New ANDA Cases

Fall 2015

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Date Filed Judge Drug Patent No(s).
Gilead Sciences, Inc. v. Lupin Pharms., Inc., 15-1956 (D. Md.) July 1, 2015 Hon. J. Frederick Motz Tamiflu® (oseltamivir phosphate capsules) 5,763,483
Otsuka Pharm. Co., Ltd. v. MaCleods Pharms. Ltd., 15-5109 (D.N.J.) July 2, 2015 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets)
8,017,615 
8,580,796
8,642,760 
8,759,350
Dr. Reddy’s Labs., Ltd. v. Helsinn Healthcare S.A., IPR2015-01550 (PTAB) July 3, 2015 N/A Aloxi® (palonosetron hydrochloride for injection) 8,729,094
Dr. Reddy’s Labs., Ltd. v. Helsinn Healthcare S.A., IPR2015-01551 (PTAB) July 3, 2015 N/A Aloxi® (palonosetron hydrochloride for injection) 8,729,094
Dr. Reddy’s Labs., Ltd. v. Helsinn Healthcare S.A., IPR2015-01553 (PTAB) July 3, 2015 N/A Aloxi® (palonosetron hydrochloride for injection) 8,729,094
Dr. Reddy’s Labs., Ltd. v. Helsinn Healthcare S.A., IPR2015-01554 (PTAB) July 3, 2015 N/A Aloxi® (palonosetron hydrochloride for injection) 8,729,094
Eli Lilly and Co. v. Lupin Pharms., Inc., 15-1047 (S.D. Ind.) July 6, 2015 Hon. Sarah Evans Barker Axiron® (testosterone metered transdermal solution)
8,419,307 
8,177,449 
8,435,944 
8,807,861 
8,993,520
Prinston Pharm., Inc. v. Noven Therapeutics, LLC, 15-5308 (D.N.J.) July 7, 2015 Hon. Claire C. Cecchi Brisdelle® (paroxetine mesylate capsules) 8,946,251
Eli Lilly and Co. v. Lupin Pharms., Inc., 15-0877 (E.D. Va.) July 6, 2015 Hon. Anthony J. Trenga Axiron® (testosterone metered transdermal solution)
8,419,307
8,177,449 
8,435,944 
8,807,861 
8,993,520
Celgene Corp. v. Teva Pharms. USA, Inc., 15-0589 (D. Del.) July 10, 2015 Hon. Richard G. Andrews Istodax® (romidepsin for injection)
7,608,280 
7,611,724
R-Tech Ueno, Ltd. v. Apotex, Inc., 15-0592 (D. Del.) July 10, 2015 Hon. Sue L. Robinson Rescula® (unoprostone isopropyl ophthalmic solution)
6,770,675 
6,458,836
Eli Lilly and Co. v. Mylan Labs. Ltd., 15-1083 (S.D. Ind.) July 10, 2015 Hon. Sarah Evans Barker Alimta® (pemetrexed for injection) 7,772,209
Fresenius Kabi USA, LLC v. Cubist Pharms., Inc., IPR2015-01566 (PTAB) July 10, 2015 N/A Cubicin® (daptomycin for injection) 8,129,342
Fresenius Kabi USA, LLC v. Cubist Pharms., Inc., IPR2015-01570 (PTAB) July 10, 2015 N/A Cubicin® (daptomycin for injection) 8,058,238
Fresenius Kabi USA, LLC v. Cubist Pharms., Inc., IPR2015-01571 (PTAB) July 10, 2015 N/A Cubicin® (daptomycin for injection) 8,058,238
Fresenius Kabi USA, LLC v. Cubist Pharms., Inc., IPR2015-01572 (PTAB) July 10, 2015 N/A Cubicin® (daptomycin for injection) 8,058,238
Senju Pharm. Co., Ltd. v. Watson Labs., Inc., 15-5591 (D.N.J.) July 16, 2015 Hon. Jerome B. Simandle Prolensa® (bromfenac ophthalmic solution)
8,129,431 
8,669,290 
8,754,131 
8,871,813 
8,927,606
Gilead Sciences, Inc. v. Sigmapharm Labs., LLC, 15-3950 (E.D. Pa.) July 16, 2015 Hon. Gerald J. Pappert Letairis® (ambrisentan tablets) RE42,462
Meda Pharms Inc. v. Amneal Pharms. LLC, 15-0617 (D. Del.) July 17, 2015 Hon. Gregory M. Sleet Astepro® (azelastine hydrochloride nasal spray)
8,071,073 
8,518,919
