sam asked
Hello, I was wondering if there is a generic form of Deplin that can be used in place of the prescription drug, Deplin?
At a glance
- Since Deplin is classified as a 'medical food', it does not have any FDA-approved generics. However, the active ingredient in Deplin, L-Methylfolate, is available as a medical food product from multiple manufacturers.
Answer
Deplin contains the active ingredient 'L-Methylfolate'.
L-Methylfolate is available in brand name products (like Deplin) and in generic products at your pharmacy but when it comes to the substitution of the brand name (Deplin) to a generic form, there is no FDA-approved generic.
There is no approved generic for Deplin because it is not a prescription drug but rather, is classified as a medical food by the Food and Drug Administration. Medical foods are not considered drugs and they are not subject to the legal requirements that apply specifically to drugs. Therefore, no product classified as a medical food has FDA-approved generics.
As medical foods aren't too common and are distinct from both prescription and over the counter products in regard to their regulation, there is often confusion surrounding them. I discuss them in more detail below and why no medical food has FDA-approved generic equivalents.
What Is A Medical Food?
Deplin is classified as a medical food. A medical food is a product classification that falls somewhere in-between prescription and over-the-counter items. Even though in most cases, your doctor will write you a prescription for medical food, it is not a prescription drug. Per the FDA, a medical food is defined as the following:
"A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Since medical foods are not considered drugs, the FDA does not subject them to the regulatory requirements of prescription drugs.
However, unlike over-the-counter products, which by law cannot state they are intended to treat any specific medical conditions, medical foods can make this claim.
For example, Deplin is used and marketed for the treatment of depression, while another medical food, Vayarin, is used for the treatment of ADHD.
Even though medical foods do not require a prescription per the FDA, they are intended to be used only under the supervision of a doctor. Again, per the FDA:
References
- Elsevier ClinicalKey: L-Methylfolate Monograph (Accessed 2/24/19)
- Deplin Patient Information
- Frequently Asked Questions About Medical Foods Guidance for Industry. Food and Drug Administration
- A Primer on Generic Drugs and A Primer on Generic Drugs and Bioequivalence. Food and Drug Administration
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Food and Drug Administration
