ANDA Litigation Settlements

Fall 2016

Case Name	Drug	Patent No(s).	Publicly Available Terms
AstraZeneca Pharms. LP v. Sagent Pharms. Inc., 14-3547 (D.N.J.)	Faslodex® (fulvestrant for injection)	6,774,122 7,456,160 8,329,680 8,466,139	The patents-in-suit remain valid until they expire in January 2021. Sandoz may launch its generic ANDA product on Mar. 25, 2019, or earlier under undisclosed circumstances.
Allos Therapeutics Inc. v. Teva Pharms. USA Inc., 14-0778 (D. Del.)	Folotyn® (pralatrexate)	6,028,071 7,622,470 8,299,078	Fresenius Kabi USA LLC would be allowed to market its ANDA product in the U.S. starting Nov. 15, 2022, or earlier under certain circumstances.
Celgene Corp. v. Teva Pharms. USA Inc., 15-1143 (D. Del.)	Istodax® (romidepsin)	7,608,280 7,611,724	N/A
Teva Pharmas. USA Inc. v. Forest Labs. Inc., 13-2002 (D. Del.)	Namenda XR® (memantine hydrochloride extended-release capsules)	6,194,000	N/A
Cosmo Technologies Ltd. v. Par Pharms. Inc., 15-0116 (D. Del.)	Uceris® (budesonide)	7,410,651 7,431,943 8,293,273 8,784,888 8,895,064 RE43,799 9,192,581 9,320,716	Par agrees that the patents-in-suit are valid and enforceable, and it will not market its ANDA product unless authorized by the settlement.
Braintree Labs., Inc. v. Novel Labs., Inc., 11-1341 (D.N.J.)	Suprep® Bowel Prep Kit (magnesium sulfate / potassium sulfate / sodium sulfate)	6,946,149	N/A
In re: Bendamustine Consolidated Cases, 13-2046 (D. Del.)	Treanda® (bendamustine hydrochloride injection)	8,791,270 8,895,756	Licensing and settelement agreements were reached between Cephalon and Sagent, Cephalon and Intas Pharmaceuticals, and Cephalon and Hetero Labs.
Gilead Sciences Inc. v. Hetero Drugs Ltd., 16-4938 (D.N.J.)	Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets)	6,642,245 6,703,396 8,592,397 8,716,264	N/A
Forest Labs. LLC v. Amneal Pharms. LLC, 15-0756 (D. Del.)	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	Amneal admits its proposed ANDA productwould infringe the patents-in-suit. No determinations as to the validity of the patents. If FDA approves Amneal’s ANDA, Amneal may launch its generic product on Jan. 1, 2025, but under some undisclosed circumstances could be delayed until Jan. 1, 2026.
AbbVie Inc. v. Amneal Pharms. LLC, 16-0398 (D. Del.)	Norvir® (ritonavir tablets)	7,148,359 7,364,752	N/A