Roxane Labs., Inc. v. Novel Labs., Inc., 15-5618 (D.N.J.) July 17, 2015 Hon. Stanley R. Chesler Phoslo® (calcium acetate tablet) 8,563,032
Jazz Pharms., Inc. v. Wockhardt Bio AG, 15-5619 (D.N.J.) July 17, 2015 Hon. Esther Salas Xyrem® (sodium oxybate oral solution)
6,472,431 
6,780,889 
7,262,219 
7,851,506 
8,263,650 
8,324,275 
8,461,203 
7,668,730 
7,765,106 
7,765,107 
7,895,059 
8,457,988 
8,589,182 
8,731,963 
8,772,306 
8,859,619 
8,952,062
Spectrum Pharms., Inc. v. Actavis LLC, 15-1360 (D. Nev.) July 17, 2015 Hon. James C. Mahan Fusilev® (levoleucovorin calcium for injection) 6,500,829
Alcon Research, Ltd. v. Lupin Ltd., 15-0621 (D. Del.) July 20, 2015 Hon. Sue L. Robinson Travatan Z® (travoprost ophthalmic solution)
8,268,299
8,323,630 
8,388,941
United Therapeutics Corp. v. Watson Labs., Inc., 15-5723 (D.N.J.) July 22, 2015 Hon. Peter G. Sheridan Tyvaso® (treprostinil inhalation solution)
6,521,212 
6,756,033 
8,497,393
Alcon Pharms. Ltd. v. Dr. Reddy’s Labs., Inc., 15-5756 (D.N.J.) July 24, 2015 Hon. Peter G. Sheridan Ciprodex® (ciprofloxacin / dexamethasone otic suspension)
6,284,804
6,359,016
Lannett Holdings, Inc. v. AstraZeneca AB, IPR2015-01629 (PTAB) July 28, 2015 N/A Zomig® (zolmitriptan nasal spray) 6,750,237
Lannett Holdings, Inc. v. AstraZeneca AB, IPR2015-01630 (PTAB) July 28, 2015 N/A Zomig® (zolmitriptan nasal spray) 7,220,767
Mylan Pharma Acquisition LTD v. Fresenius Kabi USA, LLC, 15-6700 (N.D. Ill.) July 30, 2015 Hon. Rebecca R. Pallmeyer Ultiva® (remifentanil hydrochloride for Injection) 5,866,591
Janssen Pharmaceutica N.V. v. Fera Pharms., LLC, 15-5997 (S.D.N.Y.) July 30, 2015 Hon. P. Kevin Castel Sporanox® (itraconazole oral solution) 6,407,079
Cosmo Technologies Ltd. v. Lupin Ltd., 15-0669 (D. Del.) July 31, 2015 Hon. Leonard P. Stark Uceris® (budesonide tablets)
7,410,651
RE43,799
Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 15-0670 (D. Del.) July 31, 2015 Hon. Leonard P. Stark Oracea® (doxycycline capsules)
7,211,267 
7,232,572 
8,603,506 
7,749,532 
8,206,740 
8,394,405 
8,394,406 
8,470,364
8,709,478
BTG Int’l Ltd. v. Actavis Labs. FL, Inc., 15-5909 (D.N.J.) July 31, 2015 Hon. Kevin McNulty Zytiga® (abiraterone acetate tablets)
5,604,213
8,822,438
Validus Pharms. LLC v. Aurobindo Pharma Ltd., 15-5912 (D.N.J.) July 31, 2015 Hon. Michael A. Shipp Equetro® (carbamazepine extended-release capsules) 6,977,253
Sawai USA, Inc. v. Nissan Chemical Industries Ltd., IPR2015-01647 (PTAB) July 31, 2015 N/A Livalo® (pitavastatin calcium tablets) 5,856,336
Sawai USA, Inc. v. Nissan Chemical Industries Ltd., IPR2015-01648 (PTAB) July 31, 2015 N/A Livalo® (pitavastatin calcium tablets) 5,856,336
Janssen Biotech, Inc. v. Amneal Pharms. LLC, 15-0679 (D. Del.) Aug. 3, 2015 Hon. Sue L. Robinson Zytiga® (abiraterone acetate tablets) 8,822,438
BTG International Ltd. v. Actavis Labs. FL, Inc., 15-81076 (S.D. Fla.) Aug. 3, 2015 Hon. Donald M. Middlebrooks Zytiga® (abiraterone acetate tablets)
5,604,213
8,822,438
Boehringer Ingelheim Pharms. Inc. v. HEC Pharm Group, 15-5982 (D.N.J.) Aug. 4, 2015 Hon. Peter G. Sheridan
