DOCSLIB.ORG

FDA Listing of Authorized Generics As of July 1, 2021

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read 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. 2 ACCOLATE Tablets 10 mg AstraZeneca 11/19/2010 Pharmaceuticals 3 ACCOLATE Tablets 20 mg AstraZeneca 11/19/2010 Pharmaceuticals 4 ACCUNEB Solution 0.63 mg/3 mL Mylan Specialty 02/2012 L.P. 5 ACCUNEB Solution 1.25 mg/3 mL Mylan Specialty 02/2012 L.P. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 6 ACCURETIC Tablets 10 mg/12.5 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 7 ACCURETIC Tablets 20 mg/12.5 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 8 ACCURETIC Tablets 20 mg/25 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 9 ACEPHEN Suppositories 120 mg G & W Laboratories, Prior to 1/1/1999 Inc. 10 ACETADOTE Injection 6 g/30 mL (200 mg/mL) Cumberland 1/7/2013 Pharmaceuticals, Inc. 11 ACTICLATE Tablets 150 mg Almirall, LLC 02/2018 12 ACTICLATE Tablets 75 mg Almirall, LLC 02/2018 13 ACTIGALL Capsules 300 mg Allergan Sales, LLC 08/13/2003 14 ACTIQ Lozenge 600 mcg Cephalon, Inc. 09/26/2006 15 ACTIQ Lozenge 800 mcg Cephalon, Inc. 09/26/2006 16 ACTIQ Lozenge 400 mcg Cephalon, Inc. 09/26/2006 17 ACTIQ Lozenge 1200 mcg Cephalon, Inc. 09/26/2006 18 ACTIQ Lozenge 1600 mcg Cephalon, Inc. 09/26/2006 19 ACTIQ Lozenge 200 mcg Cephalon, Inc. 09/26/2006 20 ACTIVELLA Tablets 1 mg / 0.5 mg Amneal 01/2019 Pharmaceuticals LLC 21 ACTONEL Tablets 150 mg Warner Chilcott 06/2014 Company LLC NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 22 ACTOS Tablets 15 mg Takeda 08/17/2012 Pharmaceuticals USA 23 ACTOS Tablets 30 mg Takeda 08/17/2012 Pharmaceuticals USA 24 ACTOS Tablets 45 mg Takeda 08/17/2012 Pharmaceuticals USA 25 ACULAR LS Ophthalmic 0.4% Allergan, Inc. 11/11/2013 Solution 26 ACZONE Gel 7.5% Almirall, LLC 01/2020 27 ADDERALL XR Extended- 30 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 28 ADDERALL XR Extended- 25 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 29 ADDERALL XR Extended- 15 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 30 ADDERALL XR Extended- 30 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 31 ADDERALL XR Extended- 20 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 32 ADDERALL XR Extended- 5 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 33 ADDERALL XR Extended- 10 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 34 ADDERALL XR Extended- 10 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 35 ADDERALL XR Extended- 20 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 36 ADDERALL XR Extended- 15 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 37 ADDERALL XR Extended- 25 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 38 ADRENACLICK Injection 0.3 mg Impax Laboratories, 04/01/2010 LLC 39 ADRENACLICK Injection 0.15 mg Impax Laboratories, 04/01/2010 LLC 40 ADVAIR DISKUS Inhalation 500/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England 41 ADVAIR DISKUS Inhalation 100/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 42 ADVAIR DISKUS Inhalation 250/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England 43 AGGRENOX Capsules 25 mg and 200 mg Boehringer 08/2018 Ingelheim Pharmaceuticals, Inc 44 AIRDUO Inhalation 55 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 45 AIRDUO Inhalation 232 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 46 AIRDUO Inhalation 113 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 47 ALBENZA Tablets 200 mg Impax Laboratories, 09/2018 LLC 48 ALDACTAZIDE Tablets 25 mg/25 mg Pfizer Inc. 10/06/2003 49 ALDACTONE Tablets 25 mg Pfizer Inc. 