan. 23, 2020 Hon. Brian R. Martinotti Noxafil® (posaconazole oral suspension) 8,263,600
Janssen Products, L.P. v. Zydus Pharms. (USA) Inc., 20-0787 (D.N.J.) Jan. 23, 2020 Hon. Freda L. Wolfson Prezista® (darunavir tablets) 7,700,645
8,518,987
7,126,015
7,595,408
Amgen Inc. v. Annora Pharma Private Ltd., 20-0122 (D. Del.) Jan. 24, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Amgen Inc. v. Centaur Pharms. Private Ltd., 20-0123 (D. Del.) Jan. 24, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Jan. 28, 2020 Hon. Leonard P. Stark Gilenya® (fingolimod capsules) 10,543,179
Sucampo Gmbh v. Zydus Pharms. (USA) Inc., 20-0936 (D.N.J.) Jan. 28, 2020 Hon. Freda L. Wolfson Amitiza® (lubiprostone capsules) 7,795,312
8,026,393
8,338,639
8,779,187
8,748,481
Amgen Inc. v. MSN Pharms., Inc., 20-0137 (D. Del.) Jan. 29, 2020 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Pfizer Inc. v. Viwit Pharm. Co., Ltd., 20-0160 (D. Del.) Jan. 31, 2020 Hon. Colm F. Connolly Chantix® (varenicline tartrate tablets) 6,410,550
6,890,927
7,265,119
Silvergate Pharms., Inc. v. CMP Development LLC, 20-0161 (D. Del.) Jan. 31, 2020 Hon. Leonard P. Stark Qbrelis® (Lisinopril oral solution) 9,463,183
9,616,096
9,814,751
10,039,800
10,265,370
10,406,199
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00368 (PTAB) Jan. 31, 2020 N/A Dymista® (azelastine HCl / fluticasone propionate metered spray) 8,163,723
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00369 (PTAB) Jan. 31, 2020 N/A Dymista® (azelastine HCl / fluticasone propionate metered spray) 8,168,620
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00370 (PTAB) Jan. 31, 2020 N/A Dymista® (azelastine HCl / fluticasone propionate metered spray) 9,259,428
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00371 (PTAB) Jan. 31, 2020 N/A Dymista® (azelastine HCl / fluticasone propionate metered spray) 9,901,585
Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 20-0019 (N.D.W.V.) Feb. 5, 2020 Hon. Irene M. Keeley Tradjenta® (linagliptin tablets) 9,486,526
Boehringer Ingelheim Pharms. Inc. v. Aurobindo Pharma Ltd., 20-0023 (N.D.W.V.) Feb. 5, 2020 Hon. John Preston Bailey Tradjenta® (linagliptin tablets) 9,486,526
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Feb. 7, 2020 Hon. Maryellen Noreika Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) Odefsey® (emtricitabine / rilpivirine / tenofovir alafenamide tablets) 7,390,791
7,803,788
8,754,065
9,296,769
American Regent, Inc. v. Pharmacosmos Therapeutics Inc., 20-1350 (D.N.J.) Feb. 7, 2020 Hon. Brian R. Martinotti Monoferric® (ferric derisomaltose for injection) 8,431,549
10,478,450
Allergan Sales, LLC v. Breckenridge Pharm., Inc., 20-0199 (D. Del.) Feb. 10, 2020 Hon. Mitchell S. Goldberg Saphris® (asenapine maleate sublingual tablets) 5,763,476
AstraZeneca AB v. Alembic Pharms. Ltd., 20-0202 (D. Del.) Feb. 11, 2020 Hon. Richard G. Andrews Tagrisso® (osimertinib mesylate tablets) 10,183,020
Vifor (Int’l) AG v. Mylan Labs. Ltd., 20-1647 (D.N.J.) Feb. 14, 2020 Hon. Freda L. Wolfson Injectafer® (ferric carboxymaltose for injection) 10,519,252
Vifor (Int’l) AG v. Sandoz Inc., 20-1649 (D.N.J.) Feb. 14, 2020 Hon. Freda L. Wolfson Injectafer® (ferric carboxymaltose for injection) 10,519,252
Vanda Pharms. Inc. v. MSN Pharms. Inc., 20-0235 (D. Del.) Feb. 19, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,376,487
Astellas US LLC v. Int’l Medication Systems, Ltd., 20-0273 (D. Del.) Feb. 25, 2020 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 20-0277 (D. Del.) Feb. 25, 2020 Hon. Colm F. Connolly Glyxambi® (empagliflozin / linagliptin tablets) 10,258,637
Millennium Pharms., Inc. v. Sun Pharm. Indus. Ltd., 20-0289 (D. Del.) Feb. 27, 2020 Hon. Colm F. Connolly Ninlaro® (ixazomib citrate capsules) 7,442,830
8,859,504
9,175,017
