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Teva Pharmaceuticals IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF CONNECTICUT THE STATE OF CONNECTICUT; THE STATE OF ALABAMA; THE STATE OF ALASKA; Civil Action No. THE STATE OF ARIZONA; THE STATE OF COLORADO; THE STATE OF DELAWARE; THE STATE OF FLORIDA; THE STATE OF HAWAII; THE STATE OF IDAHO; May 10, 2019 THE STATE OF ILLINOIS; THE STATE OF INDIANA; THE STATE OF IOWA; COMPLAINT THE STATE OF KANSAS; THE COMMONWEALTH OF KENTUCKY; THE STATE OF LOUISIANA; THE STATE OF MAINE; THE STATE OF MARYLAND; Non-Public Version: Filed Under Seal THE COMMONWEALTH OF MASSACHUSETTS; THE STATE OF MICHIGAN; THE STATE OF MINNESOTA; THE STATE OF MISSISSIPPI; THE STATE OF MISSOURI; THE STATE OF MONTANA; THE STATE OF NEBRASKA; THE STATE OF NEVADA; THE STATE OF NEW JERSEY; THE STATE OF NEW MEXICO; THE STATE OF NEW YORK; THE STATE OF NORTH CAROLINA; THE STATE OF NORTH DAKOTA; THE STATE OF OHIO; THE STATE OF OKLAHOMA; THE STATE OF OREGON; THE COMMONWEALTH OF PENNSYLVANIA; THE COMMONWEALTH OF PUERTO RICO; THE STATE OF RHODE ISLAND; THE STATE OF SOUTH CAROLINA; THE STATE OF TENNESSEE; THE STATE OF UTAH; THE STATE OF VERMONT; THE COMMONWEALTH OF VIRGINIA; THE STATE OF WASHINGTON; THE STATE OF WEST VIRGINIA; THE STATE OF WISCONSIN; v. TEVA PHARMACEUTICALS USA, INC.; ACTAVIS HOLDCO US, INC.; ACTAVIS PHARMA, INC.; AMNEAL PHARMACEUTICALS, INC.; APOTEX CORP.; ARA APRAHAMIAN; AUROBINDO PHARMA U.S.A., INC.; DAVID BERTHOLD; BRECKENRIDGE PHARMACEUTICAL, INC.; JAMES (JIM) BROWN; MAUREEN CAVANAUGH; TRACY SULLIVAN DIVALERIO; DR. REDDY'S LABORATORIES, INC.; MARC FALKIN; GLENMARK PHARMACEUTICALS, INC., USA; JAMES (JIM) GRAUSO; KEVIN GREEN; GREENSTONE LLC; ARMANDO KELLUM; LANNETT COMPANY, INC.; LUPIN PHARMACEUTICALS, INC.; MYLAN PHARMACEUTICALS INC.; JILL NAILOR; JAMES (JIM) NESTA; PAR PHARMACEUTICAL COMPANIES, INC.; NISHA PATEL; PFIZER, INC.; KONSTANTIN OSTAFICIUK; DAVID REKENTHALER; RICHARD (RICK) ROGERSON; SANDOZ, INC.; TARO PHARMACEUTICALS USA, INC. UPSHER-SMITH LABORATORIES, LLC; WOCKHARDT USA LLC; ZYDUS PHARMACEUTICALS (USA), INC. TABLE OF CONTENTS PAGE I. SUMMARY OF THE CASE ........................................................................................... 2 II. JURISDICTION AND VENUE ...................................................................................... 9 III. THE PARTIES.................................................................................................................. 10 IV. FACTS SUPPORTING THE LEGAL CLAIMS ............................................................. 18 A. Factual Support For The Allegations ................................................................... 18 B. The Generic Drug Market .................................................................................... 20 1. The Hatch-Waxman Act .......................................................................... 20 2. The Importance Of Generic Drugs ......................................................... 21 3. The Players In The Drug Distribution System ........................................ 22 a. Manufacturers/Suppliers ............................................................. 22 b. Wholesalers/Distributors ............................................................ 25 c. Group Purchasing Organizations (GPOs) .................................. 26 d. Pharmacy and supermarket Chains ............................................ 26 e. Customer Incentives .................................................................... 27 4. The Cozy Nature Of The Industry And Opportunities For Collusion ..... 29 a. Trade Association and Customer Conferences ........................... 29 b. Industry Dinners and Private Meetings ...................................... 30 5. The Overarching Conspiracy Between Generic Drug Manufacturers Playing Nice In The Sandbox ................................................................. 33 6. Generic Drug Price Spikes Since 2013 .................................................... 50 C. The Illegal Schemes ............................................................................................. 51 1. The Overarching Conspiracy In Operation: Customer And Market Allocation Agreements To Maintain Market Share And Avoid Price Erosion .................................................................................................... 51 a. Teva/Mylan ................................................................................. 52 i. Fenofibrate ...................................................................... 52 ii. Clonidine –TTS Patch ..................................................... 55 iii. Tolterodine Extended Release ......................................... 60 iv. Capecitabine .................................................................... 