6/18/2003 50 ALDACTONE Tablets 50 mg Pfizer Inc. 6/18/2003 51 ALLEGRA Tablets 30 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 52 ALLEGRA Tablets 60 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 53 ALLEGRA Tablets 180 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 54 ALLEGRA-D 12 Extended- 60 mg/120 mg Sanofi Aventis US 12/2004 - 12/2005 HOUR release Tablets LLC NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 55 AMARYL Tablets 1 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 56 AMARYL Tablets 2 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 57 AMARYL Tablets 4 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 58 AMBIEN Tablets 5 mg Sanofi Aventis US 12/2006 - 12/2007 LLC 59 AMBIEN Tablets 10 mg Sanofi Aventis US 12/2006 - 12/2007 LLC 60 AMBIEN CR Extended- 6.25 mg Sanofi Aventis U.S. 10/2010 release Tablets LLC 61 AMBIEN CR Extended- 12.5 mg Sanofi Aventis U.S. 12/2010 release Tablets LLC 62 AMICAR Tablets 1000 mg Clover 06/01/2012 Pharmaceuticals Corporation 63 AMMONUL Injection 10% / 10% Bausch Health US, 03/2017 LLC 64 AMPYRA Tablets 10 mg Acorda Therapeutics, 09/2018 Inc. 65 AMRIX Capsules 30 mg Cephalon, Inc. 03/2019 66 AMRIX Capsules 15 mg Cephalon, Inc. 03/2019 67 AMRIX Capsules 30 mg Cephalon, Inc. 03/2019 68 AMRIX Capsutls 15 mg Cephalon, Inc. 03/2019 69 ANAFRANIL Capsules 50 mg Mallinckrodt 07/2015 70 ANAFRANIL Capsules 25 mg Mallinckrodt 07/2015 NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 71 ANAFRANIL Capsules 75 mg Mallinckrodt 07/2015 72 ANAPROX DS Tablets 550 mg Atnahs Pharma US 10/2018 Limited 73 ANCOBAN Capsules 250 mg Bausch Health US, 07/2017 LLC 74 ANCOBAN Capsules 500 mg Bausch Health US, 01/17/2012 LLC 75 ANDROGEL Gel 1.62% AbbVie Inc. 11/2019 76 ANGIOMAX Powder, for 250 mg Sandoz Inc. 10/2015 injection solution, lyophilized 77 ANGIOMAX Powder, for 250 mg Sandoz Inc. 02/2017 injection solution, lyophilized 78 ANTARA Capsules 43 mg Lupin, Inc. 02/22/2013 79 ANTARA Capsules 130 mg Lupin, Inc. 02/22/2013 80 APADAZ Tablets 8.16 mg / 325 mg KVK-Tech, Inc. 06/2019 81 APRISO Extended- 375 mg Salix 07/2018 release Pharmaceuticals, Capsules Inc. 82 APTENSIO XR Extended- 15 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 83 APTENSIO XR Extended- 50 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 84 APTENSIO XR Extended- 20 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 85 APTENSIO XR Extended- 30 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 86 APTENSIO XR Extended- 40 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 87 APTENSIO XR Extended- 60 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 88 APTENSIO XR Extended- 10 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 89 ARAVA Tablets 10 mg Sanofi Aventis US 09/07/2015 LLC 90 ARAVA Tablets 20 mg Sanofi Aventis US 09/07/2015 LLC 91 ARICEPT Film coated 5 mg Eisai, Inc. 11/25/2009 - 11/24/2010 tablets 92 ARICEPT Film coated 10 mg Eisai, Inc. 11/25/2009 - 11/24/2010 tablets 93 ARICEPT ODT Orally 10 mg Eisai, Inc. 10/18/2009 - 11/24/2010 disintegrating tablets NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 94 ARICEPT ODT Orally 5 mg Eisai, Inc. 10/18/2009 - 11/24/2010 distinegrating tablets 95 ARIXTRA Injection 5 mg / 0.4 mL Mylan Ireland 12/2014 - 12/2015 Limited 96 ARIXTRA Injection 10 mg / 0.8 mL Mylan Ireland 12/2014 - 12/2015 Limited 97 ARIXTRA Injection 2.5 mg / 0.5 mL Mylan Ireland 12/2014 - 12/2015 Limited 98 ARIXTRA Injection 7.5 mg / 0.6 mL Mylan Ireland 12/2014 - 12/2015 Limited 99 AROMASIN Tablets 25 mg Pharmacia & Upjohn 11/02/2010 LLC 100 ARTHROTEC Tablets 75 mg/200 mcg Pfizer Inc.
