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:
Does FDA require that medical foods be made available by written or oral prescription? "No. The requirement for a written or oral prescription in section 503(b) of the FD&C Act and its implementing regulations at 21 CFR 201.100 only applies to the dispensing of prescription drug products. The Orphan Drug Act provides that medical foods must be formulated to be consumed or administered enterally under the supervision of a physician, but there is no requirement for a prescription."
Since 'medical foods' are not prescription drugs, they don't have FDA-approved generics. The active ingredient in Deplin, L-methylfolate, is available as a medical food in its own right, but again, is not technically an FDA-approved generic.
Generic Drugs And Therapeutic Equivalence
Generic forms of FDA-approved drugs need to undergo bioequivalence testing to ensure they have the same (within a statistical margin) rate and extent of absorption of the brand name counterpart. Only when a generic drug passes this testing, can it be labeled as 'substitutable' and a 'therapeutic equivalent' to the brand name.
The FDA website has a resource available called the 'Orange Book', which lists FDA approved drugs with therapeutic equivalence.
As an example, let's take a look at the FDA-approved drug, Lipitor:
Lipitor is available generically as 'atorvastatin'.
The Orange Book lists all of the FDA approved atorvastatin products (from all the different manufacturers of the drug, which is why there are so many listings) with the TE (Therapeutic Equivalence) Code 'AB', meaning the FDA considers them being therapeutically equivalent to the brand name Lipitor.
Therapeutically equivalent drugs are legally substitutable for one another. So, if you have a prescription that is for Lipitor, and the doctor does not specify that you can only have the brand, your pharmacy will substitute atorvastatin for it.
Since Deplin is not a prescription drug, it doesn't technically have any therapeutic equivalents and has no 'Orange Book' listing. The 'Patient Information' leaflet for Deplin also states this:
Even though Deplin is not an Orange Book drug, and therefore has no generic equivalents, there are several L-Methylfolate (the active ingredient in Deplin) products that should be available at your pharmacy. Just remember, they aren't technically considered generic equivalents to Deplin, so theoretically, they could have slightly different absorption profiles.
Generic forms of Deplin are available as:
They are available in two strengths:
- 7.5 mg
- 15 mg
The 7.5 mg and 15 mg tablets are manufactured by two companies:
- Breckenridge Inc
- Virtus Pharmaceuticals
The tablet form of L-Methylfolate (medical food) is also available as the brand name Elfolate.
The capsule form of generic Deplin is manufactured by (Breckenridge Inc).
Answer SummarySince 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.
- 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