Dr. Reddy's Laboratories said that it has entered into a licensing agreement with Slayback Pharma to obtain exclusive rights in the first-to-file ANDA for the private label version of Lumify in the U.S.
Slayback Pharma is a Princeton, New Jersey headquartered, specialty pharmaceutical company focused on the development and commercialization of complex, high-value ANDAs and patent-protected NDAs that address meaningful unmet needs. The company has built a differentiated, robust pipeline, while achieving consistent success in PIV-related patent litigations and earning nine exclusivities (seven sole first-to-files and two competitive generic therapies).
Lumify (Brimonidine Tartrate Ophthalmic Solution 0.025%) is the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness 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.
Marc Kikuchi, chief executive officer, North America Generics, Dr. Reddy's, said: 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.
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As per IRI data, the value of total addressable market for this product in the U.S. is approximately $130 million for the 52 weeks period ending 12 June 2022.
Dr Reddy's Laboratories is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.
The drug major's consolidated net profit surged 108% to Rs 1,187.6 crore on 6% rise in net sales to Rs 5,215.40 crore in Q1 FY23 over Q1 FY22.
The scrip fell 3.96% to end at Rs 4090.35 on the BSE yesterday.
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