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26 January 2015Americas

Eli Lilly moves to stop proposed Alimta generic

Eli Lilly has sued health care company Fresenius for allegedly infringing a patent covering its $2 billion-a-year lung cancer drug Alimta (pemetrexed).

It has also sought an injunction stopping Fresenius from making and selling its version of Alimta.

Lilly brought the case at the US District Court for the Southern District of Indiana, Indianapolis Division on Friday (January 23) in response to Fresenius’s amended filing of an Abbreviated New Drug Application (ANDA).

The ANDA, filed with the US Food and Drug Administration (FDA), sought approval to market a generic version of Lilly’s Alimta before US patent 7,772,209 expired.

Lilly’s ‘209 patent is titled “novel antifolate combination therapies” and covers a method of administrating pemetrexed disodium with folic acid and vitamin B12. It is due to expire in May 2022.

Lilly had already sued Fresenius (then APP Pharmaceuticals) in the same court, asserting the ‘209 patent. In the first case, the court rejected Fresenius’s challenge to the validity of certain claims in the ‘209 patent.

The latest action is directed to an amendment to Fresenius’s ANDA, which seeks FDA approval for the proposed generic in a larger dose.

Alimta is a chemotherapy agent used to treat various types of cancer. It can also be used in combination with cisplatin, another chemotherapy drug, to treat patients with pleural mesothelioma, or for the initial treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer.

Lilly has requested a judgment that Fresenius has infringed the ‘209 patent, that the effective date for any FDA approval of the proposed generic be after the patent expires, and for a preliminary and permanent injunction stopping Fresenius from making and selling its version of Alimta.

Alimta is one of Lilly’s best-selling medicines. In the year to September 30, 2014, it generated sales worth $2 billion worldwide.

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