The FDA approved 93 first-time generics in the U.S. in 2021. This is compared to 72 first-time generics approved in 2020.
Most of these first-time generics were focused on health conditions like autoimmune disorders, heart disease, and diabetes.
During 2022, we may see first-time generics for medications like Vimpat and Januvia. The first generic for Restasis (cyclosporine eye drops) was one of the first notable approvals so far this year.
Many medications stocked on pharmacy shelves are classified as either brand-name or generic. Most medications filled in the U.S. are for the generic versions. Yet, due to patents on brand-name medications, lower-cost generic versions aren’t always available.
But once a patent expires, manufacturers can start making generics. The first one that the FDA approves is called a “first generic.” The FDA approves a number of first generics every year. In 2021, there were 93 first generics approved in the U.S.
Here, we’ll cover several notable first generics from 2021 and which medications might have first generics in 2022.
In 2020, the FDA approved 72 first-time generics. And 2021 saw even more, with 93 first-time generics. These medications are used to treat a number of health conditions, ranging from heart failure and autoimmune disorders to constipation. Below are a few notable approvals and if they’re available, what we know so far about costs.
Ivabradine is the generic name for Corlanor, a medication used to treat heart failure. It works by lowering your heart rate and has very few side effects. Brand-name Corlanor has an average retail price of roughly $600 for a 1-month supply. Generic ivabradine can help more people access this medication. But we don’t have cost information just yet.
Lubiprostone is the generic name for Amitiza, a medication used to treat certain kinds of constipation. It works by raising the amount of fluid in your intestines to help stools pass more easily.
The average retail price for brand-name Amitiza is over $460 for a 1 month supply. And while generic lubiprostone isn’t cheap, you can find it for as low as $158 using a GoodRx discount at certain pharmacies.
Linagliptin is the generic name for Tradjenta, a medication used to treat Type 2 diabetes. It works by stimulating your pancreas to make more insulin. Linagliptin is also available in combination with metformin as Jentadueto. Jentadueto also went generic this year.
Brand-name Tradjenta and Jentadueto have retail prices that are over $500 for a 1-month supply. The generic versions can help provide a more affordable treatment option. But we don’t have cost information yet.
Tofacitinib is the generic name for Xeljanz, a medication used to treat a number of autoimmune conditions. It works by blocking activity of proteins that cause inflammation. The FDA approved first generics for both the immediate-release and extended-release tablets.
Brand-name Xeljanz has an average retail price that’s over $8,000 for a 1-month supply. The extended-release version is over $8,500. The generic versions can make these medications more accessible. But we don’t have cost information just yet.
Pregabalin ER is the generic name for Lyrica CR, a medication used to treat nerve pain. Some people prefer it over the immediate-release version since you don’t need to take it as frequently. It’s thought to work by lowering activity in your nerves to relieve pain.
Brand-name Lyrica CR has retail prices over $520 for a 1-month supply. Generic pregabalin ER can still be expensive. But you can find it as low as $152 with a GoodRx discount at certain pharmacies.
Linaclotide is the generic name for Linzess, a medication used to treat certain kinds of constipation. It works by raising the amount of fluid in your intestines, which helps stools pass faster and more easily.
Brand-name Linzess has an average retail price that’s over $560 for a 1-month supply. Generic linaclotide could help make the medication more affordable. But we don’t have cost information just yet.
Varenicline is the generic name for Chantix, a medication used to help you quit smoking. However, brand-name Chantix was recalled this past year due to having certain chemicals that may raise the risk of cancer.
As such, the FDA allowed a generic Canadian version to be imported into the U.S. to help with access to the medication. Now, a generic version has been fully approved in the U.S.
Brand-name Chantix has an average retail price that’s over $580 for a 1-month supply. You can find generic varenicline for as low as $206 with a GoodRx discount at certain pharmacies.
Apremilast is the generic name for Otezla. It is used to treat plaque psoriasis, psoriatic psoriasis, and oral ulcers from Behçet’s disease. It works by lowering inflammation in your body.
Brand-name Otezla has a list price of almost $4,000. And it isn’t a medication you can typically fill at any pharmacy. Instead, it usually comes from a specialty pharmacy. This may also be the case with generic apremilast. But it’ll be a while before it’s available due to Otezla’s patent protection.
Many medications went generic for the first time in 2021. And 2022 will likely see several more. So far this year, this includes the first generic for Restasis (cyclosporine eye drops).
A few other notable brand-name medications that could have first generics in 2022 include:
Vimpat (lacosamide): a medication that can be used to prevent seizures
Januvia (sitagliptin): a blood sugar-lowering medication for Type 2 diabetes
Janumet XR (metformin/sitagliptin): a combination blood sugar-lowering medication for Type 2 diabetes
Last year, the FDA approved many first generics. These approvals can help provide people with lower-cost options for treating their medical condition.
There are several notable brand-name medications with patents expiring in 2022. It’s possible that we could see first generics approved over the course of the year. Check back with GoodRx for the latest first generic approvals.
Amgen Inc. (n.d.). How much does Otezla (apremilast) cost?
Food and Drug Administration. (2021). ANDA approval.
Food and Drug Administration. (2021). Generic drugs.
Food and Drug Administration. (2022). 2021 first generic drug approvals.
Food and Drug Administration. (2022). ANDA (generic) drug approvals - previous years.
Food and Drug Administration. (2022). First generic drug approvals.
Don’t miss out on savings!