Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that it has entered into a licensing agreement with Princeton, New Jersey based Slayback Pharma LLC (“Slayback”), to acquire rights in Slayback’s Brimonidine Tartrate Ophthalmic Solution 0.025%, the private label equivalent of Lumify® in U.S. Lumify® is an over-the-counter (OTC) eyedrop that can be used to relieve redness of the eye due to minor eye irritations. The agreement also provides Dr. Reddy’s exclusive rights to the product outside the U.S.
Slayback Pharma is the first company to file an ANDA for the private label equivalent for Lumify® with the USFDA under Paragraph IV certification. The ANDA is currently under USFDA 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, North America Generics, Dr. Reddy’s. “This product complements Dr. Reddy’s growing OTC product portfolio in the eyecare category that includes the private label versions of Pataday® Once Daily Relief and Pataday® 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 Ajay Singh, CEO and Founder of Slayback.
The value of total addressable market for this product in the U.S. is approximately $130 million for the 52 weeks period ending June 12, 2022.*