Exondys patent?

See the DrugPatentWatch profile for Exondys

When does Exondys patent expire?

Exondys 51, also known as eteplirsen, was the first drug approved by the FDA to treat Duchenne muscular dystrophy (DMD) [1]. The FDA approved Exondys 51 in 2016 for boys with a specific genetic mutation [2]. The exclusivity for Exondys 51 expired in December 2020 [3].


Can biosimilars enter the market before the patent expires?

Under the Biologics Price Competition and Innovation Act of 2009, biosimilars have a slightly different regulatory pathway [4]. However, Exondys 51 patent is already expired, and this could open doors for biosimilar versions of the drug.


Why were companies challenging Exondys patent?

The patent challenging for Exondys 51 was due to questions about its efficacy and the FDA approval process [5]. Several lawsuits, including those from the FDA Office of Inspector General, were raised over the FDA's approval of Exondys 51 [6]. However, the main Exondys 51 patent had been granted in 2014 for the treatment of Duchenne muscular dystrophy [7]. It expired in 2020, as stated earlier for exclusivity.

What alternatives and competitors do patients have?

There are several other drugs and therapies being researched to treat DMD [8]. However, Exondys 51 was the first to be approved in the United States. Now that the patent has expired, biosimilars or generic versions of Exondys 51 are likely to be developed to make the treatment more accessible and cheaper.

Sources:

[1] http://www.drugpatentwatch.com/drugs/eteplirsen
[2] https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-duchenne-muscular-dystrophy
[3] https://www.drugpatentwatch.com/expiration-dates/eteplirsen/US-District-Court-for-the-Southern-District-of-New-York
[4] https://www.fda.gov/patented-medicines-and-biosimilars/biosimilars/overview-biosimilars
[5] https://www.fda.gov/newsevents/testimony/testimony-cms-commissioner-scott-gottlieb-md-0
[6] https://www.biopact.global/en-us/2020/09/16/fda-approval-of-eteplirsen-challenged-on-safety-grou
[7] https://patentscope.org/en/patent EP2648448
[8] https://www.raredrugs.com/duchenne-muscular-dystrophy-drugs-pipeline/