When Will Generic Pradaxa Be Available? 5 Things to Know About Generic Pradaxa

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The treatment landscape for blood thinners has evolved over the past several decades. There are now a variety of options on the market to choose from, with Pradaxa (dabigatran) being one of them. Pradaxa is an oral blood thinner that prevents and treats blood clots.

Pradaxa and other brand-name medications are innovative products for people who need them. But they sometimes come with a high out-of-pocket cost. The good news is that if you ask your pharmacist "When will generic Pradaxa be available?," they'll tell you it's already here.

Here, we'll walk through the top five things to know about generic Pradaxa, so you can decide if the lower-cost option is right for you.

1. Generic Pradaxa is already available

Generic Pradaxa capsules first launched in 2022, courtesy of Camber Pharmaceuticals (subsidiary of Hetero Labs) and Ascend Laboratories. Before this, Boehringer Ingelheim was the only company that manufactured dabigatran (as brand-name Pradaxa).

Since the first generics were launched, other companies have begun manufacturing their own versions. This includes Alembic Pharmaceuticals, Apotex, Novadoz Pharmaceuticals, and more.

Good to know:Ascend Laboratories recalled its generic Pradaxa capsules in 2023 because they contained a potentially cancer-causing chemical known as nitrosamine. This recall is still active, but all affected products expired in July 2024 or earlier. Your pharmacist can switch you to a different Pradaxa generic if your medication has been recalled.

2. Generic Pradaxa works as well as the name-brand version

It's normal to wonder whether a generic medication is as effective as the brand-name version. Rest assured, generic Pradaxa works just as well as the name-brand medication.

All generic medications are required to go through quality testing. Essentially, manufacturers must prove their generic medications work the same way and provide the same clinical effects as the brand-name counterparts.

Generic medications can have minor differences from the brand-name versions. For instance, they can contain different inactive ingredients or colorings. These differences don't impact how the medications work.

Reach out to your pharmacist if you have any questions about generic Pradaxa. Sometimes, pharmacies swap generics, so it's possible that your medication may look unfamiliar when you pick it up at some point. Your pharmacist can let you know which generic version they've filled.

3. Patents kept Pradaxa generics off the market for more than a decade

Brand-name Pradaxa was approved by the FDA in 2010. Multiple patents prevented generic competition during Pradaxa's first several years on the market.

Patents generally last 20 years from the date they're submitted. They're typically granted while a manufacturer is developing a medication - so, even before the medication is approved. After a patent is granted, only the name-brand medication is allowed to be on the market.

The first Pradaxa patent expired in June 2022. This allowed generic versions to start trickling into the U.S. market.

Pradaxa oral pellets for kids

In 2021, Pradaxa became the first oral blood thinner approved to treat and prevent blood clots in kids. This version of Pradaxa comes as oral pellets, not traditional capsules. The pellets can be sprinkled on certain soft foods or mixed with apple juice, making the medication easier to swallow.

Pradaxa oral pellets are currently only available as a brand-name product. Generic Pradaxa oral pellets likely won't be approved until sometime after March 2026. But the exact date hasn't been determined yet.

4. Both versions come as oral capsules

Generic and name-brand Pradaxa products for adults are available as oral capsules. The capsules are typically taken by mouth twice a day.

The name-brand version comes as 75 mg, 110 mg, and 150 mg capsules. Generic Pradaxa products come in these same doses, but Apotex is the only manufacturer that currently makes generic 110 mg capsules.

Pradaxa oral pellets are available in several doses, ranging from 20 mg to 150 mg.

Good to know: Make sure to store generic and brand-name Pradaxa capsules in their original manufacturer containers. This is because moisture can cause the capsules to break down, making them less effective. Once a bottle is opened, the capsules are good for 4 months. Most bottles contain 60 capsules of medication.

5. You may see additional savings as more Pradaxa generics launch

Just as car prices go down as new models come out, medication prices tend to drop as more versions come on the market. So as more Pradaxa generics launch in the coming years, it's expected that the cost of the medication should continue to go down.

Several manufacturers are on track to release their own versions of generic Pradaxa in the future. Breckenridge and Dr. Reddy's Laboratories are two examples of manufacturers that have received tentative approval for their Pradaxa generics. This means the FDA recognizes the products as being safe and effective, but restrictions related to ongoing patent disputes are currently preventing them from receiving full approval.

How to save on Pradaxa

There are ways to save on both brand-name and generic Pradaxa. For example, GoodRx may be able to help you save over 60% off the average retail price of the generic version.

At certain pharmacies, the price for generic Pradaxa (dabigatran) may be as low as $69.00 with a free GoodRx coupon. And brand-name Pradaxa's price may be as low as $198.71.

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