ANDA Litigation Settlements

Summer 2012

GENERICally Speaking

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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