September 2021 Report

September 2021 Report

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New and First Time Generic Drug Report

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New Brand Drug Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
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 review pending.
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.
Nalmefene Injection Opioid Antagonist Opioid Overdose 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. Generic anticipated June 2022.
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
Naloxone Nasal Spray (Kloxxado™) Opioid Antagonist Opioid Overdose August 2021
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
Nebivolol (Bystolic®) Beta Blocker Beta Blocker September 2021
Ibuprofen/Famotidine (Duexis®) NSAID/H-2 Receptor Antagonist Pain/Inflammation August 2021
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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