DOCSLIB.ORG

In the United States District Court for the District of Delaware

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
In the United States District Court for the District of Delaware Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 1 of 11 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GILEAD SCIENCES, INC., ) ) Plaintiff, ) ) v. ) C.A. No. ) MYLAN PHARMACEUTICALS INC., ) ) Defendant. ) COMPLAINT FOR PATENT INFRINGEMENT Plaintiff Gilead Sciences, Inc. (“Plaintiff”) brings this Complaint for patent infringement against Defendant Mylan Pharmaceuticals Inc. (“Mylan”) and alleges as follows: NATURE OF THE ACTION 1. This is a civil action for patent infringement by Mylan of U.S. Patent No. 8,148,374 (“the ’374 Patent”), arising under the patent laws of the United States, 35 U.S.C. § 100 et seq., and, more particularly 35 U.S.C. §§ 271(a), (b), (c), (e), and 281. This action relates to the Abbreviated New Drug Application (“ANDA”) No. 208982, filed by Mylan with the United States Food and Drug Administration (“FDA”) for approval to market generic versions of Gilead Sciences, Inc.’s Tybost® (cobicistat tablets) drug product prior to the expiration of the ’374 Patent. PARTIES 2. Plaintiff Gilead Sciences, Inc. is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 333 Lakeside Drive, Foster City, California 94404. 3. On information and belief, Defendant Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of West Virginia, having a principal place of Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 2 of 11 PageID #: 2 business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. On information and belief, Mylan is in the business of, among other things, manufacturing and selling generic copies of branded pharmaceutical products for the United States market. 4. On information and belief, and consistent with its practice with respect to other generic products, Mylan will act to distribute and sell its generic cobicistat tablet drug product that is the subject of ANDA No. 208982 (“Defendant’s ANDA Product”) throughout the United States, including within Delaware. On information and belief, Mylan knows and intends that Defendant’s ANDA Product will be distributed and sold in the United States, including within Delaware. JURISDICTION AND VENUE 5. This action arises under the patent laws of the United States of America. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a). 6. On information and belief, this Court has personal jurisdiction over Mylan because Mylan has purposefully availed itself of the benefits and protections of Delaware’s laws, such that Mylan should reasonably anticipate being haled into court in Delaware. On information and belief, Mylan has had persistent and continuous contacts within this judicial district, including developing, manufacturing, and/or selling pharmaceutical products that are sold in this judicial district. 7. On information and belief, Mylan is in the business of, among other things, formulating, developing, manufacturing, packaging, marketing, and selling generic copies of branded pharmaceutical products for the United States market, including in Delaware. On information and belief, Mylan, directly or through its affiliates and agents, formulates, 2 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 3 of 11 PageID #: 3 manufactures, packages, markets, and/or sells pharmaceutical products throughout the United States and in Delaware. 8. On information and belief, Mylan derives substantial revenue from selling generic pharmaceutical products throughout the United States, including in this judicial district. 9. On information and belief, Mylan is registered with the Delaware Board of Pharmacy as a “Pharmacy-Wholesale[r]” (License No. A4-0001719) and a “Distributor/Manufacturer CSR” (License No. DM-0007571). See Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., 78 F. Supp. 3d 572, 593 (D. Del. 2015). 10. On information and belief, Mylan is registered to do business in Delaware under Delaware’s Business Registration Statute, 8 Del. C. §§ 371 and 376 (2010), and has thereby consented to suit in Delaware. Id. at 587-91. 11. On information and belief, Mylan has appointed Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808, as its registered agent for receipt and service of process. 12. On information and belief, Mylan either sells its generic pharmaceuticals directly into Delaware or has a network of independent wholesalers and distributors with which it contracts to market generic pharmaceutical products in Delaware. See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., Nos. 2015-1456, -1460, slip op. at 15 (Fed. Cir. Mar. 18, 2016). 