Tradjenta® (linagliptin tablets) 
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
7,407,955 
8,119,648 
8,178,541 
8,673,927 
8,846,695 
8,853,156
Janssen Biotech, Inc. v. Mylan Pharms. Inc., 15-0130 (N.D.W.V.) Aug. 4, 2015 Hon. Irene M. Keeley Zytiga® (abiraterone acetate tablets) 8,822,438
Purdue Pharma L.P. v. Actavis Labs. FL, Inc., 15-0686 (D. Del.) Aug. 5, 2015 Hon. Gregory M. Sleet Hysingla® ER (hydrocodone bitartrate extended-release tablets)
6,733,783
8,361,499 
8,551,520 
8,647,667 
9,023,401 
8,529,948 
8,808,740 
8,309,060
Purdue Pharma L.P. v. Alvogen Pine Brook, Inc., 15-0687 (D. Del.) Aug. 5, 2015 Hon. Gregory M. Sleet Hysingla® ER (hydrocodone bitartrate extended-release tablets)
6,733,783 
8,361,499 
8,551,520 
8,647,667 
9,023,401 
8,529,948 
8,808,740 
8,309,060
AstraZeneca AB v. HEC Pharm Co., Ltd., 15-6025 (D.N.J.) Aug. 5, 2015 Hon. Mary L. Cooper Nexium® (esomeprazole magnesium delayed-release tablets)
6,369,085 
7,411,070 
8,466,175
Purdue Pharma L.P. v. Collegium Pharm., Inc., 15-13099 (D. Mass.) Aug. 6, 2015 Hon. F. Dennis Saylor, IV
OxyContin® (oxycodone extended-release tablets)
 
Xtampza ER™ (oxycodone extended-release capsules)
7,674,799 
7,674,800 
7,683,072 
8,652,497
Purdue Pharm. Products L.P. v. Lannett Holdings, Inc., 15-6036 (D.N.J.) Aug. 6, 2015 Hon. Susan D. Wigenton Dilaudid® (hydromorphone hydrochloride oral solution) 6,589,960
AstraZeneca Pharms. LP v. Agila Specialties, Inc., 15-6039 (D.N.J.) Aug. 6, 2015 Hon. Renee Marie Bumb Faslodex® (fulvestrant injection)
6,774,122 
7,456,160 
8,329,680 
8,466,139
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 15-6075 (D.N.J.) Aug. 6, 2015 Hon. Peter G. Sheridan Noxafil® (posaconazole delayed-release tablets) 5,661,151
Collegium Pharm., Inc. v. Purdue Pharma L.P., 15-6179 (S.D.N.Y.) Aug. 6, 2015 Hon. Katherine B. Forrest
OxyContin® (oxycodone extended-release tablets) 
 
Xtampza ER™ (oxycodone extended-release capsules)
7,674,799 
7,674,800 
7,683,072 
8,652,497
Eli Lilly and Co. v. Emcure Pharms Ltd., 15-1244 (S.D. Ind.) Aug. 7, 2015 Hon. Jane Magnus-Stinson Alimta® (pemetrexed for injection) 7,772,209
AstraZeneca AB v. Lupin Ltd., 15-6092 (D.N.J.) Aug. 7, 2015 Hon. Mary L. Cooper Nexium 24HR® (esomeprazole magnesium delayed-release capsules)
6,369,085 
7,411,070
Coalition for Affordable Drugs VII LLC v. Pozen Inc., IPR2015-01680 (PTAB) Aug. 7, 2015 N/A Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 8,852,636
Hospira, Inc. v. Amneal Pharms. LLC, 15-0697 (D. Del.) Aug. 11, 2015 Hon. Richard G. Andrews Precedex® (dexmedetomidine hydrochloride injection)
8,242,158 
8,338,470 
8,455,527 
8,648,106
Par Pharm., Inc. v. TWi Pharms., Inc., 15-0698 (D. Del.) Aug. 11, 2015 Hon. Sue L. Robinson Megace® ES (megestrol acetate oral suspension)
9,101,540 
9,101,549
Boehringer Ingelheim Pharms. Inc. v. Intas Pharms., Ltd., 15-0664 (M.D.N.C.) Aug. 11, 2015 Hon. Catherine C. Eagles Jentadueto® (linagliptin / metformin hydrochloride tablets)
8,673,927 
8,846,695
Horizon Pharma Ireland Ltd v. Actavis Labs. UT, Inc., 15-6131 (D.N.J.) Aug. 11, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,101,591
