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ANDA Litigation Settlements

Case Name Drug Patent No(s). Publicly Available Terms
Forest Labs., LLC v. Sun Pharma Global FZE, 17-0865 (D. Del.) Linzess® (linaclotide capsules) 8,933,030 Sun Pharma will be able to sell its generic linaclotide product in February 2031, six months before the expiration of the patent-in-suit.
Boehringer Ingelheim Pharma GMBH & Co. KG v. Teva Pharms. USA, Inc., 14-7811 (D.N.J.) Pradaxa® (dabigatran etexilate mesylate capsules) 6,087,380 Mylan agreed that the patent-in-suit is valid and further agreed to delay launching its ANDA product.
Allergan, Inc. v. Innopharma, Inc., 15-1504 (E.D. Tex.) Restasis® (cyclosporine ophthalmic emulsion) 8,629,111
8,633,162
8,642,556
8,648,048
8,685,930
9,248,191
InnoPharma will be allowed to market its generic version of Restasis in February 2024 or possibly earlier. InnoPharma may also be allowed to launch an authorized generic version of the drug with Allergan as the supplier in August 2024.
Pernix Ireland Pain Ltd. v. Actavis Labs. FL, Inc., 16-0138 (D. Del.) Recro Gainesville LLC v. Actavis Labs. FL, Inc., 17-1535 (D. Del.) Recro Gainesville LLC v. Actavis Labs. FL, Inc., 17-1822 (Fed. Cir.) Zohydro® (hydrocodone bitartrate extended-release capsules) 9,265,760
9,326,982
9,333,201
9,339,499
9,421,200
9,433,619
6,228,398
6,902,742
9,132,096
9,713,611

Actavis will be able to launch its generic hydrocodone drug in March 2029.

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