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Mylan generic of lung cancer drug Alimta approved

Mylan NV’s generic version Eli Lilly and Co’s lung cancer drug, Alimta, has been given tentative approval by the FDA.

The US Food and Drug Administration (FDA) has granted tentative approval to Mylan NV for its generic version of Eli Lilly and Co’s lung cancer drug Alimta (pemetrexed).


A tentative approval generally signals that the FDA has signed off on the company’s marketing application, but that it cannot sell the medicine until the US patents have expired.

Alimta is a chemotherapy drug manufactured by Eli Lilly and has been approved by the FDA for the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC).

Earlier this month, a ruling confirmed that the Alimta (pemetrexed for injection) vitamin regimen patent would be an infringed by competitors that had stated their intent to market alternative salt forms of pemetrexed prior to the patent’s expiration in May 2022.

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US-exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force.

Alimta is Lilly’s third biggest-selling drug. The Indianapolis-based drug maker reported second-quarter sales of $577.8 million for the medicine, Reuters reported.

3 September 2019


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