Horizon Pharma Ireland Ltd v. Amneal Pharms. LLC, 15-6132 (D.N.J.) Aug. 11, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,101,591
Horizon Pharma Ireland Ltd v. IGI Labs., Inc., 15-6134 (D.N.J.) Aug. 11, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,101,591
Horizon Pharma Ireland Ltd v. Taro Pharms. USA, Inc., 15-6135 (D.N.J.) Aug. 11, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,101,591
Coalition for Affordable Drugs VII LLC v. Horizon Pharma USA, Inc., IPR2015-01718 (PTAB) Aug. 12, 2015 N/A Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 8,945,621
Millennium Pharms., Inc. v. Pharmascience Inc., 15-0702 (D. Del.) Aug. 13, 2015 Hon. Gregory M. Sleet Velcade® (bortezomib for injection)
6,713,446 
6,958,319
Coalition for Affordable Drugs IX LLC v. Bristol-Myers Squibb Co., IPR2015-01723 (PTAB) Aug. 13, 2015 N/A Eliquis® (apixaban tablets) 6,967,208
Noven Therapeutics, LLC v. Actavis Labs. FL, Inc., 15-6225 (D.N.J.) Aug. 14, 2015 Hon. Claire C. Cecchi Brisdelle® (paroxetine mesylate capsules) 8,946,251
Vivus, Inc. v. Actavis Labs. FL, Inc., 15-6256 (D.N.J.) Aug. 17, 2015 Hon. Stanley R. Chesler Qsymia® (phentermine / topiramate extended-release capsules)
9,011,905 
9,011,906
Par Pharm., Inc. v. TWi Pharms., Inc., 15-0710 (D. Del.) Aug. 18, 2015 Hon. Sue L. Robinson Megace® ES (megestrol acetate oral suspension) 9,107,827
Dr. Reddy’s Labs., Inc. v. Fresenius Kabi USA, LLC, 15-0714 (D. Del.) Aug. 18, 2015 Hon. Richard G. Andrews Diprivan® (propofol injectable emulsion) 8,476,010
Lupin Ltd. v. Pozen, Inc., IPR2015-01773 (PTAB) Aug. 19, 2015 N/A Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 8,858,996
Lupin Ltd. v. Pozen, Inc., IPR2015-01774 (PTAB) Aug. 19, 2015 N/A Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 8,852,636
Lupin Ltd. v. Pozen, Inc., IPR2015-01775 (PTAB) Aug. 19, 2015 N/A Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 8,865,190
Coalition for Affordable Drugs X LLC v. Anacor Pharms., Inc., IPR2015-01776 (PTAB) Aug. 20, 2015 N/A Kerydin® (Tavaborole topical solution) 7,582,621
Dr. Reddy’s Labs., Ltd. v. Galderma Labs., Inc., IPR2015-01777 (PTAB) Aug. 20, 2015 N/A Oracea® (doxycycline capsules) 8,603,506
Dr. Reddy’s Labs., Ltd. v. Galderma Labs., Inc., IPR2015-01778 (PTAB) Aug. 20, 2015 N/A Oracea® (doxycycline capsules) 8,603,506
Coalition for Affordable Drugs X LLC v. Anacor Pharms., Inc., IPR2015-01780 (PTAB) Aug. 20, 2015 N/A Kerydin® (Tavaborole topical solution) 7,767,657
Dr. Reddy’s Labs., Ltd. v. Galderma Labs., Inc., IPR2015-01782 (PTAB) Aug. 20, 2015 N/A Oracea® (doxycycline capsules) 8,603,506
Coalition for Affordable Drugs X LLC v. Anacor Pharms., Inc., IPR2015-01785 (PTAB) Aug. 20, 2015 N/A Kerydin® (Tavaborole topical solution) 7,767,657
Merck Sharp & Dohme Corp. v. Savior Lifetec Corp., 15-0415 (E.D.N.C.) Aug. 21, 2015 Hon. Terrence W. Boyle Invanz® (ertapenem for injection) 5,952,323
Otsuka Pharm. Co., Ltd. v. Standard Chem. & Pharm. Co., Ltd., 15-6353 (D.N.J.) Aug. 21, 2015 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets)
8,017,615 
8,580,796 
8,642,760 
8,759,350
