Dr Reddy's Labs to acquire Slayback Pharma OTC ophthalmic product rights
Slayback Pharma is the first company to file an ANDA for the private label equivalent for Lumify with the USFDA under Paragraph IV certification.
Hyderabad: Pharma major, Dr. Reddy's Laboratories Ltd., has 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%, 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.
Read also: Dr Reddy's Labs unveils Bortezomib for Injection in US
Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.
Read also: Dr Reddy's Labs unveils generic version of Allegra in US
