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RxOutlook® 1st Quarter 2017 OptumRx brand pipeline forecast Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date 2017 Possible launch date arbaclofen extended- Ontinua ER Osmotica muscle relaxant Spasticity PO Filed NDA 2017 Y N release Xeglyze abametapir Hatchtech metalloprotease inhibitor Lice TOP Filed NDA 2017 N N Dr. Reddy's Tentative Zenavod doxycycline tetracyclines Rosacea PO 2017 N N Laboratories Approval Remodulin Implantable Pulmonary arterial treprostinil United Therapeutics prostacyclin analog IV/SC Filed sNDA 2017+ Y Y System hypertension SER-120 desmopressin Allergan/Serenity antidiuretic Nocturia Intranasal Filed NDA 1Q2017 N N Amphora Amphora Evofem spermicidal agent Pregnancy prevention VG Filed NDA 1Q2017 N N sodium glucose co- empagliflozin/ empagliflozin/ Boehringer Ingelheim transporter-2 (SGLT-2) Diabetes mellitus PO Filed NDA 1Q2017 N N metformin ER metformin ER inhibitor/biguanide promethazine/ Charleston CL-108 hydrocodone/ anti-emetic/opioid/analgesic Nausea/Vomiting/Pain PO Filed NDA 1/31/2017 N N Laboratories acetaminophen etelcalcetide Parsabiv (velcalcetide, Amgen calcimimetic Hyperparathyroidism IV Filed NDA 2/9/2017 Y N telcalcetide) Duchenne muscular MP-104 deflazacort Marathon corticosteroid PO Filed NDA 2/9/2017 Y Y dystrophy optum.com/optumrx 1 RxOutlook® 1st Quarter 2017 Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date ALK-Abello (HDM AIT, Abbott/ALK- Mitizax vaccine Dust mite allergic rhinitis SL Filed BLA 2/10/2017 N N MK-8237) Abello/Torii AstraZeneca/ interleukin-17 (IL-17) receptor Siliq brodalumab Psoriasis/Psoriatic arthritis SC Filed BLA 2/16/2017 Y N Valeant inhibitor naloxone naloxone Amphastar opioid antagonist Opioid dependence Intranasal Filed NDA 2/19/2017 N N tryptophan hydroxylase telotristat etiprate telotristat etiprate Lexicon Carcinoid syndrome PO Filed NDA 2/28/2017 Y Y antagonist Non-small cell lung cancer FastTrk/ MVA-MUC1-IL2 TG-4010 Transgene vaccine SC 12/1/2017 N N (NSCLC) Breakthru Xadago safinamide Newron alpha-aminoamide derivative Parkinson's disease PO Filed NDA 3/21/2017 N N Symproic naldemedine Shionogi/Purdue opioid receptor antagonist Opioid-induced constipation PO Filed NDA 3/23/2017 N N dexamethasone Dextenza Ocular Therapeutix corticosteroid Pain/Allergic conjunctivitis OP Filed NDA 3/24/2017 N N sustained-release anti-CD20 monoclonal Ocrevus ocrelizumab Genentech Multiple sclerosis IV Filed BLA 3/28/2017 Y N antibody Atopic dermatitis (AD)/ interleukin-4/13 (IL-4/IL-13) Asthma/Sinusitis/Nasal Dupixent dupilumab Sanofi/Regeneron SC Filed BLA 3/29/2017 Y N inhibitor polyposis/Eosinophilic esophagitis Regeneron/Sanofi- anti-interleukin-6 receptor (IL- sarilumab (REGN-88) sarilumab Rheumatoid arthritis/Uveitis SC CRL 3/30/2017 Y N Aventis 6R) monoclonal antibody human parathyroid hormone- abaloparatide-SC abaloparatide-SC Radius related protein (hPTHrP) Osteoporosis SC Filed NDA 3/30/2017 Y N analog Primary immunodeficiency/ RI-002 RI-002 ADMA Biologics immunoglobulin Respiratory syncytial virus IV CRL 2Q2017 Y N (RSV)/Bacterial infections