Dr. Reddy's debuts generic Daraprim

Dr. Reddy’s is introducing pyrimethamine tablets in a dosage strength of 25 mg.

The product is the only generic of Vyera’s Daraprim (pyrimethamine) tablets.

“I am extremely proud of our teams at Dr. Reddy’s and Cerovene whose hard work and efforts, coupled with significant financial investments over the past seven years journey, have helped bring this important product to market,” Marc Kikuchi, CEO, Dr. Reddy’s North America Generics said. “Our team’s relentless pursuit of this difficult-to-procure reference drug and its active pharmaceutical ingredients — in addition to recent actions from the FDA — will benefit patients by providing a more affordable alternative to the brand.”

Dr. Reddy's product will be offered at a substantial discount compared with the current brand price, according to the company.

“The achievements of the Cerovene team to develop, file and manufacture Pyrimethamine tablets is a testament to our dedication and commitment to be able to provide this product to the patients who need it most. We are pleased to collaborate with Dr. Reddy’s as our commercial partner to make this important drug available to patients in the United States,” said Ray DiFalco, Cerovene co-founder and vice president of operations. “This approval represents our continued commitment to develop and provide patients with greater choices and lower-cost alternatives for prescription pharmaceuticals.”

Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide since synergism exists with this combination.

Dr. Reddy’s pyrimethamine tablets are available in bottle count sizes of 30 and 100.

The Daraprim (pyrimethamine) brand had a market value of approximately $10 million for the most recent 12 months ended January 2020, according to IQVIA.