Dr. Reddy’s Laboratories Ltd. on Friday announced that it has entered into a licensing agreement with Princeton, New Jersey-based Slayback Pharma LLC, to acquire rights in Slayback’s Brimonidine Tartrate Ophthalmic Solution 0.025 percent, 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. According to the company’s press statement, the agreement also provides Dr. Reddy’s exclusive rights to the product outside the U.S.
The company claims that 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. 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,” said Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s in a statement.
“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,” Ajay Singh, CEO and Founder of Slayback stated on Friday.
Meanwhile, the value of the total addressable market for this product in the U.S. is approximately $130 million for the 52 weeks period ending June 12, 2022.