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ANDA Litigation Settlements
Winter 2012
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
Case Name |
Drug |
Patent No(s). |
Publicly Available Terms |
Shionogi Pharma. Inc. v. Mylan Pharma. Inc., 10-1077 (D. Del.) |
Orapred ODT®(prednisolone sodium phosphate orally disintegrating tablets) |
6,740,341 |
Mylan will sell its generic product in three different dosage strengths beginning April 1, 2014. |
In re: Nebivolol (’040) Patent Litigation, 12-5026 (N.D. Ill.) |
Nebivolol®(bystolic tablets) |
6,545,040 |
Forest will give Hetero a license to release a generic version of nebivolol when the FDA approves Hetero’s ANDA or three months prior to the expiration of Forest’s patent, whichever comes first. |
Janssen Pharma. Inc. v. Mylan Inc.,10-6018 (D.N.J.) |
Ortho Tri-cyclen Lo®(norgestimate / ethinyl estradiol tablets) |
6,214,815 |
Mylan shall sell a generic version of Ortho Tri-Cyclen Lo starting Dec. 31, 2015. |
Cumberland Pharma. Inc. v. Perrigo Co., 12-6327 (N.D. Ill.) Cumberland Pharma Inc. v. Paddock Labs. LLC, 12-0619 (D. Del.) |
Acetadote®(acetylcysteine injection) |
8,148,356 |
Perrigo, which acquired Paddock, agreed not to challenge the ’356 patent; and Perrigo will launch its generic product upon the ’356 patent’s expiration in 2026. |
Cadence Pharma. Inc. v. Paddock Labs., 11-0733 (D. Del.) |
Ofirmev®(acetaminophen injection) |
6,028,222 6,992,218 |
Perrigo has exclusive right of first refusal to negotiate an agreement with Cadence to market an authorized generic should Cadence elect to launch; Cadence grants Perrigo a nonexclusive right to market the generic product beginning in December 2020; and Perrigo will purchase any authorized generic only from Cadence, and it will pay royalties on top of manufacturing costs and an administrative fee. |
Bone Care Int’l LLC v. Pentech Pharma., Inc., 08-1083 (N.D. Ill.) |
Hectorol®(doxercalciferol capsules and injection) |
5,602,116 |
N/A |
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