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DewDiligence

07/26/17 7:22 PM

#212683 RE: Bickema #212682

EGRX—...do you think Eli Lilly will file a lawsuit before or after the PDUFA date for [505b2] Pemetrexed?

Good question. LLY didn't sue upon notification of EGRX's 505b2 application, which would have afforded LLY an automatic 30-month stay on FDA approval of EGRX's product. So, I'm not sure how LLY intends to play this.

Since LLY's US CoM patent on Alimta has expired, the question is whether LLY intends to prosecute the '209 patent that covers dosing of Alimta in combination with vitamin B12 and folic acid (https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=021462&Appl_type=N ).