For those anxious about generics, here is an option to know about: Authorized Generics
When someone visits the pharmacy for the first time, I always ask,
“Would you like to switch to a generic (off-patent) drug?”I ask.
Lowering out-of-pocket costs is appealing.
On the other hand, it is natural for some people to feel anxious, wondering, “Does it really work the same way?” or “Is the quality okay?”
In such cases,an option that is useful to know about as a generic close to the original brand-name drug is
the Authorized Generic (AG) option.
In this article,I will organize the differences between brand-name drugs, standard generics, and AGs.
First, what you need to grasp: The difference between brand-name drugs and generics
Drugs can be broadly divided into the following two types.
Brand-name drugs (original drugs): Drugs developed first
Generic drugs (off-patent drugs): Drugs with the “same active ingredients” made by another company after the patent period for the brand-name drug has ended
Brand-name drugs require a long time and significant costs for research, development, and clinical trials.
In return, the developing company is allowed to manufacture and sell them during the patent period.
On the other hand, generics have the same active ingredients and lower development costs, so it is generally considered that drug prices are easier to lower.
This is the main point: There are “AGs” among generics
Among generics, there is a classification calledAG (Authorized Generic).
What is an AG (Authorized Generic)?
Simply put, an AG is a
“generic drug that has received authorization from the brand-name drug manufacturer.”
As for the explanation, it is easy to understand if you organize it as follows.
A generic drug certified (authorized) by the brand-name drug manufacturer
The active ingredients, additives, and manufacturing methods (machinery and factories used for production) are the same as the brand-name drug
There are cases where the brand-name drug manufacturer manufactures the AG itself, but there are also cases where manufacturing is transferred to another manufacturer.
In other words,an AG is the same as a brand-name drug with only a different name.
However, it seems there are cases where “everything is not identical” (it may differ depending on the contract details and manufacturing system). Please check with your pharmacist to see if it is an entirely identical AG.
What happens to the price? AGs are the same price as or cheaper than regular generics
Since AGs are also generics, their drug prices are almost always lower than the original brand-name drugs. is.
Basically, they are the same price as regular generics, but depending on the timing of drug price revisions, there are cases where they become cheaper than regular generics (this varies by drug).
If there is almost no price difference, knowing whether an AG with characteristics similar to the original brand-name drug exists can be a helpful hint for choosing your medication.
The out-of-pocket payment rules (selected medical expenses) that began in October 2024
Here, I will touch upon recent changes to the system.
From October 2024 (Reiwa 6), when choosing a brand-name drug that has a generic equivalent (long-listed drug) based on the patient's preference,
a system has begun where a special fee is charged in addition to the standard co-payment (10-30%) has started.
According to the Ministry of Health, Labour and Welfare's guidance, this special fee is set to be
equivalent to one-fourth of the price difference between the brand-name drug and the generic drug
plus the consumption tax amount
as stated.
In other words, more than ever before,
there are situations where your drug costs will increase if you continue to choose brand-name drugs
.
In this climate, for those who think, “I prefer the brand-name drug, but the cost is increasing…” or “I am worried about generics…”,
the value of knowing about AGs as a powerful option
will increase.
Will out-of-pocket costs increase further? Raising the burden is currently under consideration
Furthermore, reports and analyses have emerged suggesting that, in preparation for the 2026 fiscal year medical fee revision, there is
consideration toward raising this special fee (patient burden) to at least one-half of the price difference.
This is not a final decision yet, but merely at the consideration stage. However, since there is a possibility that the system will change, it is reassuring to understand the mechanism early on.
Note: AGs are not necessarily available for all items
While AGs are a convenient option, there are points you should be aware of.
Not all brand-name drugs have an AG version
Even if an AG is on the market, it may not be immediately available depending on the pharmacy's adoption status and inventory
Therefore, in practical terms, the following phrase is the smoothest way to ask.
"Is there an AG (Authorized Generic) version of this medicine?"
If it is not in stock, it will be easier to discuss whether it can be ordered or to explore alternatives.
As a "realistic option" when you are unsure about generics
It is natural to feel uneasy about generics.
Especially if it is a medicine you take every day, it is only natural to want to "choose with confidence."
In such cases, AGs are
highly similar to the original brand-name drug (potentially almost identical to the original)
able to keep medication costs down as a generic
a potential option for those concerned about the out-of-pocket costs when requesting brand-name drugs
and are worth knowing about for these reasons.
The next time you pick up your medicine at the pharmacy,
please try asking, "Is there an AG version of this medicine?"
I hope this serves as a helpful tip that leads to a choice that is kind to both your body and your wallet.