13. This suit arises out of Mylan’s ANDA filing, “which is a prerequisite to obtaining FDA approval, which is necessary in order to sell Mylan’s Generic Product in the United States, including in Delaware.” Acorda, 78 F. Supp. 3d at 593. 14. This Court has repeatedly exercised jurisdiction over Mylan in prior cases under the Hatch-Waxman Act. See, e.g., Memorandum, Novartis Pharm. Corp. v. Mylan Inc., No. 14- 3 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 4 of 11 PageID #: 4 cv-820-RGA (D. Del. Mar. 16, 2015); Report & Recommendation, Forest Labs., Inc. v. Amneal Pharm. LLC, No. 14-cv-508-LPS (D. Del. Feb. 26, 2015); Opinion, Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., No. 14-cv-935-LPS (D. Del. Jan. 14, 2015); Opinion, AstraZeneca AB v. Mylan Pharm., Inc., No. 14-cv-696-GMS (D. Del. Nov. 5, 2014). See also Acorda, slip op. at 12-13 (discussing why “litigation authorized by § 271(e)(2) and (5) meets Article III’s requirement of a case or controversy”). 15. On information and belief, Mylan has “litigated, as a defendant, over 50 other civil actions initiated in this jurisdiction in the last 19 years and affirmatively invoked this Court’s jurisdiction by asserting counterclaims in at least 46 of those cases.” See Acorda, 78 F. Supp. 3d at 577-78 (internal quotation marks omitted). 16. Mylan also engaged in Delaware-related activities in connection with its efforts to obtain FDA approval to market Defendant’s ANDA Product. On information and belief, Mylan sent a letter dated February 16, 2016 to Plaintiff Gilead Sciences, Inc., a corporation organized under the laws of the State of Delaware, stating that Mylan had submitted ANDA No. 208982 seeking approval to commercially manufacture, use, import, offer for sale, and sell Defendant’s ANDA Product prior to the expiration of the ’374 Patent. If Mylan succeeds in obtaining FDA approval, it would sell Defendant’s ANDA Product in Delaware and other states, causing injury to Plaintiff Gilead Sciences, Inc. in Delaware. See Acorda, slip op. at 8-9, 12-13. 17. On information and belief, Mylan has actual and constructive knowledge that Plaintiff Gilead Sciences, Inc. is a Delaware corporation. 18. On information and belief, Mylan has previously invoked this Court’s jurisdiction, or has stipulated and/or consented to personal jurisdiction in this district, including in prior patent cases. 4 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 5 of 11 PageID #: 5 19. On information and belief, Mylan litigates patent cases in federal courts as part of its business model as a manufacturer of generic drugs, including in this judicial district—where the highest percentage of all Hatch-Waxman cases were filed in the past five years. See Acorda, 78 F. Supp. 3d at 594 n.21; see also Acorda, slip op. at 16. 20. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c), and 1400(b). BACKGROUND 21. On April 3, 2012, the United States Patent and Trademark Office issued the ’374 Patent, entitled “Modulators of Pharmacokinetic Properties of Therapeutics.” A true and correct copy of the ’374 Patent is attached hereto as Exhibit A. 22. Plaintiff Gilead Sciences, Inc. is the assignee of the ’374 Patent, and holds title to the ’374 Patent. 23. The ’374 Patent claims compounds (along with their stereoisomers) and their associated salts and compositions, as well as methods for using the compounds. Cobicistat is one of the compounds claimed in the ’374 Patent. 24. Plaintiff Gilead Sciences, Inc. is the holder of approved New Drug Application (“NDA”) No. 203094 for 150 mg tablets of cobicistat, which is sold under the trade name Tybost®. Tybost® is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. 25. Tybost® is included in FDA’s list of “Approved Drug Products With Therapeutic Equivalence Evaluations,” also known as the “Orange Book.” Approved drugs in the Orange Book may be used as the basis of an applicant’s ANDA to obtain approval of the generic drug product under the provisions of 21 U.S.C. § 355(j). 5 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 6 of 11 PageID #: 6 26. The Orange Book lists patents that the NDA holder asserts cover the approved drug product. The ’374 Patent is listed in the Orange Book in association with Tybost®. The ’374 Patent claims cover Tybost®. 27. On information and belief, Mylan submitted ANDA No. 208982 to the FDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j), seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Defendant’s ANDA Product—a generic version of Tybost®. 28. On information and belief, Mylan continues to seek approval of ANDA No. 208982 from the FDA and intends to engage in the marketing, commercial manufacture, use, offer for sale, sale, and/or importation of Defendant’s ANDA Product (including the commercial marketing and sale of Defendant’s ANDA Product in the State of Delaware) if the FDA approves ANDA No.
