When will xarelto become generic?

When Does Exclusivity for Xarelto Expire?

Xarelto (rivaroxaban) is a medication used to prevent blood clots and stroke in patients with non-valvular atrial fibrillation. Its exclusivity period, also known as the patent term extension, affects when generic versions can enter the market.

According to the drug's patent data [1], Xarelto's patents started expiring in 2021, allowing generic companies to enter the market.

However, patent disputes and court decisions have influenced the timeline. A lawsuit by Janssen Pharmaceuticals (the manufacturer of Xarelto) against generic companies led to a stay on the launch of generic versions, pushing back the generic entry date [2].

In the United States, the FDA approved several generic versions of Xarelto in 2021, despite the ongoing patent litigation. As a result, multiple generic versions are available in the market [3].

For international markets, the exclusivity period for Xarelto varies based on country-specific patent laws. Some countries have approved generic versions, while others still have patent protection in place [4].

To navigate the changing landscape of Xarelto's market exclusivity, check with regulatory agencies and pharmaceutical companies for up-to-date information on generic availability.

Can Biosimilars Enter Before Patent Expiry?

Biosimilars are biologic products that are similar to existing biologics but with no patent protection. The development and launch of biosimilars might be impacted by patent disputes, as seen with Xarelto.

Xarelto's active ingredient, rivaroxaban, is a small molecule, not a biologic. Therefore, the development of a biosimilar is not possible [5].

Who Makes Generic Versions of Xarelto?

Multiple generic companies have received FDA approval for their versions of Xarelto. Some of these companies include Mylan (now Viatris), Sandoz, and Hetero. As the patent landscape evolves, more generic companies can enter the market.

References:

[1] DrugPatentWatch.com - Rivaroxaban patents
[2] Reuters - Janssen Pharmaceuticals sues generic company over Xarelto
[3] DrugPatentWatch.com - FDA approvals for generic Xarelto
[4] GlobalData - Expiration of rivaroxaban patents by country
[5] FDA - Biosimilar approval process