Print

ANDA Litigation Settlements

Case Name Drug Patent No(s). Publicly Available Terms
Mallinckrodt IP Unlimited Co. v. B. Braun Medical Inc., 17-0365, 17-0660, 18-1090 (D. Del.) Ofirmev® (acetaminophen for injection) 9399012
6992218
The parties entered a confidential settlement under which they agreed to enter into licensing agreements relating to the patents-in-suit.
The parties further agreed to cover their own costs and attorneys’ fees.
Gilead Sciences Inc. v. Aurobindo Pharma Ltd., 18-0765 (D. Del.) Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) 6642245
6703396
N/A
Eisai Co., Ltd. v. Bionpharma Inc., 18-0618 (D. Del.) Banzel® (rufinamide tablets) 6740669
7750028
N/A
Adverio Pharma GmbH v. Teva Pharmas. USA, Inc., 18-0112 (D. Del.) Adempas® (riociguat tablets) 7,173,037 N/A
Bayer Healthcare LLC v. Teva Pharms. USA, Inc., 16-1220 (D. Del.) Nexavar® (sorafenib tosylate tablets) 8,877,933 N/A
Bayer Healthcare LLC v. Apotex Inc., 18-1539 (D. Del.) Nexavar® (sorafenib tosylate tablets) 8877933
9737488
N/A
Shionogi Inc. v. Qingdao Baheal Pharm. Co. Ltd., 17-1347 (D. Del.) Fortamet® (metformin HCl extended-release tablets) 6790459
6866866
N/A
Teijin Ltd. v. Torrent Pharms. Ltd., 18-0987 (D. Del.) Uloric® (febuxostat tablets) 7361676
9107912
8372872
All claims, counterclaims and affirmative defenses of the parties are dismissed without prejudice.
All parties shall each bear their own costs and attorney fees.
The Court shall retain jurisdiction over the parties and this action to enforce the terms of the Settlement and License Agreement.
Teijin Ltd. v. MSN Labs. Private Ltd., 18-0881 (D. Del.) Uloric® (febuxostat tablets) 7361676
9107912
8372872
All claims, counterclaims and affirmative defenses of the parties are dismissed without prejudice.
All parties shall each bear their own costs and attorney fees.
The Court shall retain jurisdiction over the parties and this action to enforce the terms of the Settlement and License Agreement.
Baxter Healthcare Corp. v. Hospira, Inc., 18-0303 (D. Del.) Precedex® (dexmedetomidine HCl for injection) 6716867
8242158
8338470
8455527
All claims brought by Baxter and all counterclaims brought by Hospira are dismissed with prejudice.
Each party shall bear its own attorneys’ fees, expenses, and other costs.
Allergan, Inc. v. Aurobindo Pharma Ltd., 17-1290 (D. Del.) Lastacaft® (alcaftadine ophthalmic solution) 8,664,215 Aurobindo’s ANDA technically infringes the ’215 patent.
Aurobindo is enjoined from manufacturing, using, offering to sell, or selling its ANDA product during the life of the ’215 patent.
Parties waive any right to appeal.
Aurobindo’s counterclaims are dismissed witout prejudice.
Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharms. Ltd., 18-2065 (D.N.J.) Latuda® (lurasidone HCl tablets) 9815827
9907794
Amneal, Emcure, Zydus, Torrent, and Aurobindo admit that the ’827 patent is valid and infringed.
InvaGen, Dr. Reddy’s, and Accord admit that the ’794 and ’827 patents are valid and infringed.
Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC, 18-0196 (D. Del.) Noxafil® (posaconazole for injection) 9023790
9358297
N/A
AstraZeneca LP v. Amneal Pharms. LLC, 15-1056 (D. Del.) Brilinta® (ticagrelor tablets) 6251910
6525060
7250419
7265124
8425934
Amneal is enjoined from infringing the US Patents Nos. 6,251,910; RE46,276 (6,525,060); 7,250,419; and 7,265,124.
All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs.
AstraZeneca LP v. Hisun Pharm. (Hangzhou) Co., Ltd., 18-1232 (D. Del.) Brilinta® (ticagrelor tablets) RE46,276
7250419
7265124
Hisun is enjoined from infringing the patents-in-suit.
All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs.
Eli Lilly and Co. v. Apotex, Inc., 18-1037 (S.D. Ind.) Forteo® (teriparatide for injection) 7,517,334 N/A
Amgen Inc. v. Emcure Pharms. Ltd., 18-1393 (D. Del.) Sensipar® (cinacalcet tablets) 9,375,405 Defendants agree that ’405 patent is infringed, enforceable and valid.
All claims and demands for relief are satisfied
Astellas Pharma Inc. v. Actavis Labs. FL, Inc., 16-1120 (D. Del.) Xtandi® (enzalutamide capsules) 7709517
8183274
9126941
Plaintiffs’ claims against Hikma dismissed.
Hikma’s counter-claims against Plaintiffs dismissed.
Each party to bear its own costs.
Valeant Pharms. Luxembourg S.A.R.L. v. Zydus Pharms. (USA), Inc., 17-0449 (D.N.J.) Cardizem LA® (diltiazem hydrochloride extended-release tablets) 6,923,984 Zydus agrees that its ANDA product infringes any valid claim of the ’984 patent.
Zydus is enjoined from selling its ANDA product until the expiration of the ’984 patent.
Each party to bear its own costs.
Neos Therapeutics, Inc. v. Teva Pharms. USA, Inc., 17-1793 (D. Del.) Cotempla XR-ODT® (methylphenidate extended-release orally disintegrating tablets) 8840924
9072680
9089496
Teva is enjoined from commercially  manufacturing, using, offering to sell, or selling its ANDA product during the life of the patents-in-suit.
Each party to bear its own costs.
Novartis Pharms. Corp. v. Mylan Pharms. Inc., 17-0389 (D. Del.) Afinitor Disperz® (everolimus tablets) 5665772
8778962
8617598
N/A
Forest Labs., LLC v. Amneal Pharms. LLC, 17-11680 (D.N.J.) Fetzima® (levomilnacipran HCl extended-release capsules) 8481598
8865937
RE43,879
Amneal admits that submission of its ANDA ANDA before the expiration of the patents-in-suit was an act of infringement.
Amneal stipulates to the enforceability and validity of the patents-in-suit.
All other claims, defenses, and counterclaims are dismissed without prejudice.
H. Lundbeck A/S v. Amneal Pharms. LLC, 18-0175 (D. Del.) Trintellix® (vortioxetine hydrobromide tablets) 7144884
7,144,884
8,476,279
8,722,684
8,969,355
9,227,946
N/A
Gilead Sciences, Inc. v. Teva Pharms. USA, Inc., 18-4273 (D.N.J.) Sovaldi® (sofosbuvir tablets) 7,964,580
8,334,270
8,580,765
9,085,573
7,429,572
8,415,322
8,633,309
9,284,342
8,618,076
9,549,941
8,889,159
8,629,263
8,735,569
9,637,512
8,642,756
9,206,217
9,340,568

All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice.
Each party to bear its own costs and fees.
Parties waive any right to appeal.
Sumitomo Dainippon Pharma Co., Ltd. v. Alkem Labs. Ltd., 18-14787 (D.N.J.) Latuda® (lurasidone HCl tablets) 9815827
9907794
Alkem admits that the ’827 patent is enforceable and valid.
Alkem is enjoined from infringing the ’827 patent.
All claims and demands for relief prayed for by Plaintiffs against Alkem and Alkem against Plaintiffs in this action are deemed to be satisfied.

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.