Zydus Mounts Challenge To Novartis With Generic Nelarabine Injection
US Rival To Arranon Has Been Granted 180 Days Of CGT Exclusivity
Zydus Cadila’s single-dose nelarabine injection (250mg/50ml) will enjoy 180 days of competitive generic therapy market exclusivity following approval from the US FDA, as the first approved rival to Novartis’ Arranon brand.
You may also be interested in...
Zydus Cadila has failed to prove to a US court that a US patent expiring in October 2025 that shields AstraZeneca’s Farxiga (dapagliflozin) SGLT2 inhibitor is obvious, keeping the firm’s proposed ANDA product off of the market for now.
Teva has opted against litigating with Pfizer over its controversial Xeljanz XR JAK inhibitor, settling patent infringement proceedings over a US patent scheduled to expire in 2034. Zydus Cadila recently bagged 180 days of exclusivity for a strength of its ANDA product.
Zydus Cadila has partnered with an Italian manufacturer to launch a generic version of preservative free Lovenox. Days earlier, the Indian firm’s management had discussed its hopes and expectations for its fledgling US injectables business.