Generics
Dr. Reddy's Laboratories to License Exclusive Rights in the First-to-File ANDA for the Private Label Version of Lumify in the US
29 July 2022 - - Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) (NSEIFSC: DRREDDY) 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 US, the company said.

Lumify is an over-the-counter 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 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% in 2.5 ml and 7.5 ml fill volumes.

The value of total addressable market for this product in the US is approximately USD 130m for the 52 weeks period ending June 12, 2022.

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, with a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

The company's major markets include USA, India, Russia and CIS countries, and Europe.

Slayback Pharma is a specialty pharmaceutical company focused on the development and commercialization of complex, high-value ANDAs and patent-protected NDAs that address meaningful unmet needs.

Slayback has 116 employees, including over 75 in R and D who are located in its office and R and D laboratory in Hyderabad, India.
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