On 8 Feb. 2020, USFDA approved Eagle’s Pemfexy™. In contrast to Alimta®, Pemfexy is the ready-to-dilute (RTD) formulation of Pemtrexed.
Pemfexy™ employs Pemetrexed in diacid form, while Alimta® employs Pemetrexed disodium salt. Another thing, Pemfexy™ requires being stored in refrigerated temperature (2°C-8°C (36°F-46°F)), while Alimta® vials are stored at Controlled Room Temperature (25°C (77°F)).
Eagle’s Launch plan:
Based on December 2019 press release, Eagle has reached a settlement agreement with Eli Lilly that provides an initial entry of Pemfexy™ into the market (equivalent to approximately a three week supply of Alimta® utilization) on February 1, 2022 and a subsequent uncapped entry on April 1, 2022 (Read here for more details).
It is worth to note that Alimta’s key vitamin regimen patent is set to expire on May 24, 2022 (with paediatric extension) and so far no generic applicant is successful in challenging vitamin regimen patent in the U.S.
Comparison between Pemfexy™ and Alimta is available below:
No comments:
Post a Comment