Load more

Recommended publications
  • United States Court of Appeals for The
    Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page1 of 37 14‐4353‐cv Apotex Inc., et al., v. Acorda Therapeutics, Inc. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term, 2015 (Argued: November 12, 2015 Decided: May 16, 2016) Docket No. 14‐4353‐cv ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x APOTEX INC., et al., Plaintiffs‐Appellants, ‐ v.‐ ACORDA THERAPEUTICS, INC., Defendant‐Appellee. ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐x Before: JACOBS, LIVINGSTON and DRONEY, Circuit Judges. This appeal concerns two distinct questions: the circumstances under which the filing of a citizen petition with the Food and Drug Administration provides grounds for an antitrust claim, and the scope of false advertising Case 14-4353, Document 100-1, 05/16/2016, 1772362, Page2 of 37 liability under the Lanham Act. Plaintiffs Apotex Incorporated and Apotex Corporation appeal from the judgment of the United States District Court for the Southern District of New York (Swain, J.) that granted defendant Acorda Therapeutics, Inc.’s motion to dismiss plaintiffs’ Sherman Act claim and that granted summary judgment in favor of defendant on the Lanham Act claims (Torres, J.). Because each of these conclusions was sound, we affirm. KEITH D. PARR (with Joseph N. Froehlich, Scott B. Feder, Hugh S. Balsam, James T. Peterka, and Andy J. Miller on the brief), Locke Lord LLP, Chicago, Illinois, for Appellants Apotex Incorporated & Apotex Corporation. JOHN W. NIELDS, JR. (with Jason C. Raofield and Colin P. Watson on the brief), Covington & Burling LLP, Washington, D.C. for Appellee Acorda Therapeutics, Inc. DENNIS JACOBS, Circuit Judge: The parties are rival manufacturers of tizanidine, a drug for treating spasticity.
    [Show full text]
  • Companies in Attendance
    COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology,
    [Show full text]
  • FDA Listing of Authorized Generics As of July 1, 2021
    FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc.
    [Show full text]
  • Fidelity® Nasdaq Composite Index® Fund
    Fidelity® Nasdaq Composite Index® Fund Semi-Annual Report May 31, 2021 Contents Note to Shareholders 3 Investment Summary 4 Schedule of Investments 6 Financial Statements 85 Notes to Financial 89 Statements Shareholder Expense 97 Example Board Approval of 98 Investment Advisory Contracts and Management Fees Liquidity Risk 106 Management Program To view a fund’s proxy voting guidelines and proxy voting record for the 12-month period ended June 30, visit http://www.fidelity.com/proxyvotingresults or visit the Securities and Exchange Commission’s (SEC) web site at http://www.sec.gov. You may also call 1-800-544-8544 to request a free copy of the proxy voting guidelines. Nasdaq®, OMX®, NASDAQ OMX®, Nasdaq Composite®, and The Nasdaq Stock Market®, Inc. are registered trademarks of The NASDAQ OMXGroup, Inc. (which with its Affiliates are the Corporations) and are licensed for use by Fidelity. The product has not been passed on by the Corporations as to its legality or suitability. The product is not issued, endorsed or sold by the Corporations. The Corporations make no warranties and bear no liability with respect to shares of the product. Standard & Poor’s, S&P and S&P 500 are registered service marks of The McGraw-Hill Companies, Inc. and have been licensed for use by Fidelity Distributors Corporation. Other third-party marks appearing herein are the property of their respective owners. All other marks appearing herein are registered or unregistered trademarks or service marks of FMR LLC or an affiliated company. © 2021 FMR LLC. All rights reserved. This report and the financial statements contained herein are submitted for the general information of the shareholders of the Fund.
