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ANDA Litigation Settlements
Summer 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 |
Abbott Labs. v. Teva Pharma. USA Inc., 10-0057, 10-0766, 11-0239, 11-0712 (D. Del.) |
Simcor®(simvastatin niacin extended-release) |
6,080,428 6,129,930 6,406,715 6,469,035 6,676,967 6,746,691 6,818,229 7,011,848 |
N/A |
Medicis Pharma. Corp. v. Perrigo Co., Inc., 11-4963 (S.D.N.Y.) |
Loprox®Shampoo (ciclopirox) |
7,981,909 |
N/A |
Sunovion Pharma. v. Dey Pharma., 06-0113 (D. Del.) |
Xopenex®(levalbuterol hydrochloride) |
5,362,755 5,547,994 5,760,090 5,844,002 6,083,993 6,451,289 |
Mylan may continue selling levalbuterol hydrochloride; Mylan receives a royalty-bearing license to sell a nonconcentrate version of the generic drug, following FDA approval. |
Endo Pharma. Inc. v. Watson Labs. Inc., 10-0138, 11-0575 (D. Del.) |
Lidoderm®(lidocaine transdermal) |
5,741,510 6,096,333 6,096,334 5,827,529 |
Watson may launch its generic product on Sept. 15, 2013, if approved by the FDA; Watson will have an exclusive license to market an authorized generic until the arrival of a third party or until 7.5 months after Watson’s launch; Endo will take 25% of the gross profit from Watson’s sales during the company’s period of exclusivity; Watson will get approximately $96 million worth of branded Lidoderm to sell during the first 8 months of 2013; If Watson does not get FDA approval by January 2014, it will receive $80 million worth of Lidoderm in 2014 over a period of 12 months; If Watson does not get FDA approval by January 2015, it will receive $64 million worth of Lidoderm in 2015 over a period of 9 months. |
Mylan Pharma. Inc. v. Sebelius, 12-0524 (D.D.C.) |
Provigil®(modafinil) |
RE37,516 |
“Pursuant to its agreement with Teva, Mylan is permitted to launch its generic product on Aug. 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva.” |
Pfizer Inc. v. Teva Parenteral Medicines Inc., 10-0037 (D. Del.) |
Zyvox®(linezolid for injection) |
5,688,792 |
Teva conceded ongoing validity of the ’792 patent; Teva agreed not to sell a product under its ANDA unless authorized by the parties’ licensing agreement. |
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