ViiV Healthcare Co. v. Lupin Ltd., 20-0293 (D. Del.) Feb. 28, 2020 Hon. Mitchell S. Goldberg Juluca® (dolutegravir sodium / rilpivirine HCl tablets) 9,242,986
10,426,780
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-0300 (D. Del.) Feb. 28, 2020 Hon. Leonard P. Stark Xeljanz® (tofacitinib citrate tablets) 6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-0301 (D. Del.) Feb. 28, 2020 Hon. Leonard P. Stark Xeljanz XR® (tofacitinib extended-release tablets) 6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-2222 (D.N.J.) Feb. 28, 2020 Hon. Freda L. Wolfson Xeljanz XR® (tofacitinib extended-release tablets) 6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-2227 (D.N.J.) Feb. 28, 2020 Hon. Freda L. Wolfson Xeljanz® (tofacitinib citrate tablets) 6,965,027
7,301,023
RE41,783
Vanda Pharms. Inc. v. MSN Pharms. Inc., 20-0318 (D. Del.) Mar. 3, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,449,176
Takeda Pharms. U.S.A., Inc. v. Alkem Labs. Ltd., 20-0325 (D. Del.) Mar. 3, 2020 Hon. Richard G. Andrews Colcrys® (colchicine tablets)) 7,906,519
7,935,731
8,093,298
7,964,648
8,093,297
7,619,004
7,601,758
7,820,681
7,915,269
7,964,647
7,981,938
8,093,296
8,097,655
8,415,395
8,415,396
8,440,721
8,440,722
Encore Dermatology Inc. v. Glenmark Pharms. Ltd., 20-2509 (D.N.J.) Mar. 6, 2020 Hon. Kevin McNulty Impoyz® (clobetasol propionate cream) 9,956,231
Astellas US LLC v. Gland Pharma Ltd., 20-0347 (D. Del.) Mar. 9, 2020 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 20-2576 (D.N.J.) Mar. 10, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Celgene Corp. v. Apotex Inc., 20-2593 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Breckenridge Pharm., Inc., 20-2597 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Hetero Labs Ltd., 20-2601 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Aurobindo Pharma Ltd., 20-2606 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 20-2607 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Mylan Pharms. Inc., 20-2608 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Celgene Corp. v. Teva Pharms. USA, Inc., 20-2614 (D.N.J.) Mar. 10, 2020 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 10,555,939
Bausch Health US, LLC v. Aleor Dermaceuticals Ltd., 20-2735 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Alkem Labs. Ltd., 20-2737 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Aurobindo Pharma USA Inc., 20-2738 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Amneal Pharms. LLC v. Cubist Pharms. LLC, IPR2020-00193 (PTAB) Nov. 27, 2019 N/A Cubicin RF® (daptomycin for injection) 9,138,456
Bausch Health US, LLC v. KVK-Tech, Inc., 20-2742 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Lupin Ltd., 20-2744 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Strides Pharma Inc., 20-2746 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Taro Pharms. U.S.A., Inc., 20-2747 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Zydus Pharms. (USA) Inc., 20-2748 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Mylan Pharms. Inc., 20-2749 (D.N.J.) Mar. 12, 2020 Hon. Brian R. Martinotti Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Merck Sharp & Dohme B.V. v. Gland Pharma Ltd., 20-2750 (D.N.J.) Mar. 12, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Merck Sharp & Dohme B.V. v. Teva Pharms. USA, Inc., 20-2751 (D.N.J.) Mar. 12, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Braintree Labs., Inc. v. Alkem Labs. Ltd., 20-0362 (D. Del.) Mar. 13, 2020 Hon. Colm F. Connolly Suprep® Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution) 6,946,149
Merck Sharp & Dohme B.V. v. Lupin Ltd., 20-2786 (D.N.J.) Mar. 13, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Merck Sharp & Dohme B.V. v. Mankind Pharma Ltd., 20-2787 (D.N.J.) Mar. 13, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
6,949,527
Bausch Health US, LLC v. Mylan Pharms. Inc., 20-0046 (N.D.W.V.) Mar. 13, 2020 Hon. Irene M. Keeley Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
