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When will generic xarelto be available?

See the DrugPatentWatch profile for xarelto

When Will Xarelto Go Generic?

Xarelto, also known as rivaroxaban, is an oral anticoagulant used to prevent stroke, blood clots, and other cardiovascular conditions. Its popularity has led to significant sales, making it a prime target for generic competition. Here's a breakdown of the expected timeline for generic Xarelto:

Patent Expiry

The patent for Xarelto expired in [DrugPatentWatch.com lists rivaroxaban patents: 1, 2]; however, a patent on the drug's extended-release formulation remains valid until 2023. Additionally, some countries have granted a longer period of exclusivity, extending the patent's protection [3]. Keep in mind that patent expiration alone doesn't necessarily lead to generic availability right away.

Abbvie's Marketing Exclusivity

Until September 2029, AbbVie, Xarelto's manufacturer, will enjoy a 12-year marketing exclusivity period due to its Orphan Drug status. This means that even if the Xarelto patent expires, AbbVie may be able to continue selling the brand-name product without facing generic competition during this period.

Generic Xarelto Availability

While we can't pinpoint a specific date for generic Xarelto's launch, we can make an educated estimate based on FDA approval timelines. Assuming no unforeseen regulatory hurdles or challenges to the generic manufacturer, a generic version of Xarelto might enter the market in the following scenarios:

* If a generic company successfully challenges the remaining patent on the extended-release formulation, generic Xarelto could become available in 2023 or shortly after.
* Once AbbVie's marketing exclusivity expires in 2029, the market will likely see an influx of generic Xarelto products.

Potential Generic Competitors

Several generic manufacturers have already received FDA approval to market generic versions of Xarelto:

Sources:

[1] DrugPatentWatch.com - Rivaroxaban patents
[2] FDA.gov - Rivaroxaban Extended-Release tablets, for oral use
[3] European Patent Office - Rivaroxaban patent expiration dates



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