Drug NameActive IngredientApplicantEstimated Sales (in Million USD)Chemical / BiologicalTherapeutic AreaFDA Approved IndicationApproval Date
BiktarvyBictegravir, Embitcitabine, Tenofovir AlafenamideGilead Sciences$5,269 ChemicalInfectious DiseasesTo treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen7-Feb-18
SymdekoTezacaftor; IvacaftorVertex Pharmaceuticals$2,750 ChemicalRespiratory DiseasesTo treat cystic fibrosis in patients age 12 years and older13-Feb-18
UltomirisRavulizumab-cwvzAlexion Pharmaceuticals$2,199 BiologicalRare Diseases / Blood DiseasesTo treat paroxysmal nocturnal hemoglobinuria (PNH)21-Dec-18
OrilissaElagolix SodiumAbbVie / Neurocrine Biosciences$2,000 ChemicalGynecologyFor the management of moderate to severe pain associated with endometriosis23-Jul-18
ErleadaApalutamideJanssen R&D$2,000 ChemicalOncology / UrologyTo treat a certain type of prostate cancer using novel clinical trial endpoint14-Feb-18
LutatheraLutetium Lu 177 DotatateAdvanced Accelerator Applications / Novartis Pharmaceuticals Corporation$2,000 ChemicalOncology / GastroenterologyTo treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).26-Jan-18
TakhzyroLanadelumab-flyoShire plc$1,800 BiologicalGenetic Diseases / ImmunologyTo treat types I and II hereditary angioedema23-Aug-18
OlumiantBaricitinibIncyte, Eli Lilly$1,800 ChemicalRheumatologyTo treat moderately to severely active rheumatoid arthritis31-May-18
XofluzaBaloxavir MarboxilShionogi & Co. Ltd, Roche AG$1,500 ChemicalFamily Medicine / OncologyFor the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. 24-Oct-18
LibtayoCemiplimab-rwlcRegeneron Pharmaceuticals$1,400 BiologicalDermatology / OncologyTo treat cutaneous squamous cell carcinoma (CSCC) 28-Sep-18
AndexXaCoagulation Factor Xa (Recombinant), InactivatedPortola Pharamceuticals$1,400 BiologicalHaematologyIndicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-theratening or uncontrolled bleeding.3-May-18
EpidiolexCannabidiolGW Pharmaceuticals, plc$1,300 ChemicalNeurology / PediatricsTo treat rare, severe forms of epilepsy25-Jun-18
OnpattroPatisiranAlnylam Pharmaceuticals$1,212 ChemicalGenetic Diseases / NeurologyTo treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients10-Aug-18
CrysvitaBurosumab-twzaUltragenyx Pharmaceutical / Kyowa Hakko Kirin$1,091 BiologicalGenetic Disease / MusculoskeletalTo treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets17-Apr-18
MektoviBinimetinibArray BioPharma Inc.$1,000 ChemicalOncology / HematologyTo treat unresectable or metastatic melanoma 27-Jun-18
LokelmaSodium Zirconium CyclosilicateAstraZeneca plc$1,000 ChemicalHematologyTo treat hyperkalemia18-May-18
AimovigErenumab-aooeAmgen / Novartis Pharmaceutical Corporation$1,000 BiologicalFamily Medicine / NeurologyFor the preventive treatment for migraine17-May-18
VitrakviLarotrectinibLoxo Oncology$860 ChemicalOncology To treat patients whose cancers have a specific genetic feature (biomarker)26-Nov-18
CopiktraDuvelisibVerastem Oncology$850 BiologicalOncologyTo treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma24-Sep-18
EmgalityGalcanezumab-gnlmEli Lilly$701 BiologicalNeurologyFor the preventive treatment of migraine in adults27-Sep-18
GalafoldMigalastatAmicus Therapeutics$612 ChemicalGenetic DiseasesTo treat treat adults with Fabry disease. 10-Aug-18
TalzennaTalazoparibPfizer Inc.$609 ChemicalObstetrics / GynecologyFor the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation. 16-Oct-18
DopteletAvatrombopagDova Pharmaceuticals$600 ChemicalHematologyTo treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure21-May-18
NuzyraOmadacyclineParatek Pharmaceuticals$500 ChemicalDermatology / Respiratory Diseases / Infectious DiseasesTo treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections3-Oct-18
AjovyFremanezumab-vfrmTeva Pharmaceutical Industries Ltd.$500 BiologicalFamily Medicine / NeurologyFor the preventive treatment of migraine in adults14-Sep-18
LumoxitiMoxetumomab Pasudotox-tdfkAstraZeneca plc$500 BiologicalOncology / HematologyTo treat hairy cell leukemia13-Sep-18
PifeltroDoravirineMerck & Co.$500 ChemicalInfectious DiseasesTo treat HIV-1 infection in adult patients30-Aug-18
BraftoviEncorafenibArray BioPharma Inc.$500 ChemicalOncology / HematologyTo treat unresectable or metastatic melanoma 27-Jun-18
ZemdriPlazomicinAchaogen, Inc.$500 ChemicalInfectious DiseasesTo treat adults with complicated urinary tract infections25-Jun-18
PalynziqPegvaliase-pqpzBioMarin$500 BiologicalHematology / OncologyTo treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)24-May-18
IlumyaTildrakizumab-asmnMerck & Co. / Sun Pharmaceutical Industries$500 BiologicalImmunology / DermatologyTo treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy20-Mar-18