    [Show full text]
  • Tuesday, November 29 Track One Villard, 2Nd Floor Track Two
    Tuesday, Track One Track Two Track Three Track Four Track Five Track Six Track Seven November 29 Villard, 2nd Floor Spellman, 5th Floor Holmes 1, 4th Floor Holmes 2, 4th Floor Hubbard 1, 5th Floor Kennedy 1, 4th Floor Kennedy 2, 4th Floor Public & Private Track Private Track Registration - Villard Foyer, 2nd Floor 7:30 Continental Breakfast - Reid Salon, 2nd Floor 7:30 DentalPlans.com, Inc. SYMIC BIO, INC. Luminex Corporation Insmed Incorporated AngioDynamics Inc. Vascular Biogenics Ltd. 7:30-7:55 ConforMIS, Inc. (CFMS) (LMNX) (INSM) (ANGO) (VBLT) 7:50 OticPharma, Ltd. Accera, Inc. Gilead Sciences, Inc. Medidata Solutions, Inc. Horizon Pharma plc NxStage Medical, Inc. Acorda Therapeutics, UDG Healthcare plc 8:00-8:25 8:10 Availity, LLC (GILD) (MDSO) (HZNP) (NXTM) Inc. (ACOR) (UDG LN) MiMedx Group, Inc. 8:30 VisionGate, Inc. Boston Scientific Masimo Corporation COMPANY TO BE (MDXG) 8:30-8:55 Akorn, Inc. (AKRX) Teladoc, Inc. (TDOC) Corporation (BSX) (MASI) ANNOUNCED (JS) Anika Therapeutics Inc. 8:50 Benvenue Medical, Inc. (ANIK) Supernus Zimmer Biomet Henry Schein, Inc. Benefitfocus, Inc. Stealth BioTherapeutics 9:00-9:25 Pharmaceuticals, Inc. Ignyta, Inc. (RXDX) 9:10 EarLens Corporation Holdings, Inc. (ZBH) (HSIC) (BNFT) Incorporated (SUPN) Schedule for Tuesday, November 29, 2016 - Page 1 of 10 Schedule as of November 18, 2016. Schedule is subject to change. Tuesday, Track One Track Two Track Three Track Four Track Five Track Six Track Seven November 29 Villard, 2nd Floor Spellman, 5th Floor Holmes 1, 4th Floor Holmes 2, 4th Floor Hubbard 1, 5th Floor Kennedy 1, 4th Floor Kennedy 2, 4th Floor ProMetic Life Sciences Adamas 9:30 Graybug Vision, Inc.
    [Show full text]
  • Deal Point Data Rankings Include Mergers & Acquisitions With
    Public Mergers & Acquisitions (US & Non-US Targets) Deal Point Data rankings include mergers & acquisitions with a US or non-US public target and at least one SEC filer participant. Top Target and Acquirer M&A Financial Advisers Created: 10/Aug/2016 www.dealpointdata.com/ranking Search Criteria Target industry: Healthcare Include only highest bid in pending competing deals. Exclude withdrawn deals. Equity Value Equity Value Equity Value % Rank Rank Advice or Opinion $m $m Change Deal Count Deal Count 2016 2015 Financial Adviser 2016 2015 2015 to 2016 2016 2015 1 7 Evercore Partners 44,102 32,317 36 5 2 2 10 Guggenheim Partners 33,859 18,844 80 5 4 3 15 Bank of America Merrill Lynch 26,599 3,442 673 3 1 4 1 JPMorgan 23,628 68,999 -66 9 10 5 5 Centerview Partners LLC 13,542 42,693 -68 4 5 6 21 Rothschild Inc. 7,160 1,364 425 1 1 Skandinaviska Enskilda Banken 6 - AB 7,160 - - 1 0 8 8 Barclays 5,191 30,919 -83 2 1 9 4 Citigroup Inc. 4,767 46,899 -90 2 7 10 - Perella Weinberg Partners 1,891 - - 4 0 11 19 MTS Health Partners, L.P. 1,634 1,398 17 2 1 12 19 Credit Suisse 1,432 1,398 2 1 1 13 - RBC Capital Markets 1,285 - - 1 0 14 3 Goldman, Sachs & Co. 1,082 53,432 -98 1 9 15 2 Morgan Stanley 714 66,510 -99 1 4 16 - Duff & Phelps, LLC 391 - - 1 0 17 8 Lazard 349 30,919 -99 1 4 18 30 Roth Capital Partners, LLC 264 46 474 1 1 Stifel, Nicolaus & Company, 19 - Incorporated 141 - - 1 0 20 12 Jefferies LLC 85 6,750 -99 1 3 21 - PJT Partners 75 - - 1 0 22 - KPMG 60 - - 1 0 23 - Greenhill and Co 43 - - 1 0 24 - Oppenheimer & Co.
