PRINCETON, N.J. – Dr. Reddy’s Laboratories has acquired U.S. rights to Slayback Pharma’s brimonidine tartrate ophthalmic solution 0.025%, the private label equivalent of Lumify. The-counter eye drop can be used to relieve redness due to minor eye irritations. The agreement also provides Dr. Reddy’s exclusive rights to the product outside the U.S.
Slayback is the first company to file an ANDA for the private label equivalent for Lumify with the FDA under Paragraph IV certification. The ANDA is currently under review and covers brimonidine tartrate ophthalmic solution 0.025% in 2.5 ml and 7.5 ml fill volumes.
“We are pleased to license this important OTC ophthalmic product for the U.S. market,” says Marc Kikuchi, chief executive officer of North America Generics for Dr. Reddy’s. “This product complements Dr. Reddy’s growing OTC product portfolio in the eye care category that includes the private label versions of Pataday Once Daily Relief and Twice Daily Relief.”
“Slayback is proud to develop this first-to-file ANDA for Lumify, a significant OTC product in the eye redness reliever category, that continues to highlight the R&D capability of the company,” said founder and CEO Ajay Singh.
The value of the total addressable market for the product in the U.S. was approximately $130 million for the year ended June 12, according to IRI.