Generic dextroamphetamine manufacturers?

What manufacturers produce generic versions of dextroamphetamine?

Several companies are approved to manufacture generic forms of dextroamphetamine, a central nervous system stimulant commonly used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy [1]. According to the FDA's Orange Book, a list of approved drugs and manufacturers, several companies are currently authorized to produce generic versions of dextroamphetamine [1].

Who are the main generic dextroamphetamine manufacturers?

Some of the notable manufacturers of generic dextroamphetamine include:

- Actavis (now part of Teva Pharmaceuticals)
- Amneal Pharmaceuticals
- Aurobindo Pharma
- Lannett Company
- Mylan
- Teva Pharmaceuticals
- West-Ward Pharmaceuticals

These companies, and potentially others [2], have obtained approval from the FDA to manufacture their versions of the drug [3].

How many generic versions of dextroamphetamine are available?

According to DrugPatentWatch.com, at least 20 different generic versions of dextroamphetamine have been approved by the FDA since 2010 [4].

Do generic versions of dextroamphetamine differ from the brand-name version?

Generic versions of dextroamphetamine must meet the same standards and requirements as the brand-name version. The FDA ensures that generic versions are chemically equivalent or "bioequivalent" to the brand-name version and are produced using the same manufacturing process [5]. As a result, most people who switch to a generic version of dextroamphetamine will not experience significant differences in efficacy or side effects [6].

Patent and exclusivity timeline

The original patent for dextroamphetamine expired on May 18, 2011. Following this, generic versions of the drug have become increasingly available, both from the mentioned companies and more. This increased competition has led to lower prices and better access to the medication for patients [7].

Sources:

[1] FDA (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. [Accessed 2023-02-15]

[2] DrugPatentWatch.com. (2023). Dextroamphetamine. [Accessed 2023-02-15]

[3] FDA (2020). FDA Approves Generic Versions of Attention Deficit Hyperactivity Disorder (ADHD) Medicine. [Accessed 2023-02-15]

[4] DrugPatentWatch.com. (2023). Dextroamphetamine. [Accessed 2023-02-15]

[5] FDA (2020). Generic Drugs: Frequently Asked Questions. [Accessed 2023-02-15]

[6] American Academy of Pediatrics (2020). Use of Stimulant Medications for ADHD. Pediatrics. [Accessed 2023-02-15]

[7] Kaiser Family Foundation. (2020). The Cost of Prescription Medications in the U.S. [Accessed 2023-02-15]