optum.com/optumrx 2 RxOutlook® 1st Quarter 2017 Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date AC-170 cetirizine Nicox antihistamine Allergic conjunctivitis TOP CRL 2Q2017 N N sodium zirconium ZS-9 ZS Pharma potassium-binding agent Hyperkalemia PO Filed NDA 2Q2017 N N cyclosilicate Acute lymphoblastic leukemia (ALL)/Diffuse large chimeric antigen receptor FastTrk/ CTL-019 CTL-019 Novartis B-cell lymphoma IV 2Q2017 Y Y (CAR) T cell therapy Breakthru (DLBCL)/Chronic lymphocytic leukemia (CLL) ACH-3102 (ACH- FastTrk/ odalasvir Achillion NS5A inhibitor Hepatitis C (HCV) PO 2Q2017 Y N 0143102) Breakthru N9-GP (NN-7999, NNC- 0156-0000-0009, PEG- nonacog beta pegol Novo Nordisk coagulation factor Hemophilia IV Filed BLA 2Q2017 Y Y rFIX) Bladder cancer/Non-small AstraZeneca/ cell lung cancer (NSCLC)/ durvalumab durvalumab Celgene/Eli Lilly/ anti-PDL-1 antibody IV Filed BLA 2Q2017 Y N Head and neck cancer/ Juno Therapeutics Malignant melanoma LEE-011 ribociclib Novartis/Otsuka CDK4 and CDK6 inhibitor Breast cancer PO Filed NDA 2Q2017 Y N Mantle cell lymphoma/ Indolent Non-Hodgkin lymphoma/Diffuse Large B- chimeric antigen receptor Cell Lymphoma 2Q2017 - KTE-C19 axicabtagene ciloleucel Kite IV Filed NDA Y Y (CAR) T cell therapy (DLBCL)/Chronic 4Q2017 lymphocytic leukemia (CLL)/ Small cell lymphocytic lymphoma (SLL) Huntington's disease/ vesicular monoamine Austedo deutetrabenazine Auspex Tourette's syndrome/Tardive PO Filed NDA 4/3/2017 Y Y transporter-2 (VMAT) inhibitor dyskinesia optum.com/optumrx 3 RxOutlook® 1st Quarter 2017 Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date Immune Response Remune HIV-1 vaccine vaccine HIV IM Filed BLA 4/5/2017 Y Y BioPharma Neurocrine vesicular monoamine Tardive dyskinesia/ Ingrezza valbenazine Biosciences/ PO Filed NDA 4/11/2017 N N transporter-2 (VMAT) inhibitor Tourette's syndrome Mitsubishi Tanabe Rheumatoid janus associated kinase 1/2 baricitinib baricitinib Eli Lilly/Incyte arthritis/Psoriasis/Diabetic PO Filed NDA 4/19/2017 Y N (JAK1/2) inhibitor nephropathy CCP-07 CCP-07 Vernalis/Tris Pharma undisclosed Cough and cold PO Filed NDA 4/20/2017 N N Neuronal ceroid BMN-190 cerliponase alfa BioMarin enzyme replacement Intracerebral Filed BLA 4/27/2017 Y Y lipofuscinosis type 2 (CLN2) anaplastic lymphoma kinase Non-small cell lung cancer AP-113 (AP-26113) brigatinib ARIAD PO Filed NDA 4/29/2017 Y Y (ALK) inhibitor (NSCLC) Isentress raltegravir Merck integrase inhibitor HIV PO Filed sNDA 5/27/2017 Y N Merkel cell carcinoma (MCC)/Gastric cancers/ programed death ligand-1 Non-small cell lung cancer avelumab avelumab Merck/Pfizer IV Filed BLA 5/29/2017 Y Y (PD-L1) inhibitor (NSCLC)/Ovarian cancer/ Urothelial cancer/Renal cell carcinoma Lupus nephritis/Psoriasis/ FastTrk/ Luveniq voclosporin ILJIN calcineurin inhibitor PO Mid-2017 Y Y Transplant rejection Breakthru Major depressive disorder Travivo gepirone ER GSK/Fabre-Kramer 5-HT-1A receptor agonist PO CRL Mid-2017 N N (MDD) CM-AT, CM 4612 CM-AT, CM 4612 Curemark protein absorption enhancer Autism PO InTrial Mid-2017 Y N Bausch and nitric oxide-donating Glaucoma/Ocular Vesneo latanoprostene bunod TOP