Sumitomo Dainippon Pharma Co., Ltd. v. Teva Pharms. USA, Inc., 15-6401 (D.N.J.) Aug. 24, 2015 Hon. Stanley R. Chesler Latuda® (lurasidone hydrochloride tablets) 5,532,372
Allergan Inc, v. Teva Pharms. USA, Inc., 15-1455 (E.D. Tex.) Aug. 24, 2015 Hon. Rodney Gilstrap Restasis® (cyclosporine ophthalmic emulsion)
8,629,111 
8,633,162 
8,642,556 
8,648,048 
8,685,930
Coalition for Affordable Drugs XI LLC v. Insys Pharma, Inc., IPR2015-01797 (PTAB) Aug. 24, 2015 N/A Subsys® (fentanyl sublingual spray) 8,835,459
Coalition for Affordable Drugs XI LLC v. Insys Pharma, Inc., IPR2015-01799 (PTAB) Aug. 24, 2015 N/A Subsys® (fentanyl sublingual spray) 8,835,460
Coalition for Affordable Drugs XI LLC v. Insys Pharma, Inc., IPR2015-01800 (PTAB) Aug. 24, 2015 N/A Subsys® (fentanyl sublingual spray) 8,486,972
Cephalon, Inc. v. Panacea Biotec, Ltd., 15-0735 (D. Del.) Aug. 25, 2015 Hon. Sue L. Robinson Treanda® (bendamustine hydrochloride for infusion)
8,445,524 
8,791,270 
8,669,279 
8,883,836 
8,895,756
Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms., Inc., 15-0145 (N.D.W.V.) Aug. 25, 2015 Hon. John Preston Bailey
Tradjenta® (linagliptin tablets) 
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
8,673,927 
8,846,695 
8,853,156
The Medicines Co. v. Sagent Pharms., Inc., 15-7507 (N.D. Ill.) Aug. 26, 2015 Hon. Harry D. Leinenweber Angiomax® (bivalirudin for injection)
7,582,727 
7,598,343
Amneal Pharms. LLC v. Jazz Pharms., Inc., IPR2015-01810 (PTAB) Aug. 26, 2015 N/A Xyrem® (sodium oxybate oral solution) 7,895,059
Amneal Pharms. LLC v. Jazz Pharms., Inc., IPR2015-01817 (PTAB) Aug. 26, 2015 N/A Xyrem® (sodium oxybate oral solution) 8,457,988
Forest Labs., LLC v. Amneal Pharms. LLC, 15-0756 (D. Del.) Aug. 27, 2015 Hon. Leonard P. Stark Namzaric® (memantine hydrochloride / donepezil hydrochloride extended-release capsules)
8,039,009 
8,058,291 
8,168,209 
8,173,708 
8,283,379 
8,293,794 
8,329,752 
8,338,485 
8,338,486 
8,362,085 
8,580,858 
8,598,233
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01813 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 8,589,182
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01814 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 8,457,988
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01815 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 7,765,106
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01816 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 7,895,059
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01818 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 7,668,730
Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01820 (PTAB) Aug. 27, 2015 N/A Xyrem® (sodium oxybate oral solution) 7,765,107
Warner Chilcott (US), LLC v. Teva Pharms. USA, Inc., 15-1471 (E.D. Tex.) Aug. 28, 2015 Hon. Rodney Gilstrap Delzicol® (mesalamine delayed-release capsules) 6,649,180
Galderma Labs., L.P. v. Taro Pharms. U.S.A., Inc., 15-2814 (N.D. Tex.) Aug. 28, 2015 Hon. Ed Kinkeade Epiduo® (adapalene /benzoyl peroxide gel)
8,071,644 
8,080,537 
8,129,362  
8,445,543 
8,809,305
