Saturday, 14 April 2018

FDA approval@Sun Pharma receives tentative approval for Metformin HCL, Sitagliptin Phosphate

Sun Pharma has received tentative approval for Metformin HCL and Sitagliptin Phosphate, as per the USFDA website. Combination of Metformin HCL and Sitagliptin Phosphate are sold under the brand Janumet by Merck Sharp and Dohme Corp. Sun Pharma already has tentative approval for Sitagliptin Phosphate, which is sold under Januvia.

Janumet with Januvia clocked global sales of $6.1bn in 2017.

Metformin HCL and Sitagliptin Phosphate medicines help lower blood sugar in adults with type 2 diabetes. They have been under pricing pressure, but have been showing strong volume growth globally, as per Merck’s Q4 results .

The first patent on this drug is expected to expire in 2019, while several other patents will expire between 2022-2028. Janumet, as per Bloomberg data, clocked $2.3bn sales in 2017.

This is expected to be positive for Sun Pharma. It remains to be seen if this drug has been filed from Halol facility, in which case this will be more positive news for the comapny