Load more

Recommended publications
  • From the Academy
    FROM THE ACADEMY Joint American Academy of DermatologyeNational Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy Craig A. Elmets, MD (Co-Chair),a HenryW.Lim,MD,b Benjamin Stoff, MD, MA,c Cody Connor, MD,a Kelly M. Cordoro, MD,d Mark Lebwohl, MD,e AprilW.Armstrong,MD,MPH,f Dawn M. R. Davis, MD,g Boni E. Elewski, MD,a Joel M. Gelfand, MD, MSCE,h Kenneth B. Gordon, MD,i AliceB.Gottlieb,MD,PhD,j Daniel H. Kaplan, MD, PhD,k Arthur Kavanaugh, MD,l Matthew Kiselica, BA/BS,m Dario Kivelevitch, MD,n Neil J. Korman, MD, PhD,o Daniela Kroshinsky, MD, MPH,p Craig L. Leonardi, MD,q Jason Lichten, MD,m NehalN.Mehta,MD,MSCE,r Amy S. Paller, MD,s Sylvia L. Parra, MD,t Arun L. Pathy, MD,u Elizabeth A. Farley Prater, MD,v Reena N. Rupani, MD,e Michael Siegel, PhD,m BruceE.Strober,MD,PhD,w,x Emily B. Wong, MD,y Jashin J. Wu, MD,z Vidhya Hariharan, PhD,aa and Alan Menter, MD (Co-Chair)n Birmingham, Alabama; Detroit, Michigan; Atlanta, Georgia; San Francisco, Los Angeles, San Diego, and Irvine, California; New York, New York; Rochester, Minnesota; Philadelphia and Pittsburgh, Pennsylva- nia; Milwaukee, Wisconsin; Portland, Oregon; Dallas and San Antonio, Texas; Cleveland, Ohio; Boston, Massachusetts; St. Louis, Missouri; Bethesda, Maryland; Chicago and Rosemont, Illinois; Sumter, South Carolina; Centennial, Colorado; Oklahoma City, Oklahoma; Farmington, Connecticut; and Waterloo, Ontario, Canada Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 3.2% of the world’s population.
    [Show full text]
  • In the United States District Court for the District Of
    IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FOREST LABORATORIES, LLC and ) FOREST LABORATORIES ) HOLDINGS, LTD., ) ) Plaintiffs, ) ) v. ) Civ.No.14-1119-SLR ) SIGMAPHARM LABORATORIES, LLC, ) et al., ) ) Defendants. ) Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware. Counsel for Plaintiffs. Of Counsel: Howard W. Levine, Esquire, Sanya Sukduang, Esquire, Jonathan R. Davies, Esquire, Courtney B. Gasp, Esquire, and Charles E. Lipsey, Esquire of Finnegan, Henderson, Farabow, Garrett & Dunner LLP. John C. Phillips, Esquire, David A. Bilson, Esquire and Megan C. Haney of Phillips, Goldman, Mclaughlin & Hall, P.A., Wilmington, Delaware. Counsel for Defendant Sigmapharm Laboratories, LLC. Of Counsel: Anthony G. Simon, Esquire, Anthony R. Friedman, Esquire, Benjamin R. Askew, Esquire, and Michael P. Kella, Esquire of The Simon Law Firm, P.C. Karen Elizabeth Keller, Esquire and Jeffrey Thomas Castellano, Esquire of Shaw Keller, LLP, Wilmington, Delaware. Counsel for Defendants Hikma Pharmaceuticals LLC, Hikma Pharmaceuticals PLC, and West-Ward Pharmaceutical Corp. Of Counsel: lmron T. Aly, Esquire, Joel M. Wallace, Esquire, and Helen H. Ji, Esquire of Schiff Hardin LLP. Richard D. Kirk, Esquire, Stephen B. Brauerman, Esquire and Sara E. Bussiere, Esquire of Bayard, P.A., Wilmington, Delaware. Counsel for Defendant Breckenridge Pharmaceutical, Inc. Of Counsel: Beth D. Jacob, Esquire, Clifford Katz, Esquire, and Malavika A. Rao, Esquire of Kelley, Drye & Warren LLP. Karen Pascale, Esquire and Pilar G. Kraman, Esquire of Young, Conaway, Stargatt & Taylor, LLP, Wilmington, Delaware. Counsel for Defendants Alembic Pharmaceuticals Ltd., Alembic Global Holding SA and Alembic Pharmaceuticals, Inc. Of Counsel: Steven J. Lee, Esquire, Michael K.
    [Show full text]
  • Abbvie Allergan Acquisition
    Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document.
