Strides Pharma Receives US FDA Approval for Generic Renvela Tablets

Strides Pharma Receives US FDA Approval for Generic Renvela Tablets

By, Admin 14 May 2024

Overview

Strides Pharma Science’s step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for sevelamer carbonate tablets, 800 mg, from the United States Food & Drug Administration (FDA). 

Sevelamer Carbonate & Genzyme

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela tablets, 800 mg, of Genzyme. Sevelamer carbonate is a phosphate binder, that helps prevent hypocalcaemia (low levels of calcium in the body) caused by elevated phosphorus.
 
Total Market Size

  • Sevelamer carbonate tablets, 800 mg has a market size of ~US$ 181 million as per IMS. 
  • This approval further strengthens the company's presence in the sevelamer portfolio, complementing the existing approval of sevelamer carbonate powder for oral suspension, which has a market size of US$ 23 million. 
  • The sevelamer tablets will be manufactured at the company’s facility in Puducherry.

ANDA Filings

  • The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 245+ ANDAs have been approved. 
  • The company has set a target to launch ~ 60 new products over three years in the US. 

Sevelamer Carbonate

  • Sevelamer carbonate is a medication used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease. 
  • When consumed after a meal, the medication binds to dietary phosphate and prevents its absorption thereby managing overall phosphate levels in the blood.

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