When does tizanidine expire?

See the DrugPatentWatch profile for tizanidine

What date do the Tizanidine patents expire?

Tizanidine is a centrally acting α2δ ligand used to treat muscle spasticity of various causes. The patents for Tizanidine held by various companies, including Abbott Laboratories, and Sandoz are set to expire on different dates across the globe [2].

What do these expirations mean for generic versions of Tizanidine?

According to a DrugPatentWatch analysis [1], the patent expiry dates indicate that generic versions of Tizanidine will become available for sale after the last patent expires.

When was Tizanidine initially approved and did any company hold patents before the others?

Tizanidine was first approved by the FDA in October 1996 [3]. Abbott initially held the patents but the rights eventually changed, as a consequence of patent disputes and settlements, and Sandoz took part in manufacturing.

The patents for various drugs have different expiry dates in various countries. In terms of exclusivity, the USA has specific exclusivity laws that can impact how these patents affect generic drug makers. As a result, generic producers are likely to follow the first patent that expired in this case as it has set the path forward toward generic versions.

How does this relate to patient access?

The introduction of generic versions will lower prices to consumers and make this product generally more accessible.

Will there be biosimilars available?

Biosimilars cannot come onto the market until 12 years after FDA approval of the original biologic product.

To learn more, please visit DrugPatentWatch [4].

Sources:

[1] DrugPatentWatch.com
[2] DrugPatentWatch.com database
[3] FDA.gov
[4] DrugPatentWatch.com