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.