Mylan gets provisional FDA greenlight for generic version of Lilly’s blockbuster cancer drug Alimta

pharmafile | September 2, 2019 | News story | Sales and Marketing Alimta, Cancer, Eli Lilly, FDA, Mylan, pharma 

Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster therapy Alimta (permetrexed) for the treatment of non-squamous non-small cell lung cancer (NSCLC) and mesothelioma.

This tentative approval means that Mylan will be cleared to market its product in the US, but only once Lilly’s patent on the originator medicine expires in the country. This means that Mylan will need to wait until May 2022, when the patent on low-cost generic competition is due to run out.  

The drugmaker saw its shares rise by 3.9% on announcement of the news. Lilly has fought off challenges to its Alimta patent, emerging victorious in an infringement lawsuit with India’s Dr Reddy’s and US-based Hospira. Its base patents for the drug expired in Europe and Japan in 2015, and in the US in 2017.

Lilly’s third biggest drug in its portfolio, Alimta recently generated $1.07 billion for the company in the first half of this year.

Matt Fellows

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