New ANDA Cases

Summer 2018

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Date Filed Judge Drug Patent No(s).
Indivior Inc. v. Alvogen Pine Brook LLC, 18-5285 (D.N.J.) Apr. 3, 2018 Hon. Kevin McNulty Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) 9,931,305
Indivior Inc. v. Dr. Redy’s Labs., Inc., 18-5288 (D.N.J.) Apr. 3, 2018 Hon. Kevin McNulty Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) 9,931,305
Indivior Inc. v. Par Pharm., Inc., 18-5293 (D.N.J.) Apr. 3, 2018 Hon. Kevin McNulty Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) 9,931,305
Indivior Inc. v. Teva Pharms. USA, Inc., 18-5300 (D.N.J.) Apr. 3, 2018 Hon. Kevin McNulty Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) 9,931,305
Egalet US, Inc. v. Teva Pharms. USA, Inc., 18-0505 (D. Del.) Apr. 4, 2018 Hon. Gregory M. Sleet Arymo® (morphine sulfate extended-release tablets) 9,044,402
Eli Lilly and Co. v. Apotex, Inc., 18-1037 (S.D. Ind.) Apr. 4, 2018 Hon. William T. Lawrence Forteo® (teriparatide for injection) 7,517,334
Eli Lilly and Co. v. Apotex, Inc., 18-0518 (D. Del.) Apr. 5, 2018 Hon. Leonard P. Stark Forteo® (teriparatide for injection) 7,517,334
Senju Pharm. Co., Ltd. v. Amneal Pharms. LLC, 18-5571 (D.N.J.) Apr. 5, 2018 Hon. Brian R. Martinotti Prolensa® (bromfenac ophthalmic solution) 8,129,431
8,669,290
8,754,131
8,871,813
8,927,606
9,144,609
9,517,220
9,561,277
Mylan Pharms. Inc. v. Bristol-Myers Squibb Co., IPR2018-00892 (PTAB) Apr. 5, 2018 N/A Eliquis® (apixaban tablets) 9,326,945
iCeutica Pty Ltd. v. Teva Pharms. USA, Inc., 18-0525 (D. Del.) Apr. 6, 2018 Vacant Judgeship (2017) Vivlodex® (meloxicam capsules) 9,526,734
9,649,318
9,808,468
Dr. Reddy’s Labs. Inc. v. Pozen Inc., IPR2018-00894 (PTAB) Apr. 6, 2018 N/A Vimovo® (esomeprazole magnesium / naproxen delayed-release tablets) 9,220,698
Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 18-5752 (D.N.J.) Apr. 9, 2018 Hon. Jose L. Linares Narcan® (naloxone HCl nasal spray) 9,480,644
9,707,226
Eli Lilly and Co. v. Sunshine Lake Pharma Co., Ltd., 18-5765 (D.N.J.) Apr. 9, 2018 Hon. William H. Walls Cialis® (tadalafil tablets) 6,943,166
Mitsubishi Tanabe Pharma Corp. v. Prinston Pharm. Inc., 18-6112 (D.N.J.) Apr. 11, 2018 Hon. Freda L. Wolfson Invokana® (canagliflozin tablets) 7,943,788
Dr. Reddy’s Labs., Inc. v. GlaxoSmithKline LLC, 18-0548 (D. Del.) Apr. 12, 2018 Hon. Leonard P. Stark Lamictal XR® (lamotrigine extended-release tablets) 8,637,512
9,144,547
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 18-6378 (D.N.J.) Apr. 12, 2018 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 6,315,720
6,561,977
6,755,784
8,315,886
8,626,531
Shire Development LLC v. Impax Labs., Inc., 18-0549 (D. Del.) Apr. 13, 2018 Hon. Richard G. Andrews Mydayis® (dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate extended-release capsules) 6,913,768
8,846,100
9,173,857
IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., 18-0555 (D. Del.) Apr. 13, 2018 Hon. Leonard P. Stark Tirosint® (levothyroxine sodium capsules) 7,691,411
7,723,390
UCB, Inc. v. Apotex Inc., 18-60846 (S.D. Fla.) Apr. 17, 2018 Hon. Marcia G. Cooke Xyzal Allergy 24HR® (levocetirizine dihydrochloride solution) 8,633,194