CRL Mid-2017 N N Lomb/NicOx prostaglandin F2-alpha hypetension optum.com/optumrx 4 RxOutlook® 1st Quarter 2017 Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date analog human C1-esterase Berinert CSL Limited C1 inhibitor Angioedema SC Filed BLA Mid-2017 Y N inhibitor concentrate Amyotrophic lateral sclerosis Radicava edaravone Mitsubishi Tanabe free radical scavenger IV Filed NDA 6/16/2017 Y Y (ALS) Baxdela delafloxacin Melinta/Wakunaga fluoroquinolone Bacterial infections IV/PO Filed NDA 6/19/2017 Y N methylphenidate XR- Attention deficit hyperactivity Cotempla XR-ODT Neos Therapeutics CNS stimulant PO Filed NDA 6/20/2017 N N ODT disorder (ADHD) amphetamine/ Attention deficit hyperactivity SHP-465 Shire adrenergic receptor agonists PO Filed NDA 6/20/2017 N N dextroamphetamine salts disorder (ADHD) GF-00100100 ozenoxacin Medimetriks/Cipher quinolone (non-fluorinated) Bacterial infections TOP Filed NDA 6/22/2017 N N Deep vein thrombosis MK-4448 betrixaban Portola/Millennium factor Xa inhibitor (DVT)/Pulmonary embolism PO Filed NDA 6/24/2017 N N (PE) poly (ADP-ribose) polymerase Ovarian cancer/Breast niraparib niraparib Merck/TESARO PO Filed NDA 6/30/2017 Y N (PARP) inhibitor cancer TX-004HR, TX-12- estradiol TherapeuticsMD estrogen receptor agonist Vaginal atrophy Intravaginal Filed NDA 2H2017 N N 004HR long-acting muscarinic Chronic obstructive SUN-101 (EP-101) glycopyrrolate Sunovion INH Filed NDA 2H2017 N N receptor antagonist pulmonary diseaser (COPD) Fallopian tube Array MEK-162 binimetinib MEK inhibitor cancer/Melanoma/Ovarian PO Filed NDA 2H2017 Y N BioPharma/Novartis cancer/Peritoneal cancer protein kinase C-alpha (PKC- Acute myleoid leukemia PKC-412 midostaurin Novartis PO Filed NDA 2H2017 Y Y alpha) inhibitor (AML)/Mastocytosis Bristol Meyers sodium-dependent glucose SaxaDapa dapagliflozin/saxagliptin Diabetes PO CRL 2H2017 N N Squibb/AstraZeneca cotransporter 2 (SGLT-2) optum.com/optumrx 5 RxOutlook® 1st Quarter 2017 Estimated Route of Regulatory Specialty Orphan Drug name Generic name Company Drug class Therapeutic use release administration status drug drug date inhibitor/DPP-4 inhibitor Tarsa/Unigene Tbria salmon calcitonin osteoclast inhibitor Osteoporosis PO Filed NDA 2H2017 N N Laboratories Zalviso sufentanil, ARX-01 AcelRx opioid analgesic Pain SL CRL 2H2017 Y N Arcion FastTrk/ clonidine (ARC-4558) clonidine Therapetuics/BioDeli alpha-2-adrenoceptor agonist Diabetic neuropathy TOP 2H2017 N N Breakthru very Sciences antibody-drug conjugate (CD- 22 mAb linked to Acute myeloid leukemia FastTrk/ inotuzumab ozogamicin inotuzumab ozogamicin Pfizer /UCB IV 2H2017 Y Y calicheamicin, a cytotoxic (AML) Breakthru agent) etirinotecan pegol Breast cancer/Colorectal FastTrk/ etirinotecan pegol Nektar topoisomerase inhibitor IV 2H2017 Y Y (NKTR-102) cancer/Ovarian cancer Breakthru Cardiorentis/ vasodilator (synthetic human FastTrk/ ularitide acetate
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  • Pharmaceutical Appendix to the Harmonized Tariff Schedule

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    Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known.