ANDA Litigation Settlements

Winter 2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name


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)


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)


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)


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)


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)



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)




Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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