Acerta Pharma B.V. v. Pharmacyclics LLC, 18-581 (D. Del.) Apr. 18, 2018 Vacant Judgeship (2017) Calquence® (acalabrutinib capsules)
Imbruvica® (ibrutinib capsules)
7,459,554
Biogen Int’l GmbH v. Banner Life Sciences LLC, 18-0582 (D. Del.) Apr. 18, 2018 Hon. Leonard P. Stark Tecfidera® (dimethyl fumarate delayed-release capsules)
Bafiertam® (dimethyl fumarate delayed-release capsules)
7,320,999
8,399,514
UCB, Inc. v. Apotex Inc., 18-3404 (S.D.N.Y.) Apr. 18, 2018 Hon. J. Paul Oetken Xyzal Allergy 24HR® (levocetirizine dihydrochloride solution) 8,633,194
Onyx Therapeutics, Inc. v. Cipla Ltd., 18-0598 (D. Del.) Apr. 20, 2018 Hon. Leonard P. Stark Kyprolis® (carfilzomib for injection) 7,417,042
7,737,112
8,207,125
8,207,126
8,207,127
iCeutica Pty Ltd. v. Novitium Pharma LLC, 18-0599 (D. Del.) Apr. 20, 2018 Vacant Judgeship (2017) Vivlodex® (meloxicam capsules) 9,526,734
9,649,318
9,808,468
Amneal Pharms. LLC v. Alkermes Pharma Ireland Ltd., IPR2018-00943 (PTAB) Apr. 20, 2018 N/A Vivitrol® (naltrexone extended-release suspension) 7,919,499
Eisai Co., Ltd. v. Bionpharma Inc., 18-0618 (D. Del.) Apr. 24, 2018 Hon. Leonard P. Stark Banzel® (rufinamide tablets) 6,740,669
7,750,028
Jazz Pharms., Inc. v. Lupin Ltd., 18-8267 (D.N.J.) Apr. 24, 2018 Hon. Esther Salas Xyrem® (sodium oxybate oral solution) 9,486,426
Biogen Int’l GmbH v. Zydus Pharms. (USA) Inc., 18-0623 (D. Del.) Apr. 25, 2018 Hon. Leonard P. Stark Tecfidera® (dimethyl fumarate delayed-release capsules) 6,509,376
Biogen Int’l GmbH v. Zydus Pharms. (USA) Inc., 18-8323 (D.N.J.) Apr. 25, 2018 Hon. Brian R. Martinotti Tecfidera® (dimethyl fumarate delayed-release capsules) 6,509,376
Celgene Corp. v. Zydus Pharms. (USA) Inc., 18-8519 (D.N.J.) Apr. 27, 2018 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,977,357
8,193,219
8,431,598
Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC, 18-0648 (D. Del.) Apr. 30, 2018 Vacant Judgeship (2017) Riomet® (metformin HCl oral solution) 6,890,957
Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 18-0651 (D. Del.) Apr. 30, 2018 Vacant Judgeship (2017) Hetlioz® (tasimelteon capsules) RE46,604
9,060,995
9,539,234
9,549,913
9,730,910
9,855,241
Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC, 18-2545 (E.D.N.Y.) Apr. 30, 2018 Hon. Joan M. Azrack Riomet® (metformin HCl oral solution) 6,890,957
AstraZeneca AB v. Zydus Pharms. (USA) Inc., 18-0664 (D. Del.) 1-May-18 Hon. Richard G. Andrews Farxiga® (dapagliflozin tablets) 6,414,126
6,515,117
H. Lundbeck A/S v. Sigmapharm Labs., LLC, 18-0671 (D. Del.) 3-May-18 Hon. Leonard P. Stark Trintellix® (vortioxetine hydrobromide tablets) 7,144,884
8,476,279
8,722,684
8,969,355
9,227,946
9,861,630
H. Lundbeck A/S v. Torrent Pharms. Ltd., 18-0672 (D. Del.) 3-May-18 Hon. Leonard P. Stark Trintellix® (vortioxetine hydrobromide tablets) 9,861,630
AstraZeneca AB v. Zydus Pharms. (USA) Inc., 18-8778 (D.N.J.) 3-May-18 Hon. Freda L. Wolfson Farxiga® (dapagliflozin tablets) 6,414,126
6,515,117
H. Lundbeck A/S v. Sigmapharm Labs., LLC, 18-1880 (E.D. Pa.) 4-May-18 Hon. Juan R. Sanchez Trintellix® (vortioxetine hydrobromide tablets) 7,144,884