    [Show full text]
  • In the United States District Court for the District Of
    IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC;, et al., ) ) Plaintiffs, ) ) v. ) Civ. No. 15-960-SLR ) MYLAN INC., et al., ) ) Defendants. ) ) Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of Morris Nichols, Arsht & Tunnell LLP, Wilmington, Delaware. Counsel for Plaintiffs. David E. Moore, Esquire, Bindu A. Palapura, Esquire, and Stephanie E. O'Byrne, Esquire of Potter Anderson & Corroon LLP, Wilmington, Delaware. Counsel for Defendants. Of Counsel: Robert L. Florence, Esquire, Karen L. Carroll, Esquire, and Micheal L. Binns, Esquire, Melanie Black Dubis, Esquire of Parker, Poe, Adams & Bernstein LLP. MEMORANDUM OPINION Dated: August \} , 2016 Wilmington, Delaware ROBINSON~ I. INTRODUCTION On October 22, 2015, Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM C.V., ~nd Pfizer Manufacturing Holdings LLC, (collectively "plaintiffs") filed a complaint alleging infringement of three patents related to its injectable antibiotic product TYGACIL ® ("Tygacil") against defendants Mylan Inc., Mylan N.V., Mylan Laboratories Ltd. ("MLL"), and Mylan Pharmaceuticals ("MPI") (collectively "defendants"). (D.I. 1) Presently before the court is defendants' motion to dismiss for lack of personal jurisdiction and improper venue. (D.I. 6) Defendants Mylan Inc., Mylan N.V., and MPI have also filed a motion dismiss for failure to state a claim. (Id.) The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331 and 1338(a). II. BACKGROUND A. The parties Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the State of Delaware with a principal place of business in New York, New York. (D.I. 1 at~ 2) Plaintiff Wyeth LLC is a Delaware limited liability company with a principal place of business in New York, New York.
    [Show full text]
  • 05/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 04:25:50 Report Id 2794D052 Page: 01
    MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 05/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 04:25:50 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 07/01/2016 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 55513 AMGEN USA 00074 ABBOTT LABORATORIES 58406 AMGEN/IMMUNEX 68817 ABRAXIS BIOSCIENCE, LLC 53746 AMNEAL PHARMACEUTICALS 16729 ACCORD HEALTHCARE INCORPORATED 65162 AMNEAL PHARMACEUTICALS LLC 42192 ACELLA PHARMACEUTICALS, LLC 69238 AMNEAL PHARMACEUTICALS, LLC 10144 ACORDA THERAPEUTICS, INC. 53150 AMNEAL-AGILA, LLC 00472 ACTAVIS 00548 AMPHASTAR PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 69918 AMRING PHARMACEUTICALS, INC. 45963 ACTAVIS INC. 66780 AMYLIN PHARMACEUTICALS, INC. 46987 ACTAVIS KADIAN LLC 55724 ANACOR PHARMACEUTICALS 49687 ACTAVIS KADIAN LLC 10370 ANCHEN PHARMACEUTICALS, INC. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 43595 ANGELINI PHARMA, INC. 61874 ACTAVIS PHARMA, INC. 62559 ANIP ACQUISITION COMPANY 67767 ACTAVIS SOUTH ATLANTIC 54436 ANTARES PHARMA, INC. 66215 ACTELION PHARMACEUTICALS U.S., INC. 52609 APO-PHARMA USA, INC. 52244 ACTIENT PHARMACEUTICALS 60505 APOTEX CORP. 75989 ACTON PHARMACEUTICALS 63323 APP PHARMACEUTICALS, LLC. 69547 ADAPT PHARMA INC. 43485 APRECIA PHARMACEUTICALS COMPANY 76431 AEGERION PHARMACEUTICALS, INC. 42865 APTALIS PHARMA US, INC 50102 AFAXYS, INC. 58914 APTALIS PHARMA US, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 13310 AR SCIENTIFIC, INC. 27241 AJANTA PHARMA LIMITED 08221 ARBOR PHARM IRELAND LIMITED 17478 AKORN INC 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 24090 AKRIMAX PHARMACEUTICALS LLC 24338 ARBOR PHARMACEUTICALS, INC. 68220 ALAVEN PHARMACEUTICAL, LLC 59923 AREVA PHARMACEUTICALS 00065 ALCON LABORATORIES, INC. 76189 ARIAD PHARMACEUTICALS, INC. 00998 ALCON LABORATORIES, INC. 24486 ARISTOS PHARMACEUTICALS, INC.