Coalition for Affordable Drugs VIII LLC v. The Trustees of The University of Pennsylvania, IPR2015-01835 (PTAB) Aug. 28, 2015 N/A Juxtapid® (lomitapide mesylate capsules) 8,618,135
Coalition for Affordable Drugs VIII LLC v. The Trustees of The University of Pennsylvania, IPR2015-01836 (PTAB) Aug. 28, 2015 N/A Juxtapid® (lomitapide mesylate capsules) 7,932,268
Janssen Pharmaceutica, N.V. v. Mylan Pharms., Inc., 15-0760 (D. Del.) Aug. 31, 2015 Hon. Sue L. Robinson Complera® (emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate tablets)
8,841,310 
7,125,879 
8,101,629
Warner Chilcott (US), LLC v. Teva Pharms. USA, Inc., 15-0761 (D. Del.) Aug. 31, 2015 Hon. Gregory M. Sleet Delzicol® (mesalamine delayed-release capsules) 6,649,180
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 15-6541 (D.N.J.) Aug. 31, 2015 Hon. William H. Walls Dificid® (fidaxomicin tablets)
7,906,489 
8,586,551 
7,378,508 
7,863,249 
8,859,510
Gilead Sciences, Inc. v. Mylan Inc., 15-0149 (N.D.W.V.) Aug. 31, 2015 Hon. Irene M. Keeley Complera® (emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate tablets)
6,642,245 
6,703,396 
8,592,397 
8,716,264
Jazz Pharms., Inc. v. Lupin Ltd., 15-6548 (D.N.J.) Sept. 1, 2015 Hon. Esther Salas Xyrem® (sodium oxybate oral solution)
6,472,431 
6,780,889 
7,262,219 
7,851,506 
8,263,650 
8,324,275 
8,461,203 
7,668,730 
7,765,106 
7,765,107 
7,895,059 
8,457,988
8,589,182 
8,731,963 
8,772,306 
8,859,619 
8,952,062 
9,050,302
Osi Pharms., LLC v. Apotex Inc., 15-0772 (D. Del.) Sept. 2, 2015 Hon. Sue L. Robinson Tarceva® (erlotinib hydrochloride tablets) 6,900,221
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 15-61858 (S.D. Fla.) Sept. 2, 2015 Hon. Kathleen M. Williams Dificid® (fidaxomicin tablets)
7,906,489 
8,586,551 
7,378,508 
7,863,249 
8,859,510
Omeros Corp. v. Par Sterile Products, LLC, 15-6561 (D.N.J.) Sept. 2, 2015 Hon. Jose L. Linares Omidria® (phenylephrine / ketorolac injection)
8,173,707 
8,586,633 
9,066,856
Jazz Pharms., Inc. v. Amneal Pharms. LLC, 15-6562 (D.N.J.) Sept. 2, 2015 Hon. Esther Salas Xyrem® (sodium oxybate oral solution) 9,050,302
AstraZeneca AB v. Alkem Labs. Ltd., 15-6609 (D.N.J.) Sept. 2, 2015 Hon. Mary L. Cooper Nexium® (esomeprazole magnesium delayed-release capsules)
6,369,085 
7,411,070 
8,466, 175
AstraZeneca AB v. Actavis Elizabeth LLC, 15-6610 (D.N.J.) Sept. 2, 2015 Hon. Mary L. Cooper Nexium 24HR® (esomeprazole magnesium delayed-release capsules)
6,369,085 
7,411,070
Janssen Pharmaceutica, N.V. v. Mylan Pharms., Inc., 15-0152 (N.D.W.V.) Sept. 2, 2015 Hon. Irene M. Keeley Complera® (emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate tablets)
8,841,310 
7,125,879 
8,101,629
Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-01850 (PTAB) Sept. 2, 2015 N/A Ampyra® (dalfampridine extended-release tablets) 8,440,703
Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-01853 (PTAB) Sept. 2, 2015 N/A Ampyra® (dalfampridine extended-release tablets) 8,007,826
Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-01857 (PTAB) Sept. 2, 2015 N/A Ampyra® (dalfampridine extended-release tablets) 8,663,685
Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-01858 (PTAB) Sept. 2, 2015 N/A Ampyra® (dalfampridine extended-release tablets) 8,354,437
Omeros Corp. v. Par Sterile Products, LLC, 15-0773 (D. Del.) Sept. 3, 2015 Hon. Richard G. Andrews Omidria® (phenylephrine / ketorolac injection)
8,173,707 
8,586,633 
9,066,856
Spectrum Pharms., Inc. v. Amneal Pharms. LLC, 15-1697 (D. Nev.) Sept. 3, 2015 Hon. James C. Mahan Fusilev® (levoleucovorin calcium for injection) 6,500,829
Purdue Pharma L.P. v. Alvogen Pine Brook, Inc., 15-0784 (D. Del.) Sept. 4, 2015 Hon. Gregory M. Sleet Hysingla® ER (hydrocodone bitartrate extended-release tablets)
9,056,052 
9,060,940
Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01871 (PTAB) Sept. 4, 2015 N/A Prolensa® (bromfenac ophthalmic solution) 8,129,431
Allergan, Inc. v. Innopharma, Inc., 15-1504 (E.D. Tex.) Sept. 8, 2015 Hon. Rodney Gilstrap Restasis® (cyclosporine ophthalmic emulsion)
8,629,111 
8,633,162 
8,642,556 
8,648,048 
8,685,930
Meda Pharms. Inc. v. Teva Pharms. USA, Inc., 15-0785 (D. Del.) Sept. 8, 2015 Hon. Leonard P. Stark Dymista® (azelastine hydrochloride / fluticasone propionate nasal spray)
8,163,723 
8,168,620
Millennium Pharms., Inc. v. Hospira, Inc., 15-0804 (D. Del.) Sept. 10, 2015 Hon. Richard G. Andrews Velcade® (bortezomib for injection)
6,713,446 
6,958,319
Janssen Pharmaceutica N.V. v. Apotex Inc., 15-7121 (S.D.N.Y.) Sept. 10, 2015 Hon. William H. Pauley, III Sporanox® (itraconazole oral solution) 6,407,079
Kowa Co., Ltd. v. Zydus Pharms. (USA) Inc., 15-7136 (S.D.N.Y.) Sept. 10, 2015 Hon. Paul A. Crotty Livalo® (pitavastatin calcium tablets) 6,465,477
Merck Sharp & Dohme B.V. v. Teva Pharms. USA, Inc., 15-0806 (D. Del.) Sept. 11, 2015 Hon. Gregory M. Sleet NuvaRing® (ethinyl estradiol / etonogestrel vaginal ring) 5,989,581
Kowa Co., Ltd. v. Zydus Pharms. (USA) Inc., 15-6792 (D.N.J.) Sept. 11, 2015 Hon. Freda L. Wolfson Livalo® (pitavastatin calcium tablets) 6,465,477
Depomed, Inc. v. Actavis Elizabeth LLC, 15-6797 (D.N.J.) Sept. 11, 2015 Hon. Claire C. Cecchi Nucynta® ER (tapentadol hydrochloride extended-release tablets) 8,536,130
Allergan Inc, v. Teva Pharms. USA, Inc., 15-0815 (D. Del.) Sept. 14, 2015 Hon. Sue L. Robinson Restasis® (cyclosporine ophthalmic emulsion)
8,629,111 
8,633,162 
8,642,556 
8,648,048 
8,685,930
Amneal Pharms. LLC v. Jazz Pharms., Inc., IPR2015-01903 (PTAB) Sept. 14, 2015 N/A Xyrem® (sodium oxybate oral solution) 8,731,963
Otsuka Pharm. Co., Ltd. v. Hetero USA Inc., 15-0822 (D. Del.) Sept. 15, 2015 Hon. Richard G. Andrews Samsca® (tolvaptan tablets) 5,753,677
Acorda Therapeutics, Inc. v. Par Pharm., Inc., 15-0824 (D. Del.) Sept. 15, 2015 Hon. Leonard P. Stark Ampyra® (dalfampridine extended-release tablets)
8,007,826 
8,354,437 
8,440,703 
8,663,685
Gilead Sciences, Inc. v. Lupin Pharms., Inc., 15-2793 (D. Md.) Sept. 16, 2015 Hon. J. Frederick Motz Tamiflu® (oseltamivir phosphate capsules) 5,763,483
Purdue Pharma L.P. v. Amneal Pharms. LLC, 15-0831 (D. Del.) Sept. 17, 2015 Hon. Sue L. Robinson OxyContin® (oxycodone extended-release tablets)
9,060,976 
9,034,376
