Dr Reddy’s Laboratories has entered into a licensing agreement with New Jersey-based Slayback Pharma LLC to acquire rights in Slayback’s Brimonidine Tartrate Ophthalmic Solution, the private label equivalent of Lumify in the US.
Lumify is an over-the-counter (OTC) eyedrop that can be used to relieve redness of the eye due to minor irritations. The agreement also provides Dr Reddy’s exclusive rights to the product outside the US
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 percent in 2.5 ml and 7.5 ml fill volumes.
“We are pleased to license this important OTC ophthalmic product for the US market,” Marc Kikuchi, Chief Executive Officer, North America Generics, Dr Reddy’s said in a release.
“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 US is approximately $130 million for the 52-week period ending June 12, 2022, the release added.
Pataday Once Daily Relief and Pataday Twice Daily Relief are trademarks of Alcon.