Strides receives acceptance from USFDA for two key ANDAs

The combined market for the two products is US$ 550 mn and it could be eligible for a potential 180-day exclusivity

Strides Pharma Science (Strides) recently announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, received ANDA ‘acceptable for filing’ correspondence from the USFDA for two key ANDAs that met the prioritisation factors as a potential First Generic with a 10-month GDUFA II review goal date. As per IQVIA MAT data, the US market for these products cumulatively is US$ 550 mn.

The USFDA also granted Strides’ request to designate the drug product under these ANDAs as a Competitive Generic Therapy (CGT). If Strides is the first approved applicant with such competitive generic therapies, these products could be eligible for a potential 180-day CGT exclusivity, which functions in a similar manner to the patent challenge exclusivity for ANDAs.

Approval of the CGT designated ANDAs will be contingent on certain conditions including continued USFDA approval status for the manufacturing plant, API supplier, and CRO. While the CGT designated ANDAs will be eligible for a 180-day CGT exclusivity as subsequent generic will not be approved to market for 180 days after launch, the exclusivity will not preclude the marketing of product that receives approval prior to Strides commercialising the product.

 --------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.