    [Show full text]
  • Preclinical Development & IND Filing: Nuts, Bolts, Best Practices
    “Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Aspects.” Speakers: Amit Kalgutkar (Pfizer), Chandra Prakash (Agios), Sanjeev Thohan (Novartis), Li- Chun Wang (Takeda), Wei Yin (Biogen) Organizers: Sanjeev Thohan and Chandra Prakash Date: 6/29/2017 Time: 8:30 am – 5.00 pm Location: Boston/Cambridge Area: Marriott Kendall Square, 50 Broadway, Cambridge MA 02142 Fees: $175 - Regular (before June 1st, 2017), $225 - Regular (after June 1st, 2017); $125 - Unemployed & Academic; $2000 - Major Sponsorship; $475 - Vendor Show Registration: www.PBSS.org Workshop Description: An investigational new drug application (IND) is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations and processes of assembling an IND is a key to not only successful filing, but also a promising clinical development path forward. Often there are cases where too many of our “nice-to-have” studies crowd the package at the expense of critical study needs/issues. This can lead to significant delays in clinical developments with back-and-forth of Q&A sessions both internally and with regulatory agencies. As we have seen, the regulatory landscape is changing as rapidly as the industry innovates into new therapeutic modalities. Therefore, it is critical to keep up to date on regulatory requirements and the industry’s best practices in different aspects of the IND: non- clinical safety, PK, CMC, and clinical plans. In this workshop, our speakers who bring years of experience with multiple successful IND filings, will discuss systematically the preclinical studies required for small molecule IND’s as well as the nuts and bolts of putting together a high–quality IND package.
    [Show full text]
  • Print Layout 1
    TECHNICAL PROGRAM Monday, March 19 5:00 – 8:00 pm Welcome Reception Tuesday, March 20 8:00 – 10:00 Session 1: Setting the Conference Context and Drivers Chair: Geoff Slaff (Amgen) Roger Perlmutter (Amgen) Conquering the Innovation Deficit in Drug Discovery Helen Winkle (CDER, FDA) Regulatory Modernization 10:00 – 10:30 Break Vendor and poster review 10:30 – 12:30 Session 2: Rapid Cell Line Development and Improved Expression System Development Chairs: Timothy Charlebois (Wyeth) and John Joly (Genentech) Amy Shen (Genentech) Stable Antibody Production Cell-Line Development with an Improved Selection Process and Accelerated Timeline Mark Leonard (Wyeth) High-Performing Cell-Line Development within a Rapid and Integrated Platform Process Control Pranhitha Reddy (Amgen) Applying Quality-by-Design to Cell Line Development Lin Zhang (Pfizer) Development of a Fully-Integrated Automated System for High-Throughput Screening and Selection of Single Cells Expressing Monoclonal Antibodies 12:30 – 2:00 Lunch Vendor and poster review 2:00 – 4:30 Session 3: High-Throughput Bulk Process Development Chairs: Brian Kelley (Wyeth) and Jorg Thommes (Biogen Idec) Colette Ranucci (Merck) Development of a Multi-Well Plate System for High-Throughput Process Development Min Zhang (SAFC Biosciences) CHO Media Library – an Efficient Platform for Rapid Development and Optimization of Cell Culture Media Supporting High Production of Pharmaceutical Proteins in Chinese Hamster Ovary Cells Nigel Titchener-Hooker The Use of Ultra-Scale-Down Approaches to Enable Rapid Investigation
    [Show full text]
  • Annual Report on Annual Reports 2016