TegsediInotersenAlnylam Pharmaceuticals / Akcea Therapeutics$497 ChemicalInternal Medicine / Genetic DiseaseTo treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults5-Oct-18
TrogarzoIbalizumab-uiykTheratechnologies / TaiMed Biologics$401 BiologicalInfectious DiseasesTo treat HIV patients who have limited treatment options6-Mar-18
FirdapseAmifampridineCatalyst Pharmaceuticals/ BioMarin$375 ChemicalMusculoskeletal / NeurologyTo treat Lambert-Eaton myasthenic syndrome (LEMS) in adults28-Nov-18
TavalisseFostamatinibRigel Pharmaceuticals$360 ChemicalHematologyTo treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)17-Apr-18
XeravaEravacyclineTetraphase Pharmaceuticals$340 ChemicalInfectious DiseasesTo treat complicated intra-abdominal infections in patients 18 years of age and older27-Aug-18
VizimproDacomitinibPfizer Inc.$336 BiologicalRespiratory Diseases / OncologyTo treat metastatic non-small-cell lung cancer27-Sep-18
GamifantEmapalumab-lzsgSwedish Orphan Biovitrum AB / Novimmune$330 BiologicalImmunologyTo treat primary hemophagocytic lymphohistiocytosis (HLH) 20-Nov-18
AnnoveraSegesterone Acetate And Ethinyl Estradiol Vaginal SystemTherapeuticsMD$300 ChemicalGynecologyNew vaginal ring used to prevent pregnancy for an entire year 10-Aug-18
TibsovoIvosidenibAgios Pharmaceuticals$300 ChemicalOncology / HematologyTo treat patients with relapsed or refractory acute myeloid leukemia 20-Jul-18
DaurismoGlasdegibPfizer Inc.$293 ChemicalOncology / HematologyTo treat newly-diagnosed acute myeloid leukemia (AML) in adult patients21-Nov-18
JiviAntihemophilic Factor (Recombinant), PegylatedBayer HealthCare LLC$273 BiologicalHematologyIndicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes29-Aug-18
LorbrenaLorlatinibPfizer Inc.$263 ChemicalPulmonary / Respiratory DiseasesTo treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer2-Nov-18
XospataGilteritinibAstellas Pharma$260 ChemicalOncology / HematologyTo treat patients who have relapsed or refractory acute myeloid leukemia (AML)28-Nov-18
AemcoloRifamycinCosmo Pharmaceuticals NV$250 ChemicalInfectious DiseasesTo treat travelers’ diarrhea16-Nov-18
YupelriRevefenacinTheravance Biopharma$250 ChemicalPulmonary / Respiratory DiseasesTo treat patients with chronic obstructive pulmonary disease (COPD)8-Nov-18
AsparlasCalaspargase Pegol-mknlShire plc$200 BiologicalOncology / HematologyTo treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years20-Dec-18
SeysaraSarecyclineParatek Pharmaceuticals, Actavis$200 ChemicalDermatologyTo treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older1-Oct-18
ElzonrisTagraxofusp-erzsStemline Therapeutics$130 BiologicalOncology / HematologyTo treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)21-Dec-18
PoteligeoMogamulizumab-kpkcKyowa Hakko Kirin$72 BiologicalOncology / HematologyTo treat two rare types of non-Hodgkin lymphoma8-Aug-18
MulpletaLusutrombopagShionogi & Co. Ltd$38 ChemicalHepatology / HematologyTo treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure31-Jul-18
MotegrityPrucaloprideShire plcNAChemicalGastrointestinal DisordersTo treat chronic idiopathic constipation14-Dec-18
RevcoviElapegademase-lvlrLeadiant BiosciencesNABiologicalImmunology / Genetic DiseaseTo treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)5-Oct-18
OxervateCenegermin-bkbjDompà farmaceutici S.p.ANABiologicalOphthalmologyTo treat neurotrophic keratitis22-Aug-18
DiacomitStiripentolBiocodex SASNAChemicalNeurology / NeonatologyTo treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam20-Aug-18
OmegavenFish Oil TriglyceridesFresenius KabiNAChemicalNeonatology / HepatologyAs a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis27-Jul-18
KrintafelTafenoquineGlaxosmithkline plc / Medicines for Malaria VentureNAChemicalInfectious DiseasesFor the radical cure (prevention of relapse) of Plasmodium vivax malaria20-Jul-18
TpoxxTecovirimatSiga TechnologiesNAChemicalInfectious DiseasesTo treat smallpox13-Jul-18
MoxidectinMoxidectinMedicines Development for Global HealthNAChemicalInfectious DiseasesTo treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older13-Jun-18
LucemyraLofexidine HydrochlorideUS WorldMeds / Salix PharmaceuticalsNAChemicalPharmacology / ToxicologyFor the non-opioid treatment for management of opioid withdrawal symptoms in adults16-May-18
AkynzeoFosnetupitant And PalonosetronHelsinn HealthcareNAChemicalOncology / Primary CareTo prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy19-Apr-18
PanzygaImmune Globulin Intravenous (Human)-ifasOctapharma Pharmazeutika Produktionsges.m.b.H.NABiologicalHematologyIndicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older and chronic immune thrombocytopenic purpura (ITP) in adults2-Aug-18