Mylan's Newly-Approved Alimta Generic Will Not be Sold Until 2022

Lung cancer

The U.S. Food and Drug Administration (FDA) gave tentative approval to Mylan’s pemetrexed, a generic version of Eli Lilly’s $2 billion lung cancer drug, Alimta. The late Thursday announcement gave the stock a nearly 4% bump to close at $19.90 per share.

Tentative approval typically means that the regulatory agency has gone ahead and greenlit the drug in question, but there’s usually a marketing delay involved due to patent concerns. Once the patents have expired or been overthrown in court, then the generic can be marketed. For Eli Lilly’s Alimta, the drug has exclusivity in the United States until 2022.

Alimta (pemetrexed) 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. Mylan isn’t the first to develop generics for Alimta. In 2017, New Jersey-based Eagle Pharma won tentative approval for Permfexy, its generic to Alimta.

Eli Lilly has been protective of Alimta, which generated more than $500 million in sales for the company during the second quarter this year. Earlier this month, the Indianapolis-based company successfully defended challenged to its patent from Dr. Reddy’s Laboratories and Pfizer. The two companies sought to launch alternative salt versions of pemetrexed and argued in court that their drugs did not infringe on Lilly’s patents for Alimta. The U.S. Court of Appeals ruled in favor of Eli Lilly saying that generic alternatives developed by those two companies would infringe on the Alimta patents. Also this month, the U.S. Court of Appeals ruled in favor of Eli Lilly regarding patentability of the vitamin regimen for Alimta.

“If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force,” Lilly announced following the verdict.

Companies like Mylan, Pfizer, Eagle Pharma and Dr. Reddy’s are hoping to take a bite out of the market share that Alimta currently maintains. According to Coherent Market Insights, the pemetrexed market was valued at $2.06 billion in 2017. The space was expected to grow at a slow pace, Coherent Market Insights said earlier this year.

As part of its own plan to protect Alimta, Eli Lilly has been seeking new indications for the chemotherapy drug. In January of this year, the FDA approved Alimta in combination with Merck’s Keytruda as a first-line treatment of metastatic nonsquamous non-small cell lung cancer.

While Mylan hasn’t challenged Eli Lilly’s patents in court, the company is currently in litigation against Novo Nordisk over a generic version of Victoza (liraglutide). Mylan is challenging Victoza in court in hopes of getting its drug to patients.

In July, Mylan and Pfizer’s off-patent medicines company, Upjohn, announced plans to merge to form a new pharmaceutical company. The company, which is projected to have revenues of up to $20 billion by 2020, will be renamed and rebranded when the merger is complete.

Back to news