ANDA Litigation Settlements

Spring 2013

GENERICally Speaking
Case Name Drug Patent No(s). Publicly Available Terms
In re: Nebivolol patent litigation, 12-5026 (N.D. Ill.) Bystolic® (nebivolol tablets) 6,545,040

Forest Labs., Inc. to give Glenmark Pharma. Ltd. a license to release generic nebivolol either when the FDA approves Glenmark’s ANDA or three months prior to patent expiration, whichever is first.

Mallinckrodt LLC v. Apotex, Inc., 12-1087 (D.Del.) Pennsaid® (diclofenac sodium topical solution) 8,217,078

Apotex may release its generic product, a 1.5% by weight solution, 45 days after Mallinckrodt makes its first commercial shipment of Pennsaid 2%, a new version of the drug, or April 1, 2014, whichever comes first.

Apotex may also release its 1.5% version earlier under certain unspecified circumstances.

Purdue Pharma LP v. Ranbaxy Inc, 10-3734 (S.D.N.Y.) OcyContin® (oxycodone hydrochloride extended-release tablets) 7,674,799; 7,674,800; 7,683,072

Ranbaxy admits to infringing the asserted patents.

Ranbaxy waived possible antitrust or other claims against Purdue.


AstraZeneca Pharma. LP v. Torrent Pharma. Ltd., 10-4205 (D.N.J.) Seroquel XR® (quetiapine fumarate extended-release tablets) 5,948,437

Torrent admits that AstraZeneca’s patent is enforceable and valid.

Torrent agrees not to produce its generic version of the drug until November 2016.

Gilead Sciences Inc. v. Teva Pharma. USA Inc., 10-1796 (S.D.N.Y.) Viread® (tenofovir disoproxil fumarate tablets) 5,922,695; 5,935,946; 5,977,089; 6,043,230
Teva will be allowed to launch its generic product in December 2017.
Shionogi Pharma. Inc. v. Mylan Inc., 10-0135 (D. Del.) Fortamet® (metformin hydrochloride extended-release tablets) 6,099,859; 6,866,866

Mylan may launch a generic version of Fortamet on Aug. 1 or earlier under certain conditions.

AstraZeneca UK Ltd. v. Watson Pharma. Inc., 10-0915 (D. Del.) Crestor® (rosuvastatin calcium) RE37,314
Actavis is allowed to launch its generic product on May 2, 2016—67 days before the expiration of AstraZeneca’s pediatric exclusivity period.

Actavis has conceded the validity and enforceability of the ’314 patent, and has agreed not to further appeal a December decision by the Federal Circuit upholding the validity of the patent.

Actavis will pay a fee equal to 39% of the net sales of its rosuvastatin drugs to AstraZeneca for that 67-day early launch period.

Allergan Inc. v. Athena Cosmetics Inc., 07-1316 (C.D. Ca.) Latisse® (bimatoprost ophthalmic solution) 6,262,105; 7,351,404; 7,388,029 N/A

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