Why do some drugs not have generics?

If you’re trying to save money on prescription drugs, chances are you already know that generic versions cost a lot less, up to 85% less on average according to the FDA. But not all brand name drugs have generic counterparts. Why is this? You might think the answer has to do with patents, and that’s mostly right, but there are other reasons a brand name drug might not have a generic version. Let’s go through the reasons and expound on them a bit:
Photo credit: Ano Lobb. @healthyrx / Foter / CC BY

1. The drug patent is still in place.

Of course this is the biggest reason prescription drugs don’t have a generic version available yet. Most drug patents are protected for 20 years, but patents are usually applied for before clinical trials start, so the actual patent time while the brand name drug is being marketed might only span 7-12 years before expiring.

2. A generic version hasn’t been approved by the FDA yet.

Even though generic drugs don’t have to go through the full clinical trials that the initial brand name drug went through, they still must be evaluated by the FDA. If studies indicate that the generic version isn’t bioequivalent (absorbed in the same way) to the brand name drug, then it won’t be approved yet and the manufacturer will have to do further development and testing.

3. Patent litigation, settlements, and other possibly shady practices cause a delay in a generic drug making it to the market.

Drug-makers stand to lose a lot of money on their brand name drug once a generic version hits the market, and while most big pharmaceutical companies aren’t as evil as some like to claim, there are certainly cases where a generic drug can be stalled for several years even after the brand name patent expired.

Patent litigation is one technique. The drug-maker who owned the patent can sue the manufacturer of a generic version on the grounds that it still infringes on their patent in some area (even after a patent expires, there are still rules in place that prevent generic drugs from looking too similar to their name brand counterpart). This often ends with the name brand company paying the generic manufacturer a sum as part of an agreement where they agrees to hold off bringing their much cheaper generic version to market for a set number of years.

How can you tell if your prescription drug has a generic available yet, or when one might be available in the future?

The FDA provides a couple handy sources to figure this out:

The first is [email protected]. You can search by the active ingredient in your prescription to see if a generic has been approved yet. Or, if you don’t know the active ingredient, you can search by the trademarked name which will list it.

The second is FDA’s Orange Book. You can search by active ingredient, proprietary name, or a few other options. Once you find the drug you’re looking for, you can view patent information including when it’s set to expire.

But whether your prescription drugs have a generic form available or not, there are still ways to save on your prescriptions. The WiseRX card is a free discount prescription card that’s accepted at over 60,000 pharmacies nationwide and can save you up to 85% on your prescriptions. Not sure how discount prescription cards work? Read our How it Works page to learn more.

Leave a Reply

Your email address will not be published. Required fields are marked *