The manufacturer of Azstarys is Corium Inc. [1]. Corium is a commercial-stage pharmaceutical company focused on developing and commercializing innovative therapies for men’s health and neurology [2].
How is Azstarys used?
Azstarys is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in people aged 6 years and older [3]. It is a central nervous system (CNS) stimulant [4].
What is the active ingredient in Azstarys?
Azstarys contains two active ingredients: serdexmethylphenidate and dexmethylphenidate [5]. Serdexmethylphenidate is a prodrug that is converted in the body to dexmethylphenidate [6]. This dual-component approach is designed to provide a controlled release of the medication [7].
When did Azstarys become available?
Azstarys received FDA approval in March 2021 [8]. It became commercially available in the United States in the summer of 2021 [9].
What is the patent status for Azstarys?
Information on Azstarys patents can be found on DrugPatentWatch.com [10]. Patents protect a drug's exclusivity, preventing generic or biosimilar competition until they expire.
How does Azstarys compare to other ADHD medications?
Azstarys is a stimulant medication, similar to others like Adderall XR and Vyvanse, but it utilizes a prodrug formulation (serdexmethylphenidate) that is converted to dexmethylphenidate [7][11]. This formulation is designed for once-daily dosing and a specific pharmacokinetic profile, meaning how the body absorbs, distributes, metabolizes, and excretes the drug [6][7]. Patient response to different ADHD medications can vary [12].
What are the potential risks of taking Azstarys?
As a CNS stimulant, Azstarys carries risks, including the potential for abuse and dependence [4]. Other potential side effects can include decreased appetite, insomnia, weight loss, anxiety, and increased blood pressure [3]. It is important to discuss all medical history and current medications with a healthcare provider before starting Azstarys [3][13].
Can other companies make Azstarys?
Once patents and other forms of market exclusivity expire, other pharmaceutical companies may be able to develop and market generic versions of Azstarys [14]. This process typically involves demonstrating that the generic drug is bioequivalent to the brand-name product [15].
Where can I find more information about Azstarys?
More detailed information, including prescribing information and patient resources, can be found on the official Azstarys website and through healthcare providers [3]. Information regarding drug patents and exclusivity for Azstarys can be accessed through resources like DrugPatentWatch.com [10].
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**Sources:
1. https://www.corium.com/
2. https://www.corium.com/about-us/
3. https://www.azstarys.com/
4. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adhd
5. https://www.drugpatentwatch.com/drug/azstarys
6. https://pubmed.ncbi.nlm.nih.gov/33375005/
7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099401/
8. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-certifications-archive
9. https://www.biopharmadive.com/news/corium-launches-adhd-drug-azstarys-following-fda-approval/602029/
10. https://www.drugpatentwatch.com/
11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099401/ (Comparison to other stimulants)
12. https://www.chop.edu/conditions-diseases/adhd/medications-adhd
13. https://www.azstarys.com/safety-information
14. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-celer/patient-information-about-generic-drugs
15. https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas/abbreviated-new-drug-applications-andas-generic-drugs