    ANNUAL REPORT ON ANNUAL REPORTS 2016 TOP 400 ANNUAL REPORTS WHO RANKS WHERE? 100 ANNUALS IN BRIEF BEST REPORTING PRACTICES Company Value > Report Value Annual Report on Annual Reports 2016 Contents Report rating scale 3 Top 400 annual reports 4 Who ranks where? 25 From ABB to ZTE 100 annuals in brief 58 From Abbott to Yamaha How important is the annual report today? 92 Views from Cecilia Ketels, Kellie Friery, Renee Carter, David Robinson, Kaevan Gazdar, Elena Moskvina, Thomas Rosenmayr, Rob Stangroom, Andrey Kozhevnikov, Ana Santamarina, Katie Holcomb, Ananda Jagoda Best practices on key report attibutes 100 Strategy, message, investor information, risks, style, online… How we make it 121 How is your report doing? The report scan 127 The report rating panel 128 Robert Berick, Susan Blesener, Renee Carter, Vero Escarmelle, Helena Fournial, Kaevan Gazdar, Mike Guillaume, Pradip Seth, Eva Wolosiuk Making reports pay off 133 e.com – ReportWatch 135 2 Report rating scale A+ ééééé First-rate A éééé(é) Excellent A- éééé Very good B+ ééé(é) Sound B ééé Average B- éé(é) Uneven C+ éé Common C é(é) Substandard C- é Poor D (é) Uncompetitive 3 Top 400 annual reports AkzoNobel (No. 1) Electrolux (No. 2 ) SCA (No. 3) Volvo (No. 4) 4 Report rank Company Country Report rating Compare 1 AKZONOBEL Netherlands A+ DUPONT 2 ELECTROLUX Sweden A+ WHIRLPOOL 3 SCA Sweden A+ KIMBERLY-CLARK 4 VOLVO Sweden A+ DAIMLER 5 POTASHCORP Canada A+ AGRIUM 6 ATLAS COPCO Sweden A SANDVIK 7 STORA ENSO Finland A UPM 8 BOLIDEN Sweden A GLENCORE 9 WIENERBERGER Austria A BORAL 10
    [Show full text]
  • XCHANGE COMMISSION Washington, D.C
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (X) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 ( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 0-19034 REGENERON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) New York 13-3444607 (State or other jurisdiction of (I.R.S. Employer Identification No) incorporation or organization) 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 (Address of principal executive offices) (Zip code) (914) 347-7000 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: None (Title of Class) Securities registered pursuant to Section 12(g) of the Act: Common Stock - par value $.001 per share (Title of Class) Preferred Share Purchase Rights expiring October 18, 2006 (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes /X/ No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (ss. 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
    [Show full text]
  • Faculty Disclosure
    Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences,
    [Show full text]
  • Virginia: in the Circuit Court of Pittsylvania County
    VIRGINIA: IN THE CIRCUIT COURT OF PITTSYLVANIA COUNTY PITTSYLVANIA COUNTY, Plaintiff, v. PURDUE PHARMA, L.P.; PURDUE PHARMA, INC.; THE PURDUE FREDERICK COMPANY, INC.; RHODES PHARMACEUTICALS, L.P.; ABBOTT LABORATORIES; ABBOTT LABORATORIES, INC.; MALLINCKRODT PLC; MALLINCKRODT LLC; ENDO HEALTH SOLUTIONS, INC; ENDO PHARMACEUTICALS, INC.; PAR Case No. CL18 - __________ PHARMACEUTICAL COMPANIES, INC.; PAR PHARMACEUTICAL, INC.; TEVA Jury Trial Demanded PHARMACEUTICALS USA, INC.; CEPHALON, INC.; BARR LABORATORIES, INC.; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC.; WATSON LABORATORIES, INC.; ALLERGAN PLC; ACTAVIS PHARMA, INC.; ACTAVIS, LLC; INSYS THERAPEUTICS, INC.; KVK-TECH, INC.; AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC; AMNEAL PHARMACEUTICALS, INC.; AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; MYLAN PHARMACEUTICALS, INC.; MCKESSON CORPORATION; MCKESSON MEDICAL-SURGICAL INC.; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN DRUG CORPORATION; HENRY SCHEIN, INC.; GENERAL INJECTABLES & VACCINES, INC.; INSOURCE, INC.; CVS HEALTH CORPORATION; CVS PHARMACY, INC.; CVS TN DISTRIBUTION, L.L.C.; WALGREENS BOOTS ALLIANCE, INC.; WALGREEN CO.; EXPRESS SCRIPTS HOLDING COMPANY; EXPRESS SCRIPTS, INC; CAREMARK RX, L.L.C.; CAREMARKPCS HEALTH, L.L.C.; CAREMARK, L.L.C.; UNITEDHEALTH GROUP INCORPORATED; OPTUM, INC.; OPTUMRX, INC.; and DOES 1-100, Defendants. PLAINTIFF’S ORIGINAL COMPLAINT Plaintiff, Pittsylvania County, Virginia, by and through the undersigned attorneys, (hereinafter “Plaintiff,” “Pittsylvania
    [Show full text]
  • 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]
  • Q1 Pharma Sector Snapshot
    SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor
    [Show full text]
  • The Covid–19 Pandemic and Haemoglobin Disorders
    THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’.
    [Show full text]