    [Show full text]
  • Rebateable Manufacturers
    Rebateable Labelers – July 2021 Manufacturers are responsible for updating their eligible drugs and pricing with CMS. Montana Healthcare Programs will not pay for an NDC not updated with CMS. Note: Some manufacturers on this list may have some NDCs that are covered and others that are not. Manufacturer ID Manufacturer Name 00002 ELI LILLY AND COMPANY 00003 E.R. SQUIBB & SONS, LLC. 00004 HOFFMANN-LA ROCHE 00006 MERCK & CO., INC. 00007 GLAXOSMITHKLINE 00008 WYETH PHARMACEUTICALS LLC, 00009 PHARMACIA AND UPJOHN COMPANY LLC 00013 PFIZER LABORATORIES DIV PFIZER INC 00015 MEAD JOHNSON AND COMPANY 00023 ALLERGAN INC 00024 SANOFI-AVENTIS, US LLC 00025 PFIZER LABORATORIES DIV PFIZER INC 00026 BAYER HEALTHCARE LLC 00032 ABBVIE INC. 00037 MEDA PHARMACEUTICALS, INC. 00039 SANOFI-AVENTIS, US LLC 00046 WYETH PHARMACEUTICALS INC. 00049 ROERIG 00051 ABBVIE INC 00052 ORGANON USA INC. 00053 CSL BEHRING L.L.C. 00054 HIKMA PHARMACEUTICAL USA, INC. 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00065 ALCON LABORATORIES, INC. 00068 AVENTIS PHARMACEUTICALS 00069 PFIZER LABORATORIES DIV PFIZER INC 00071 PARKE-DAVIS DIV OF PFIZER 00074 ABBVIE INC 00075 AVENTIS PHARMACEUTICALS, INC. 00078 NOVARTIS 00085 SCHERING CORPORATION 00087 BRISTOL-MYERS SQUIBB COMPANY 00088 AVENTIS PHARMACEUTICALS 00093 TEVA PHARMACEUTICALS USA, INC. 00095 BAUSCH HEALTH US, LLC Page 1 of 19 Manufacturer ID Manufacturer Name 00096 PERSON & COVEY, INC. 00113 L. PERRIGO COMPANY 00115 IMPAX GENERICS 00116 XTTRIUM LABORATORIES, INC. 00121 PHARMACEUTICAL ASSOCIATES, INC. 00131 UCB, INC. 00132 C B FLEET COMPANY INC 00143 HIKMA PHARMACEUTICAL USA, INC. 00145 STIEFEL LABORATORIES, INC, 00168 E FOUGERA AND CO. 00169 NOVO NORDISK, INC. 00172 TEVA PHARMACEUTICALS USA, INC 00173 GLAXOSMITHKLINE 00178 MISSION PHARMACAL COMPANY 00185 EON LABS, INC.
    [Show full text]
  • Appendix A: Overview of Selected Collaborations 1
    Appendix A: Overview of Selected Collaborations 1 Appendix A: Overview of Selected Collaborations The following appendix provides an overview of selected biopharmaceutical collaborations to advance efforts focused in the following areas: Research & Development, Public Health & Improving Patient Outcomes, Manufacturing & Distribution, Improving Access. Partnerships were grouped together based on a singular, or in some cases, overlapping focus area. The selected examples below, provide a brief overview of the collaboration’s purpose, partners, approach used to generate results and any successes yielding from the group’s efforts. R&D 3 Antimicrobial Resistance (AMR) Action Fund ____________________________________________________________________ 3 Alzheimer's Disease Neuroimaging Initiative (ADNI) _______________________________________________________________ 3 AstraZeneca’s Open Innovation _______________________________________________________________________________ 4 Lung Cancer Master Protocol (Lung-MAP) ______________________________________________________________________ 7 Multiple Sclerosis Partnership ________________________________________________________________________________ 7 Northeast ALS Consortium __________________________________________________________________________________ 8 One Brave Idea ___________________________________________________________________________________________ 8 Parkinson’s Disease Education Consortium (PDEC) _______________________________________________________________ 9 Rare Disease Cures
    [Show full text]
  • ACORDA THERAPEUTICS, INC. and ALKERMES PHARMA IRELAND LIMITED, Plaintiffs, V
