ANDA Litigation Settlements

2011/2012

GENERICally Speaking
Case Name Drug Patent No(s). Publicly Available Terms

AstraZeneca Pharma. LP v. Accord Healthcare, 08-4804, 09-619 (D.N.J.)

Seroquel XR®(quetiapine fumarate)

5,948,437

Accord agreed not to sell generic Seroquel XR®until November 2016

‘437 patent does not expire until 2017

Pfizer Inc. v. Actavis Group HF, 10-675 (D. Del.)

Lipitor®(atorvastatin calcium)

5,969,156

5,686,104

6,126,971

N/A

AstraZeneca AB v. SunPharmaGlobalFZE, 10-1017 (D.N.J.)

Nexium®I.V. (esomeprazole sodium)

5,877,192

6,143,771

Sun Pharma agreed not to sell its generic drug until Jan. 2, 2014, without authorization

Abbott Labs. v. Impax Labs. Inc., 10-1322 (D.N.J.)

Trilipix®(fenofibric acid)

7,259,186

Impax may launch generic product on Jan. 1, 2014, or as early as July 15, 2013, under certain undisclosed conditions

‘186 patent does not expire until 2025

Bristol-Myers Squibb Co. v. TevaPharma.USAInc., 09-919 (D. Del.)

Reyatax®(atazanavir sulfate)

5,849,911

6,087,383

Teva may launch generic product in July 2017, or earlier, under certain undisclosed conditions

The ‘911 patent expires in June 2017 and the ‘383 patent expires in Dec. 2018

Pfizer Inc. v. AurobindoPharma. Ltd., 11-569 (D. Del.)

Lipitor®(atorvastatin calcium)

5,969,156

N/A

Bayer Schering Pharma AG v. TevaPharma.USAInc., 09-480 (D. Del.)

Levitra®(vardenafil HCl)

6,362,178

7,696,206

N/A

Vivelle Ventures LLC (Novartis) v. Mylan Tech. Inc., 11-1187 (S.D.N.Y.)

Vivelle Ventures LLC (Novartis) v. Mylan Tech. Inc., 11-50 (D. Vt.)

Vivelle Dot®(estradiol transdermal system)

5,656,286

6,024,976

Mylan to receive a patent license to begin selling its generic product in Dec. 2013, subject to approval by USDOJ and FTC

Valeant International (Barbados) SRL v. Par Pharma.Cos.Inc., 10-7310 (S.D.N.Y.)

Aplenzin®(buproprion HBr extended release tablets)

7,569,610

7,572,935

7,649,019

7,553,992

7,671,094

7,241,805

7,645,802

7,622,407

7,645,901

N/A

Teva Women’s Health Inc. V. Lupin Ltd., 10-0080 (D.N.J.)

LoSeasonique™ (ethinyl estradiol/levonorgestrel)

7,615,545

Watson may launch generic product on 12/14/2011

Pfizer Inc. v. SandozInc., 09-0742 (D. Del.)

Caduet®(amlodipine besylate/atorvastatin calcium)

6,455,574

5,969,156

6,126,971

5,686,104

N/A

Sanofi-Aventis v. SunPharma.Indus.Ltd., 08-6286 (S.D.N.Y.)

Plavix®(clopidogrel bisulfate)

6,429,210

N/A


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