PRINCETON, N.J. — North American generics is Dr. Reddy’s largest market — in fiscal 2021, it contributed nearly $1 billion, representing a growth of 9% over the previous year and around 46% of the company’s gross generics sales; and 37% of overall sales. The introduction of new SKUs has helped to accelerate that growth.

In August 2020, Dr. Reddy’s launched ciprofloxacin dexamethasone otic suspension, a therapeutic equivalent generic version of Ciprodex, used in treatment of acute otitis. It also introduced O-T-C diclofenac sodium topical gel, the store brand version of Voltaren, which is used in the treatment of arthritic pain. The company also rolled out the generic version of sapropterin dihydrochloride tablets, used in treatment of blood phenylalanine levels.

“We are pleased to launch this first-to-market generic product, illustrating our continued commitment to bring affordable generic medicines to market for patients,” noted Marc Kikuchi, chief executive officer of North America generics at Dr. Reddy’s Laboratories. “At the same time, this product demonstrates that we are actively expanding the depth of our portfolio with our first otic suspension dosage form.”

The company is also refreshing its packaging and taking other steps to keep up with consumer desires. Last year, Dr. Reddy’s announced the relaunch of over-the-counter naproxen sodium tablets USP, 220 mg, the store-brand equivalent of Aleve, in the U.S. market, as approved by the Food and Drug Administration.

“The relaunch of Dr. Reddy’s naproxen sodium tablets, 220 mg (O-T-C), is an important addition to our pain/analgesics portfolio of O-T-C products,” Kikuchi said at the time. “This launch represents our continued endeavor to leverage our strong capabilities and vertically integrated supply chain on key APIs like naproxen to ensure a consistent and reliable supply of finished products for our customers and patients.”

Similarly, after Voltaren Arthritis Pain went O-T-C in the U.S. and Dr. Reddy’s introduced diclofenac sodium topical gel, 1%, the company brought the product to such retailers as Walgreens, CVS Pharmacy, Target Corp., Sam’s Club and Walmart. “To further enhance the appeal, we introduced a BOGO (buy one get one free),” according to Kikuchi.

More recently, the company announced the final approval of its Abbreviated New Drug Application for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg and 25 mg strengths, a therapeutic equivalent generic version of Revlimid (lenalidomide) capsules, from the Food and Drug Administration. The approval meant that the company became eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg.

“We are pleased with the agency’s approval of lenalidomide capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity,” Kikuchi noted. “We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”

The company is also steering toward a deeper move into complex formulations — primarily injectables and oral solid dosage forms — as well as O-T-C brands in the medium term and 505(b)(2) generics, drug device combinations and biosimilars.