Dr. Reddy’s Launches Prescription and Nonprescription Generics

The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.

Dr. Reddy’s Laboratories has made several moves in both the prescription and nonprescription space to add to its portfolio of branded and generic products.

The company has launched bortezomib for injection, the generic equivalent of Takeda’s Velcade (bortezomib) injection, which is approved to treat patients with multiple myeloma and mantle cell lymphoma. Dr. Reddy’s bortezomib is supplied in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use.

Dr. Reddy’s has also launched fesoterodine fumarate extended-release tablets, a therapeutic generic equivalent to Pfizer’s Toviaz (fesoterodine fumarate), which is used to treat the symptoms of overactive bladder, including leaks and strong sudden urges to go, in adults. Dr. Reddy’s fesoterodine fumarate extended-release tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.

Additionally, Dr. Reddy’s has acquired the portfolio of branded and generic injectable products from Deer Park, Illinois, based Eton Pharmaceuticals. The portfolio includes the hypotension therapies Biorphen (phenylephrine hydrocholoride) injection and Rezipres (ephedrine hydrochloride) injection NDAs with nine separate combinations of strengths and presentations and one first-to-file approved ANDA for cysteine hydrochloride for the United States. One strength each of Biorphen and Rezipres are currently commercially available.

“Long before the COVID-19 pandemic, there have been concerns about access to some critical care products for hospitals and health systems. This acquisition provides our North America organization with a foundational footprint to help address products that are not always readily available for patients,” Marc Kikuchi, chief executive officer, North America Generics, Dr. Reddy’s, said in a press release.

In nonprescription drug news, Dr. Reddy’s has entered into a licensing agreement with Princeton, New Jersey based Slayback Pharma to acquire rights in Slayback’s brimonidine tartrate ophthalmic solution 0.025%, the private label equivalent of Lumify in United States.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 United States.

Slayback Pharma is the first company to file an abbreviated NDA with the FDA for the private-label equivalent for Lumify. The ANDA is currently under review and covers brimonidine tartrate ophthalmic solution 0.025% in 2.5 ml and 7.5 ml fill volumes. This would add to the Dr. Reddy’s OTC product portfolio in the eyecare category that includes the private label versions of Pataday.

Additionally, Dr. Reddy’s has launched the first-to-market OTC fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg extended-release tablets, the store-brand equivalent of Allegra-D 24 Hour, an oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies. Dr. Reddy’s OTC fexofenadine/pseudoephedrine will be available in 5-count, 10-count, and 15-count pack sizes.