September 2019 Report

September 2019 Report

NEW DRUG AND FIRST TIME GENERIC

New Drug Pipeline

Medication (Trade Name) Drug Class Therapeutic Use Status Update
Sumatriptan Nasal Spray
(Tosymra™)
Migraine Agent Migraine Headache Treatment Launch pending. Approved January 25, 2019.
Buprenorphine/Naloxone
(Cassipa®)
Opioid Agonist/Antagonist Opioid Misuse Disorder Launch pending. Approved September 7, 2018.
Benzhydrocodone HCl/
Acetaminophen
(Apadaz™)
Opioid Analgesic –
Immediate Release
Pain Anticipated second half of 2019. Approved February 23, 2018.
Buprenorphine Depot
Injection
(Brixadi™)
Opioid Agonist Treatment of
Opioid Addiction
Tentatively approved December 26, 2018.
Anticipated in November 2020 following
expiration of exclusivity period for Sublocade™.
Oxycodegol
(Loxicodegol)
Opioid Analgesic – Extended Release Pain FDA review pending.
Oxycodone HCl
(Rexista™)
Opioid Analgesic –
Extended Release
Pain FDA review pending after declining to approve in September 2017.
Naloxone Injection (Zimhi™) Opioid Antagonist Opioid Overdose FDA expected to review this higher dose of naloxone in a prefilled syringe October 2019.
Lasmiditan Serotonin 1F Receptor Agonist Migraine Headache Treatment FDA expected to review November 2019.
Ubrogepant CGRP Antagonist Migraine Headache Treatment FDA expected to review 4th quarter 2019.
Oxycodone HCl/
Naltrexone HCl
(SequestOx™)
Opioid Analgesic –
Immediate Release
Pain FDA declined to approve in July 2016. Expected
to review again in 2019.

Generic Pipeline

Medication (Trade Name) Drug Class Therapeutic Use Status Update
Hydrocodone Bitartrate
(Zohydro® ER)
Opioid Analgesic – Extended Release Pain Generic anticipated fourth quarter 2019.
Meloxicam
(Vivlodex®)
NSAID Pain Generic anticipated by end of 2019.
Doxepin
(Silenor®)
Tricyclic Antidepressant Sleep Disorders Generic anticipated January 1, 2020.
Naloxone HCl
(Narcan®) Nasal Spray
Opioid Antidote Opioid Overdose Launch pending. Generic approved April 19, 2019.
Emtricitabine/Trenofovir
(Truvada®)
Antiretroviral HIV Post-Exposure Prophylaxis Generic anticipated late 2020

Available in the Last 12 Months

Medication (Trade Name) Drug Class Therapeutic Use Status Update
Solriamfetol
(Sunosi™)
Stimulant Excessive Sleepiness July 2019
Meloxicam
(Qmiiz™ ODT)
NSAID Pain April 2019
Esketamine Nasal Spray
(Spravato®)
Antidepressant Treatment Resistant Depression March 2019
Sufentanil
(Dsuvia™)
Opioid Analgesic –
Immediate Release
Pain February 2019
Cannabidiol
(Epidiolex®)
Cannabinoid Seizures November 2018
Galcanezumab-gnlm
(Emgality™)
CGRP Antagonist Migraine Headache Prophylaxis October 2018

 

Newly Available Generics

Medication (Trade Name) Drug Class Therapeutic Use Status Update
Pregabalin
(Lyrica®)
Anticonvulsant Neuropathic Pain July 2019
Cyclobenzaprine HCl
(Amrix®)
Skeletal Muscle Relaxant Muscle Spasm March 2019
Fluticasone/Salmeterol
(Advair Diskus®)
Asthmatic Agent Asthma and COPD February 2019
Buprenorphine/Naloxone
(Suboxone®)
Opioid Agonist/Antagonist Opioid Misuse
Disorder
February 2019
Vardenafil
(Levitra®)
Phosphodiesterase
Inhibitor
Opioid-Induced
Erectile Dysfunction
October 2018