    Page 1 ACORDA THERAPEUTICS, INC. and ALKERMES PHARMA IRELAND LIMITED, Plaintiffs, v. MYLAN PHARMACEUTICALS INC. and MYLAN INC., Defendants. Civil Action No. 14-935-LPS UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE 2015 U.S. Dist. LEXIS 4056 January 14, 2015, Decided January 14, 2015, Filed COUNSEL: For Plaintiffs: Jack B. Blumenfeld and have moved to dismiss the complaint filed against them Maryellen Noreika, MORRIS, NICHOLS, ARSHT & by Plaintiffs Acorda Therapeutics, Inc. ("Acorda") and TUNNELL, LLP, Wilmington, DE; Aaron Stiefel, Daniel Alkermes Pharma Ireland Limited ("Alkermes" and, P. DiNapoli, Benjamin C. Hsing, and Soumitra Deka, together with Acorda, "Plaintiffs"). (D.I. 10) Defendants KAYE SCHOLER, LLP, New York, NY; Sylvia M. bring their motion pursuant to Federal Rule of Civil Becker [*1] , KAYE SCHOLER, LLP, Washington, DC; Procedure 12(b)(2), asserting a lack of personal Anthony Michael, ACORDA THERAPEUTICS, INC., jurisdiction. Specifically, Mylan contends that the Ardsley, NY. Supreme Court's recent decision [*2] in Daimler AG v. Bauman, 134 S. Ct. 746, 187 L. Ed. 2d 624 (2014), has For Defendants: Mary B. Matterer and Richard K. resulted in the District of Delaware lacking general Herrmann, MORRIS JAMES, LLP, Wilmington, DE; jurisdiction over Mylan in this (and likely all)1 Timothy H. Kratz, George J. Barry III, Karen L. Carroll, Abbreviated New Drug Application ("ANDA") lawsuits. and Brie L.B. Buchanan, MCGUIREWOODS, LLP, Mylan further contends that its relationship with Atlanta, GA; Cedric C.Y. Tan, MCGUIREWOODS, Delaware and with this litigation does not support the LLP, Washington, DC. exercise of specific jurisdiction. JUDGES: Leonard P.
    [Show full text]
  • Current Sustaining Member Companies
    CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2018 Coherus Biosciences 2019 Ipsen Biopharmaceuticals, Inc. 2011 Remund Group, LLC 1985 Abbott Laboratories, Inc. 2017 Cook Medical, LLC 2018 IT Cadre 2018 Rigel Pharmaceuticals 2013 AbbVie Inc. 2020 D2 Pharma Consulting, LLC 1989 J & J Health Care Systems, Inc. 2000 Sanofi 2021 Adaptive Biotechnologies 2007 Daiichi Sankyo, Inc. 2014 Jazz Pharmaceuticals Inc. 2020 Seattle Genetics 2017 ACADIA Pharmaceuticals, Inc. 2020 Deciphera Pharmaceuticals, LLC 2007 Karl Storz Endoscopy America 2004 Siemens Medical Solutions 2020 AcelRx Pharmaceuticals, Inc. 2009 Deloitte 2020 Lipogems 2019 SK Life Science, Inc. 2020 Acorda Therapeutics 2020 Dexcom, Inc. 2010 LLC Federal Solutions 2002 Smith & Nephew, Inc. 2019 Aimmune 2020 Drip Drop Hydration 2014 Lovell Government Services LLC 2019 Sobi Inc. 2003 Alcon Laboratories, Inc. 2017 Eagle Pharmaceuticals, Inc. 2014 Mallinckrodt Pharmaceuticals 2013 Stryker Orthopaedics 2019 Alexion Pharmaceuticals, Inc. 2005 Eisai, Inc. 2020 MannKind Corporation 2018 Sun Pharmaceutical 2017 Alkermes, Inc. 2019 electroCore, Inc. 1999 Marketing Assessment, Inc. 1999 Sunovion Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2010 Endo Pharmaceuticals 2009 Masimo Corporation 2016 Taiho Oncology, Inc. 2019 Altarum Institute 2017 Exelixis 2019 Medical Strategies International, LLC 2015 Takeda Oncology 2020 Amarin Corporation 2016 Express Scripts Federal Pharmacy 2016 Melling Medical 2000 Takeda Pharmaceutical USA, Inc. 1994 AmerisourceBergen 2010 Federal Practitioner 1954 Merck & Co., Inc. 2020 Telemynd 1992 Amgen 2018 Foundation Medicine, Inc. 2002 MerzNorth America 2020 TerSera Therapeutics 2020 Amneal Pharmaceutical 2021 Frontier Technology Inc. (FTI) 2018 Mitsubishi Tanabe Pharma America 1990 Teva 2019 Aptive Resources LLC 2020 Fresenius Medical Care North America 2014 Nationwide Pharmaceutical LLC 2019 The Coalition for Government Procurement 2011 Arbor Pharmaceuticals, LLC 1989 Genentech Inc.
    [Show full text]