Pharma major Dr. Reddy’s Laboratories has entered into a licensing agreement to obtain rights to New Jersey-based Slayback Pharma’s Brimonidine Tartrate Ophthalmic Solution 0.025%.
Slayback Pharma is the first to file an ANDA (abbreviated new drug application) for the private label equivalent for Lumify with the U.S. Food and Drug Administration (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, Dr. Reddy’s said in a release.
A trademark of Bausch & Lomb, 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.
“We are pleased to license this important OTC ophthalmic product for the U.S. market. It complements the company’s growing OTC product portfolio in eyecare category,” said Marc Kikuchi, CEO, North America Generics of Dr. Reddy’s.
CEO and founder of Slayback Ajay Singh, who was previously with Dr. Reddy’s as vice-president of strategy, portfolio and business development for the North American Generics Division, said, “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.”
Slayback is focused on complex generic and specialty pharmaceutical products has operations in the U.S., India and Europe, according to the company.
The value of total addressable market for the product in the U.S. is approximately $130 million for the 52 weeks period ending June 12, 2022, Dr. Reddy’s said citing IRI Data.
