May 2021 Report

May 2021 Report

New and First Time Generic Drug Report

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New Brand Drug Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Naloxone Nasal Spray (Kloxxado™) Opioid Antagonist Opioid Overdose Launch pending. Approved April 29, 2021.
Celecoxib Oral Liquid (Elyxyb™) NSAID Migraine Headache Treatment Launch pending. Approved May 5, 2020.
Benzhydrocodone HCl/
Acetaminophen
(Apadaz™)
Opioid Analgesic –
Immediate Release
Pain Launch pending. Approved February 23, 2018.
Buprenorphine Depot
Injection
(Brixadi™)
Opioid Agonist Treatment of
Opioid Addiction
FDA declined to review December 2020.
Celecoxib/Tramadol NSAID/Opioid Agonist Pain FDA review pending.
Oxycodone Aximris XR™ Opioid Analgesic –
Extended Release
Pain FDA review pending.
Ansofaxine Antidepressant Major Depressive
Disorder
FDA review pending.
Naloxone Injection (Zimhi™) Opioid Antagonist Opioid Overdose FDA review pending.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Dabigatran (Pradaxa®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis First patent set to expire December 2021.
Oxycodone HCl (Oxaydo®) Opioid Agonist Pain Generic exclusivity anticipated in 2022.
Apixaban (Eliquis®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis Generics approved December 23, 2019, but settlements expected to delay launch for at least a few years.
Naloxone HCl
(Narcan®) Nasal Spray
Opioid Antagonist Opioid Overdose Launch pending. Generic approved April 19, 2019.

Available in the Last 12 Months

Medication (Brand name) Drug Class Therapeutic Use Status Update
Oliceridine (Olinvyk™) Injection Opioid Agonist Pain November 2020
Tramadol Oral Solution (Qdolo™) Opioid Agonist Pain October 2020

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
Pregabalin Extended Release (Lyrica® CR) Anticonvulsant Neuropathic Pain April 2021
Hydrocodone Bitartrate (Hysingla™ ER) Opioid Agonist – Extended Release Pain March 2021
Topiramate ER Capsule (Qudexy® XR) Anticonvulsant Headache, Neuropathic Pain February 2021
Emtricitabine/Tenofovir
(Truvada®)
Antiretroviral HIV Post-Exposure
Prophylaxis
January 2021
Meloxicam (Vivlodex®) NSAID Pain December 2020

Discontinuations & Withdrawals

Medication (Brand name) Drug Class Therapeutic Use Status Update
Naloxone HCl (Evzio®) Opioid Antagonist Opioid Overdose The manufacturer made a business decision to discontinue in September 2020.

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