8,476,279
8,722,684
8,969,355
9,227,946
9,861,630
Vanda Pharms. Inc. v. Apotex Inc., 18-689 (D. Del.) 7-May-18 Vacant Judgeship (2017) Hetlioz® (tasimelteon capsules) RE46,604
9,060,995
9,539,234
9,549,913
9,730,910
9,855,241
Vanda Pharms. Inc. v. MSN Pharms. Inc., 18-690 (D. Del.) 7-May-18 Vacant Judgeship (2017) Hetlioz® (tasimelteon capsules) RE46,604
9,060,995
9,539,234
9,549,913
9,730,910
9,855,241
Noven Pharms., Inc. v. Amneal Pharms. LLC, 18-0699 (D. Del.) 8-May-18 Hon. Leonard P. Stark Minivelle® (estradiol transdermal system) 9,730,900
9,724,310
9,833,419
Celgene Corp. v. Cipla Ltd., 18-8964 (D.N.J.) 8-May-18 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,977,357
8,193,219
8,431,598
Sun Pharm. Indus., Inc. v. Perrigo Co., 18-0703 (D. Del.) 9-May-18 Vacant Judgeship (2017) Ultravate® (halobetasol propionate lotion) 8,962,028
Sun Pharm. Indus., Inc. v. Perrigo Co., 18-0530 (W.D. Mich.) 10-May-18 Hon. Janet T. Neff Ultravate® (halobetasol propionate lotion) 8,962,028
Adamas Pharma, LLC v. Sandoz Inc., 18-9032 (D.N.J.) 10-May-18 Hon. Brian R. Martinotti Gocovri® (amantadine HCl extended-release capsules) 8,389,578
8,796,337
8,889,740
8,895,614
8,895,615
8,895,616
8,895,617
8,895,618
8,741,343
9,867,791
9,867,792
9,867,793
9,877,933
Eli Lilly and Co. v. Amneal Pharms. LLC, 18-9071 (D.N.J.) 10-May-18 Hon. William H. Walls Cialis® (tadalafil tablets) 6,943,166
H. Lundbeck A/S v. Cipla Ltd., 18-0753 (D. Del.) 17-May-18 Hon. Leonard P. Stark Trintellix® (vortioxetine hydrobromide tablets) 9,861,630
Astellas Pharma Inc. v. Eugia Pharma Specialties Ltd., 18-0757 (D. Del.) 17-May-18 Hon. Gregory M. Sleet Xtandi® (enzalutamide capsules) 7,709,517
8,183,274
9,126,941
Noven Pharms., Inc. v. Actavis Labs. UT, Inc., 18-0758 (D. Del.) 17-May-18 Hon. Leonard P. Stark Minivelle® (estradiol transdermal system) 9,730,900
9,724,310
9,833,419
Impax Labs., Inc. v. Actavis Labs FL, Inc., 18-9347 (D.N.J.) 17-May-18 Hon. Stanley R. Chesler Rytary® (levodopa / carbidopa extended-release capsules) 9,901,640
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd., 18-0765 (D. Del.) 18-May-18 Hon. Joseph F. Bataillon Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) 6,642,245
6,703,396
Mylan Technologies, Inc. v. Noven Pharms., Inc., IPR2018-01119 (PTAB) 18-May-18 N/A Minivelle® (estradiol transdermal system) 9,833,419
Bial – Portela & Ca S.A. v. SPH Shanghai Zhongxi Pharm. Co., Ltd., 18-0775 (D. Del.) 21-May-18 Vacant Judgeship (2017) Aptiom® (eslicarbazepine acetate tablets) 5,753,646
8,372,431
9,206,135
9,566,244
9,643,929
9,750,747
9,763,954
H. Lundbeck A/S v. Lupin Ltd., 18-0777 (D. Del.) 21-May-18 Hon. Leonard P. Stark Trintellix® (vortioxetine hydrobromide tablets) 9,861,630
Promius Pharma LLC v. Perrigo UK Finco Ltd Partnership, 18-0219 (E.D. Tex.) 22-May-18 Hon. Robert W. Schroeder, III Sernivo® (betamethasone dipropionate spray) 9,364,485
9,433,630
9,439,911
9,655,907
9,775,851
9,877,974
Promius Pharma LLC v. Perrigo UK Finco Ltd Partnership, 18-1415 (D. Minn.) 23-May-18 Hon. Susan R. Nelson Sernivo® (betamethasone dipropionate spray) 9,439,911
9,655,907
