Key takeaways:
- The FDA approved 72 new first-time generic drugs in 2020.
- Several important brand-name drugs that went generic in 2020 include Daraprim, Teclfidera, Finacea, Glucagon, Pradaxa, and Flovent HFA.
- During 2021, we may see generic approvals for Truvada, Bystolic, and Brilinta.
The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for evaluating and approving new drug products proposed by manufacturers. Each year, there are new generic products, as well as “first generics.” A first generic is the first approved generic version of a brand-name drug approved for use in the United States.
As drug prices continue to rise year after year, lower-cost generic options are essential in helping people afford their medications. And last year, several high-cost medications finally went generic. Although their prices may be higher at first, this opens the door for more competition across generic manufacturers in the future.
This article will review some of the more notable generic drug approvals from 2020.
What is the difference between brand-name drugs and generic drugs?
Today, 90% of all prescriptions dispensed in the U.S. are for generic medications. But how do generics stack up against their brand versions?
Generic drugs are modeled after their brand-name equivalent — they have the same active ingredients in the same strengths, and they treat the same conditions. Although they can differ in shape, color, or inactive ingredients, this does not change how they work in the body.
Brand-name drugs can become available as a generic after their patent and exclusivity expire. This means that other pharmaceutical manufacturers are able to make generic versions, which can reduce the cost of the medication.
While brand medications go through the full FDA approval process, generics still need to show the FDA that they’ll work the same way in your body. So rest assured, you can expect to get the same benefit from these lower-cost alternatives.Don’t miss out on savings!Get the best ways to save on your prescriptions delivered to your inbox. By signing up, I agree to GoodRx’s terms of service and privacy policy, and to receive marketing messages from GoodRx.
What were the most high-profile generic approvals of 2020?
The Office of Generic Drugs (OGD), which is a division under CDER, releases an annual report detailing generic drug approvals for the year. Their 2020 data highlights that they approved or tentatively approved 948 generic drug applications, which is slightly lower than the 1,014 applications approved in 2019. However, they needed to pivot last year and prioritize treatments to address the COVID-19 pandemic.
Because of this, the OGD used new tools and strategies to handle reviewing manufacturers’ approvals, especially those critical for use in COVID-19 treatment. This included approving over 660 supplement submissions and 50 original applications for treatments used in COVID-19.
But of the 948 approvals in 2020, the CDER also approved 72 first-time generic drugs. Next, we’ll review several that caught the public eye.
What is pyrimethamine, and what does it treat?
The brand name of pyrimethamine is Daraprim, and it is used for the treatment of toxoplasmosis. Toxoplasmosis is a disease caused by a parasite, but you may not even know that you have it. In fact, almost 40 million Americans carry the parasite and may not ever experience symptoms unless their immune systems are weakened.
The name Daraprim may sound familiar given that it’s made headlines. When Martin Shkreli’s company Turing Pharmaceuticals acquired the medication in 2015, the price went from $13.50 a tablet to $750 a tablet, which outraged many people. Now that a generic version of Daraprim has been approved, hopefully, it will be cheaper in the future.
What is dimethyl fumarate, and what does it treat?
The brand name of dimethyl fumarate delayed-release capsules is Tecfidera, and it is used for the treatment for relapsing-remitting forms of multiple sclerosis (MS). Relapsing-remitting MS is a form of the disease where you go through periods of your symptoms getting worse (relapsing) followed by periods of improvement (remitting).
Although three generics for another oral MS medication called Gilenya (fingolimod) were approved in 2019, they may not be available for a while. That makes dimethyl fumarate the first generic oral MS medication approved and available in the United States.
What is generic glucagon, and what does it treat?
Glucagon is an injection used to help you bring up your blood sugar levels when they get dangerously low, which happens most commonly if you are using insulin to treat diabetes. This can be an emergency if your levels are low enough to cause you to pass out.
In this case, you’ll need assistance, and a rescuer or caregiver can then inject glucagon to make your blood sugar return to normal.
Although glucagon has been around for over 20 years, it hasn’t had an approved generic until now.
What is azelaic acid, and what does it treat?
The brand name for azelaic acid foam is Finacea, and it is used to help you manage symptoms of mild to moderate rosacea. Rosacea is a skin condition that causes inflammation and pus-filled bumps on your face.
Generic azelaic acid was already available as a topical gel, but that form may cause some irritation to skin that’s affected by rosacea. The foam, on the other hand, may be less bothersome for some people. Now that it’s available as a generic, people will hopefully have additional lower-cost options to treat their rosacea.
Other notable 2020 generic drug approvals
There were many other brands with first generic drug approvals that caught attention, including the following:
- Proventil HFA (albuterol sulfate inhalation aerosol): an inhaler used for preventing or treating symptoms of asthma, chronic obstructive pulmonary disease (COPD), or other lung conditions
- Pradaxa (dabigatran etexilate capsules): an oral medication that helps lower the risk of stroke or blood clots if you have a certain type of irregular heartbeat, or if you’ve previously had a blood clot in your leg or lungs
- Symfi and Symfi Lo (efavirenz, lamivudine, and tenofovir disoproxil fumarate): a combination of three different medications used together to treat HIV-1
- Vascepa (icosapent ethyl capsules): a form of an omega-3 fatty acid that is used to help lower high triglyceride (fat) levels in your blood
How much will I save on average by choosing the generic version of medications?
Once a brand-name drug becomes generic, there can be multiple manufacturers making it, which increases competition. The end result can be lower-cost options for consumers. In fact, generic medications typically cost less than their brand counterparts — on average, about 85% less. And if you’re taking several different generic medications, those savings can add up.
Are generic versions of any other popular medications set to be approved in 2021?
There are many medications that may go generic in the near future based on proposals submitted to the FDA. But keep in mind that approval and availability timelines for these medications are subject to change.
Over the course of 2021, we may see generic approvals of several popular brand-name drugs. Here are a few to look out for:
- Truvada (emtricitabine/tenofovir) used for HIV-1 treatment
- Bystolic (nebivolol) used for high blood pressure
- Brilinta (ticagrelor) used to prevent blood clots
- Atripla (efavirenz/emtricitabine/tenofovir) used for HIV-1 treatment
- Amitiza (lubiprostone) used for constipation
- Suprep (sodium sulfate, potassium sulfate, and magnesium oral solution) used as a bowel prep for people going to have a colonoscopy
The bottom line
Last year, generic drug approvals were not severely impacted despite the pandemic, and the FDA approved several new generics that will help people with HIV-1, asthma, heart disease, and other infectious diseases. Looking ahead to 2021, we’ve got several other popular brand medications that may have generic versions approved as well.
Leave a Reply