Actavis Waits On Alimta Hybrid Following FDA Approval
Teva’s Actavis Obtains NDA Approval
FDA approval for a hybrid 505(b)(2) new drug application referencing Alimta has been awarded to Teva’s Actavis, with a key patent expiring in May 2022 proving a barrier to market entry. Teva was itself shot down over attempts to launch an ANDA product several years ago.
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In its half-year report, Stada has confirmed it continues to face the threat of damages from Eli Lilly, following its ‘at-risk’ launch in Germany of an alternative to the originator’s Alimta in July 2018.
The US Supreme Court has refused a certiorari petition to review a decision involving Dr Reddy’s and Pfizer over Eli Lilly’s Alimta that revolved around the doctrine of equivalents.
Hybrid 505(b)(2) rivals to Lilly’s Alimta from Dr Reddy’s and Pfizer do not literally infringe a key method-of-treatment patent protecting the pemetrexed brand until May 2022. But their alternative salts infringe under the doctrine of equivalents, the US Court of Appeals has confirmed.