ANDA Litigation Settlements

Abbott Labs. v. TevaPharma.USAInc., 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

Medicines Co. v. Kappos, 2010-1534 (Fed. Cir.)

Angiomax^®(bivalirudin for injection)

5,196,404

7,582,727

7,598,343

The settlement agreement includes a license by The Medicines Co. to APP Pharma. LLC to sell generic Angiomax in the U.S. starting May 1, 2019

Medicines will pay APP $30 million for a non-exclusive license to sell ten specified generic products to hospitals and suppliers until Jan. 22, 2022

APP to withdraw Federal Circuit appeal and acknowledge that the three patents-in-suit are valid and enforceable until their expiration in 2028

Mallinckrodt Inc. v. Watson Labs. Inc., 10-6424 (D.N.J.)

Exalgo^®(hydromorphone hydrochloride extended-release tablet)

5,914,131

Watson can introduce its generic product on Nov. 15, 2013 (almost 8 months before the patent-in-suit expires)

AstraZeneca AB v. Lupin Ltd, 09-5404 (D.N.J.); Lupin Ltd. v. Merck Sharp & Dohme Corp., 10-0683 (D.N.J.)

Nexium^®(esomeprazole magnesium extended-release capsule)

5,714,504

5,877,192

6,875,872

6,369,085

7,411,070

6,191,148

6,166,213

6,147,103

Lupin shall not manufacture or import its generic product in the U.S. before May 27, 2014, unless the parties allow otherwise.

Pfizer Inc. v. WatsonPharma.Inc., 10-0357 (D. Del.)

Rapamune^®(sirolimus tablet)

5,100,899

Pfizer settles suit only with Ranbaxy Labs. Ltd.

Janssen Pharma. Inc. v. Watson Labs. Inc., 08-5103 (D.N.J.)

Ortho Tri-Cyclen^®LO (norgestimate, ethinyl estradiol)

6,214,815

Watson authorized to sell generic product on Dec. 31, 2015 per supply agreement entered into by the parties.

Watson entitled to contest validity or enforceability of patent should it be sued in the future with additional infringement claims.

Pfizer Inc. v. Apotex Inc., 08-7231 (N.D. Ill.)

Lipitor^®(atorvastatin calcium)

5,969,156

5,686,104

6,126,971

N/A

Eli Lilly and Co. v. Zydus Pharma. USA, Inc., 11-2582 (D.N.J.)

Strattera^®(atomoxetine)

5,658,590

Any FDA approval of Zydus’ generic product cannot occur until after May 26, 2017