Impax Labs., Inc. v. Actavis Labs. FL, Inc., 15-6934 (D.N.J.) Sept. 17, 2015 Hon. Katharine S. Hayden Rytary® (levodopa / carbidopa capsules)
7,094,427 
8,377,474 
8,454,998 
8,557,283 
9,089,607 
9,089,608
Horizon Pharma Ireland Ltd. v. Lupin Ltd., 15-6935 (D.N.J.) Sept. 17, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,132,110
Horizon Pharma Ireland Ltd. v. Actavis Labs. UT, Inc., 15-6989 (D.N.J.) Sept. 17, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,132,110
Horizon Pharma Ireland Ltd. v. Amneal Pharms. LLC, 15-6990 (D.N.J.) Sept. 17, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,132,110
Horizon Pharma Ireland Ltd. v. IGI Labs., Inc., 15-6991 (D.N.J.) Sept. 17, 2015 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution) 9,132,110
Bayer Pharma AG v. alembic Pharms. Ltd., 15-0832 (D. Del.) Sept. 18, 2015 Hon. Gregory M. Sleet Staxyn® (vardenafil hydrochloride tablets) 8,613,950
Vivus, Inc. v. Teva Pharms. USA, Inc., 15-6957 (D.N.J.) Sept. 18, 2015 Hon. Stanley R. Chesler Qsymia® (phentermine / topiramate extended-release capsules)
9,011,905 
9,011,906
AstraZeneca Pharms. LP v. Mylan Pharms. Inc., 15-7009 (D.N.J.) Sept. 21, 2015 Hon. Renee Marie Bumb Faslodex® (fulvestrant injection)
6,774,122 
7,456,160 
8,329,680 
8,466,139
Astellas Pharma Inc. v. Apotex Inc., 15-0857 (D. Del.) Sept. 22, 2015 Hon. Sue L. Robinson Mycamine® (micafungin sodium for injection)
6,107,458 
6,774,104
Taro Pharms. U.S.A., Inc. v. Perrigo UK Finco Ltd., 15-0859 (D. Del.) Sept. 22, 2015 Hon. Richard G. Andrews Topicort® (desoximetasone topical spray)
8,277,780 
8,715,624
Helsinn Healthcare S.A. v. Fresenius Kabi USA, LLC, 15-7015 (D.N.J.) Sept. 23, 2015 Hon. Mary L. Cooper Aloxi® (palonosetron hydrochloride for injection)
7,947,724 
7,947,725 
7,960,424 
8,598,219 
8,729,094
Helsinn Healthcare S.A. v. Fresenius Kabi USA, LLC, 15-0865 (D. Del.) Sept. 24, 2015 Hon. Gregory M. Sleet Aloxi® (palonosetron hydrochloride for injection)
7,947,724 
7,947,725 
7,960,424
8,598,219 
8,729,094
Amneal Pharms. LLC v. Yeda Research and Development Co., Ltd., IPR2015-01976 (PTAB) Sept. 25, 2015 N/A Copaxone® (glatiramer acetate for injection) 8,232,250
Amneal Pharms. LLC v. Yeda Research and Development Co., Ltd., IPR2015-01980 (PTAB) Sept. 25, 2015 N/A Copaxone® (glatiramer acetate for injection) 8,399,413
Amneal Pharms. LLC v. Yeda Research and Development Co., Ltd., IPR2015-01981 (PTAB) Sept. 25, 2015 N/A Copaxone® (glatiramer acetate for injection) 8,969,302
Coalition For Affordable Drugs V LLC v. Biogen MA, Inc., IPR2015-01993 (PTAB) Sept. 28, 2015 N/A Tecfidera® (dimethyl fumarate delayed-release capsule) 8,399,514
Mylan Pharms. Inc. v. 3M Co., IPR2015-02002 (PTAB) Sept. 29, 2015 N/A
Ventolin HFA® (albuterol sulfate inhalator) 
 
Flovent HFA® (fluticasone propionate inhalator) 
 
Advair HFA® (fluticasone propionate / salmeterol xinafoate inhalator)
6,743,413
Salix Pharms., Inc. v. Apotex, Inc., 15-0880 (D. Del.) Sept. 30, 2015 Hon. Gregory M. Sleet Giazo® (balsalazide disodium tablets)
6,197,341 
8,497,256

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