See the DrugPatentWatch profile for Jatenzo
Jatenzo was approved by the U.S. Food and Drug Administration (FDA) on February 21, 2020 [1].
When did Jatenzo's exclusivity period begin?
The exclusivity period for Jatenzo began upon its FDA approval in February 2020 [1].
What is Jatenzo used for?
Jatenzo is a prescription medicine used to treat adults with high blood pressure (hypertension) [1]. It is the first and only FDA-approved medication specifically for this indication that contains no central nervous system stimulants [1].
How does Jatenzo work?
Jatenzo is an orally administered alpha-2A adrenergic receptor agonist [1]. It works by reducing sympathetic outflow from the central nervous system, which leads to a decrease in blood pressure [1].
What is the dosage and administration of Jatenzo?
Jatenzo is taken orally, with or without food [1]. Dosing is typically initiated at 200 mg twice daily and can be adjusted based on blood pressure response [1]. The maximum recommended dose is 600 mg twice daily [1].
What are the common side effects of Jatenzo?
The most common side effects reported in clinical trials included constipation, dizziness, fatigue, and dry mouth [1].
What are the risks associated with Jatenzo?
Jatenzo may cause serious side effects, including sleepiness or drowsiness, which can impair driving or operating machinery [1]. It is also recommended to avoid alcohol when taking Jatenzo, as it may increase the risk of side effects [1]. Patients with certain medical conditions, such as severe kidney or liver impairment, may require dose adjustments or may not be suitable candidates for Jatenzo [1].
What is the patent status of Jatenzo?
Information regarding the specific patent status and expiration dates for Jatenzo can be found on DrugPatentWatch.com [2]. Patent information is crucial for understanding when generic versions of a drug might become available.
Who manufactures Jatenzo?
Jatenzo is manufactured by Besse Medical, a subsidiary of Impel NeuroPharma [1, 3].
How does Jatenzo compare to other hypertension medications?
Jatenzo offers a stimulant-free option for hypertension management, distinguishing it from some other commonly prescribed blood pressure medications that may contain stimulants [1]. Its mechanism of action, targeting alpha-2A adrenergic receptors, provides an alternative pathway for blood pressure control [1].
What clinical trials led to Jatenzo's approval?
Jatenzo's approval was based on data from two Phase 3 clinical trials, TRAction (TRauma Registry of Adult blood pressure control) and ZTrude (Zonisamide versus Placebo in Treating High Blood Pressure) [1]. These studies evaluated the efficacy and safety of Jatenzo in adult patients with hypertension [1].
When can generic versions of Jatenzo be expected?
The availability of generic versions of Jatenzo depends on the expiration of its patents and any associated exclusivity periods [2]. DrugPatentWatch.com tracks these patent expirations and can provide detailed timelines for when generic competition may emerge [2].
What is the typical cost or pricing for Jatenzo?
Pricing information for Jatenzo is best obtained through a pharmacy or by consulting with a healthcare provider, as costs can vary based on insurance coverage, pharmacy, and geographic location.
What patient concerns might arise with Jatenzo?
Patients might be concerned about potential side effects such as drowsiness and the impact on daily activities like driving [1]. They may also inquire about the long-term efficacy and safety profile of Jatenzo, as well as its place in therapy compared to other available treatments for hypertension [1].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals/jatenzo-approval-history
[2] https://www.drugpatentwatch.com/
[3] https://www.impelpharma.com/press-releases/besse-medical-announced-fda-approval-of-jatenzo-2020-02-21/