New ANDA Cases

Summer 2018

GENERICally Speaking
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
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