Mylan looks set to be able to launch its generic rival to Eli Lilly’s Alimta (pemetrexed) once patents have expired, after the US Food and Drug Administration (FDA) marked its abbreviated new drug application (ANDA) as being tentatively approved.
Tentative approval is provided to applications that meet application criteria while the reference product is still under patent.
During a recent court challenge to Alimta, in which Lilly won the case, the company stated that it holds patents on the product until May 2022 and would retain US exclusivity, if these were upheld, until this date.
The case saw rivals, in the form of Pfizer and Dr Reddy’s, attempt to launch alternative salt forms of pemetrexed into the US market prior to patent expiration on Alimta.
Retaining patent protection on Alimta until that date would be important to the company, with the product currently being its third highest selling product, as of second-quarter results.
Alimta is a chemotherapy treatment that is currently approved for the treatment of malignant mesothelioma and locally advanced or metastatic non-squamous non-small cell lung cancer.
For Mylan, the tentative approval, once Alimta comes off-patent, will add another string to the bow of the joint off-patent branded and generic medicines business that will be formed between Pfizer and itself.
Pfizer will add its generics business to the overall Mylan business to form a new company that is projected to generate revenues of $20bn (€18.2bn) in 2020. The company will be 57% owned by Pfizer shareholders, with Mylan shareholders taking the remaining shares.
The merger agreement arrived after Mylan posted a fall in total revenues for 2019 in its second-quarter results, after restructuring and remediation at its Morgantown, US, facility dented its financials during the first quarter.