Exela Pharma Sciences, LLC v. Eton Pharms., Inc., 20-0365 (D. Del.) Mar. 16, 2020 Hon. Maryellen Noreika Elcys® (cysteine HCl for injection) 10,478,453
10,583,155
Merck Sharp & Dohme B.V. v. Fresenius Kabi USA, LLC, 20-2892 (D.N.J.) Mar. 16, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Braintree Labs., Inc. v. Alkem Labs. Ltd., 20-2904 (D.N.J.) Mar. 16, 2020 Hon. Peter G. Sheridan Suprep® Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution) 6,946,149
Merck Sharp & Dohme B.V. v. Dr. Reddy’s Labs., Inc., 20-2909 (D.N.J.) Mar. 16, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Merck Sharp & Dohme B.V. v. Fisiopharma S.R.L., 20-2964 (D.N.J.) Mar. 17, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Merck Sharp & Dohme B.V. v. Sun Pharm. Indus., Inc., 20-3007 (D.N.J.) Mar. 18, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Hoffmann-La Roche, Inc. v. Fresenius Kabi USA, LLC, 20-0394 (D. Del.) 19-Mar-20 Hon. Richard G. Andrews Alcensa® (alectinib HCl capsules) 9,126,931
9,440,922
9,365,514
10,350,214
Merck Sharp & Dohme B.V. v. Zydus Pharms. (USA) Inc., 20-3068 (D.N.J.) Mar. 19, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Merck Sharp & Dohme B.V. v. USV Private Ltd., 20-3072 (D.N.J.) Mar. 19, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Pharmacyclics LLC v. Sun Pharma Global FZE, 20-0403 (D. Del.) Mar. 20, 2020 Hon. Colm F. Connolly Imbruvica® (ibrutinib tablets) 10,478,439
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA, Inc. 20-3102 (D.N.J.) Mar. 20, 2020 Hon. Renee Marie Bumb Invokamet XR® (canagliflozin / metformain HCl extended-release tablets) 7,943,582
8,513,202
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA, Inc. 20-3106 (D.N.J.) Mar. 20, 2020 Hon. Freda L. Wolfson Invokamet XR® (canagliflozin / metformain HCl extended-release tablets) 7,943,788
8,222,219
8,785,403
Merck Sharp & Dohme B.V. v. Aspiro Pharma Ltd., 20-3112 (D.N.J.) Mar. 20, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
6,949,527
Merck Sharp & Dohme B.V. v. Sandoz Inc., 20-3117 (D.N.J.) Mar. 20, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Cubist Pharms. LLC v. Mylan Pharms Inc., 20-3168 (D.N.J.) Mar. 23, 2020 Hon. Brian R. Martinotti Cubicin RF® (daptomycin for injection) 9,138,456
Novartis Pharms. Corp. v. Lupin Atlantis Holdings, S.A., 20-0415 (D. Del.) Mar. 24, 2020 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 8,101,659
8,796,331
8,877,938
9,388,134
Cubist Pharms. LLC v. Mylan Pharms. Inc., 20-0052 (N.D.W.V.) Mar. 24, 2020 Hon. Irene M. Keeley Cubicin RF® (daptomycin for injection) 9,138,456
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 20-3229 (D.N.J.) Mar. 25, 2020 Hon. Michael A. Shipp Sprycel® (dasatinib tablets) 7,491,725
Merck Sharp & Dohme B.V. v. Mylan API US LLC, 20-3270 (D.N.J.) Mar. 25, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Salix Pharms., Ltd. v. Norwich Pharms., Inc., 20-0430 (D. Del.) Mar. 26, 2020 Hon. Richard G. Andrews Xifaxan® (rifaximin tablets) 7,045,620
7,612,199
7,902,206
7,906,542
7,915,275
8,158,644
8,158,781
8,193,196
8,309,569
8,518,949
8,642,573
8,741,904
8,829,017
8,835,452
8,853,231
8,946,252
8,969,398
9,271,968
9,421,195
9,629,828
10,314,828
10,335,397
10,456,384
Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, 20-0431 (D. Del.) Mar. 26, 2020 Hon. Maryellen Noreika Firmagon® (degarelix for injection) 9,579,359
9,415,085
8,841,081
9,877,999
8,828,938
Merck Sharp & Dohme B.V. v. MSN Labs. Private Ltd., 20-3314 (D.N.J.) Mar. 26, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Mallinckrodt Hospital Products IP Ltd. v. Baxter Healthcare Corp., 20-0434 (D. Del.) Mar. 27, 2020 Hon. Leonard P. Stark Ofirmev® (acetaminophen for injection) 9,399,012
9,610,265
9,987,238
10,383,834
6,992,218
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