65 i b. Teva/Sandoz ................................................................................ 68 i. Portia and Jolessa ............................................................ 68 ii. Temozolomide ................................................................ 70 iii. Tobramycin ..................................................................... 74 iv. Dexmethylphenidate HCL Extended Release ................. 76 c. Teva/Lupin .................................................................................. 79 i. Lamivudine/Zidovudine (generic Combivir) .................. 79 ii. Irbesartan ......................................................................... 83 iii. Drospirenone and ethinyl estradiol (Ocella) ................... 84 iv. Norethindrone/ethinyl estradiol (Balziva®) ................... 88 d. Teva/Greenstone .......................................................................... 88 i. Oxaprozin Tablets ........................................................... 89 ii. Tolterodine Tartrate ....................................................... 92 iii. Piroxicam ....................................................................... 94 iv. Cabergoline .................................................................... 97 e. Teva/Actavis ................................................................................ 98 i. Amphetamine/Dextroamphetamine Extended Release ....... 98 ii. Amphetamine/Dextroamphetamine Immediate Release ..... 99 iii. Dextroamphetamine Sulfate Extended Release ................. 101 iv. Clonidine-TTS ................................................................... 101 v. Budesonide Inhalation ....................................................... 103 vi. Celecoxib ........................................................................... 104 f. Teva/Par .................................................................................... 106 i. Omega-3-Acid Ethyl Esters .......................................... 106 ii. Entecavir ....................................................................... 108 iii. Budesonide DR Capsules .............................................. 110 iv. Clonidine-TTS .............................................................. 101 v. Budesonide Inhalation .................................................. 103 g. Teva/Taro .................................................................................. 112 i. Enalapril Maleate .......................................................... 112 ii. Nortriptyline Hydrochloride ......................................... 116 h. Teva/Zydus ............................................................................... 120 i. Fenofibrate .................................................................... 120 ii. Paricalcitol .................................................................... 125 iii. Niacin ER ...................................................................... 128 iv. Etodolac Extended Release ........................................... 131 i. Teva/Glenmark ......................................................................... 133 i. Moexipril Hydrochloride Tablets ................................. 134 ii. Desogestrel/Ethinyl Estradiol Tables (Kariva) ............. 135 iii. Gabapentin Tablets ....................................................... 136 ii iv. Etodolac Extended Release ........................................... 131 j. Teva/Lannett ............................................................................. 137 i. Baclofen ........................................................................ 138 k. Teva/Amneal ............................................................................. 140 i. Norethindrone Acetate .................................................. 140 l. Teva/Dr. Reddy’s ...................................................................... 141 i. Oxaprozin ...................................................................... 141 ii. Paricalcitol .................................................................... 143 2. Taking The Overarching Conspiracy To A New Level: Price Fixing (2012 – 2015) ....................................................................................... 148 a. Teva July 31, 2012 Price Increase ............................................ 150 i. Nadolol .......................................................................... 151 ii. Labetalol ....................................................................... 154 iii. Nitrofurantoin MAC Capsules ...................................... 154 b. Increasing Prices Before A New Competitor Enters The Market: Budesonide Inhalation Suspension (February – April 2013) ............................................................ 155 c. Early 2013: Teva’s Generics Business Struggles ..................
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