9,775,851
9,877,974
Promius Pharma LLC v. Taro Pharms., Inc, 18-4576 (S.D.N.Y.) 23-May-18 Hon. Alvin K. Hellerstein Sernivo® (betamethasone dipropionate spray) 9,364,485
9,433,630
9,439,911
9,655,907
9,775,851
9,877,974
Janssen Products, L.P. v. Dr. Reddy’s Labs., Inc., 18-9655 (D.N.J.) 24-May-18 Hon. William H. Walls Prezista® (darunavir tablets) 8,518,987
7,126,015
7,595,408
Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, IPR2018-01143 (PTAB) 24-May-18 N/A Xarelto® (rivaroxaban tablets) 9,539,218
Pfizer Inc. v. Apotex, Inc., 18-0795 (D. Del.) 25-May-18 Hon. Leonard P. Stark Inlyta® (axitinib tablets) 8,791,140
Shire Development LLC v. SpecGx LLC, 18-0800 (D. Del.) 25-May-18 Hon. Richard G. Andrews Mydayis® (dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate extended-release capsules) 6,913,768
8,846,100
9,173,857
Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 18-9880 (D.N.J.) 30-May-18 Hon. Jose L. Linares Narcan® (naloxone HCl nasal spray) 9,775,838
Par Pharm., Inc. v. Eagle Pharms. Inc., 18-0823 (D. Del.) 31-May-18 Vacant Judgeship (2017) Vasostrict® (vasopressin injection) 9,375,478
9,687,526
9,744,209
9,744,239
9,750,785
9,937,223
Fresenius Kabi USA, LLC v. Eurohealth Int’l Sarl, 18-0835 (D. Del.) 1-Jun-18 Hon. Leonard P. Stark Dilaudid® (hydromorphone HCl for injection) 9,731,082
9,248,229
Cipla Ltd. v. Eli Lilly and Co., 18-1671 (S.D. Ind.) 1-Jun-18 Hon. Jane Magnus-Stinson Cialis® (tadalafil tablets) 6,821,975
7,182,958
Astellas Pharma Inc. v. Cipla Ltd., 18-0844 (D. Del.) 5-Jun-18 Hon. Richard G. Andrews VESIcare® (solifenacin succinate tablets) 6,017,927
Cipla Ltd. v. Alcon Research, Ltd., IPR2018-01020 (PTAB) 5-Jun-18 N/A Pazeo® (olopatadine HCl ophthalmic solution) 8,791,154
Cipla Ltd. v. Alcon Research, Ltd., IPR2018-01021 (PTAB) 5-Jun-18 N/A Pazeo® (olopatadine HCl ophthalmic solution) 9,533,053
H. Lundbeck A/S v. MSN Labs. Private Ltd., 18-0853 (D. Del.) 7-Jun-18 Hon. Leonard P. Stark Trintellix® (vortioxetine hydrobromide tablets) 9,861,630
Purdue Pharma L.P. v. Ascent Pharms., Inc., 18-0855 (D. Del.) 7-Jun-18 Hon. Richard G. Andrews OxyContin® (oxycodone HCl extended-release tablets) 9,060,976
9,073,933
9,522,919
9,147,533
9,861,582
8,309,060
9,675,610
Teijin Ltd. v. MSN Labs. Private Ltd., 18-0881 (D. Del.) 14-Jun-18 Vacant Judgeship (2017) Uloric® (febuxostat tablets) 7,361,676
8,372,872
9,107,912
Celgene Corp. v. Synthon Pharms. Inc., 18-10775 (D.N.J.) 19-Jun-18 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 8,198,262
8,673,939
8,735,428
8,828,427
Celgene Corp. v. Synthon Pharms. Inc., 18-0540 (M.D.N.C.) 21-Jun-18 Hon. Loretta C. Biggs Pomalyst® (pomalidomide capsules) 8,198,262
8,673,939
8,735,428
8,828,427
Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 18-0932 (D. Del.) 25-Jun-18 Hon. Richard G. Andrews VESIcare® (solifenacin succinate tablets) 6,017,927
Celgene Corp. v. Sandoz Inc., 18-11026 (D.N.J.) 26-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,208,516
7,427,638
7,659,302
7,893,101
8,455,536
8,802,717
9,018,243
9,872,854
Celgene Corp. v. Mankind Pharma Ltd., 18-11081 (D.N.J.) 26-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
