Tacrolimus (Prograf) 0.5 mg, 1mg and 5 mg capsules: Sandoz launched first generic in US

Generic player Sandoz has announced the introduction of Tacrolimus 0.5 mg, 1mg and 5 mg capsules, a generic equivalent of Prograf, in the US market. Tacrolimus is an immunosuppressive treatment used to help prevent rejection of a kidney or liver transplant.

Sandoz is the first and only company to launch generic Tacrolimus in the US, delivering on its strategy of being first-to-market with key products. With the introduction of Tacrolimus, Sandoz is expanding patient access to cost-saving transplant treatment options in the US.

Sandoz got final approval to market this product on Aug 10, 2009.

The product patent US4894366 expired on April 8, 2008. However, generics were not launched immediately after the expiry of product patent, as innovator filed citizen petition against the generic approval.

Innovator Astelles challenged USFDA’s bioequivalence protocol for the generic manufacturer. Further, innovator highlighted the importance of parameters for generic switch for physicians.

Importantly, USFDA denied citizen petition of innovator, which facilitated the generic approval process. As per USFDA, the current ANDA review process to establish quality safety and efficacy is adequate to establish interchangeability of innovator drug with generic version of Tacrolimus.

Earlier, innovator got approval to market this product on 1mg and 5 mg capsules on Apr 8, 1994 and 0.5 mg capsules on Aug 24, 1998