7,893,101
Gilead Sciences, Inc. v. Strides Pharma, Inc., 18-11134 (D.N.J.) 27-Jun-18 Hon. Michael A. Shipp Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) 6,642,245
6,703,396
8,592,397
8,716,264
9,457,036
9,744,181
Celgene Corp. v. Torrent Pharms. Ltd., 18-11156 (D.N.J.) 27-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
7,893,101
9,872,854
Celgene Corp. v. Shilpa Medicare Ltd., 18-11157 (D.N.J.) 27-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
7,893,101
9,872,854
Celgene Corp. v. Glenmark Pharms. Ltd., 18-11158 (D.N.J.) 27-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,208,516
7,427,638
7,659,302
7,893,101
8,455,536
8,802,717
9,018,243
9,872,854
Amgen Inc. v. Accord Healthcare, Inc., 18-0956 (D. Del.) 28-Jun-18 Unassigned Judge Sensipar® (cinacalcet HCl tablets) 9,375,405
Celgene Corp. v. Macleods Pharms. Ltd., 18-11212 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
Celgene Corp. v. MSN Labs. Private Ltd., 18-11213 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
Celgene Corp. v. Teva Pharms. USA, Inc., 18-11215 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,208,516
7,427,638
7,659,302
7,893,101
8,455,536
8,802,717
9,018,243
9,872,854
Celgene Corp. v. Prinston Pharm. Inc., 18-11216 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
Celgene Corp. v. Emcure Pharms. Ltd., 18-11218 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
9,872,854
Celgene Corp. v. Aurobindo Pharma Ltd., 18-11219 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,208,516
7,427,638
7,659,302
7,893,101
8,455,536
8,802,717
9,018,243
9,872,854
Celgene Corp. v. Annora Pharma Private Ltd., 18-11220 (D.N.J.) 28-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 7,427,638
9,872,854
Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 18-0972 (D. Del.) 29-Jun-18 Hon. Richard G. Andrews Samsca® (tolvaptan tablets) 8,501,730
Amgen Inc. v. Accord Healthcare, Inc., 18-0575 (M.D.N.C.) 29-Jun-18 Hon. William L. Osteen, Jr. Sensipar® (cinacalcet HCl tablets) 9,375,405
AstraZeneca Pharms. LP v. Apotex Inc., 18-11238 (D.N.J.) 29-Jun-18 Hon. Renee Marie Bumb Faslodex® (fulvestrant for injection) 6,774,122
7,456,160
8,329,680
8,466,139
Celgene Corp. v. Cipla Ltd., 18-11262 (D.N.J.) 29-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,208,516
7,427,638
7,659,302
7,893,101
8,455,536
8,802,717
9,018,243
9,872,854
Celgene Corp. v. Alkem Labs. Ltd., 18-11265 (D.N.J.) 29-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,427,638
7,659,302
7,893,101
8,455,536
9,018,243
Celgene Corp. v. Zydus Pharms. USA, Inc., 18-11267 (D.N.J.) 29-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,427,638
7,659,302
7,893,101
8,455,536
9,018,243
Celgene Corp. v. Unichem Labs., Ltd., 18-11268 (D.N.J.) 29-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,427,638
7,659,302
7,893,101
8,455,536
9,018,243
Celgene Corp. v. Dr. Reddy’s Labs., Inc., 18-11269 (D.N.J.) 29-Jun-18 Hon. Michael A. Shipp Otezla® (apremilast tablets) 6,962,940
7,427,638
7,659,302
7,893,101
8,455,536
9,018,243

Related Publications

September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top