We have been present in the North American region, which includes the US and Canada, since the mid-1990s. It is our largest business, with revenue in FY’22 reaching a historic milestone of $1 billion, and FY’25 closing at approximately $1.7 billion. Our portfolio spans over 230 products across the retail, institutional, and over-the-counter (OTC) segments.
Our pipeline includes several first-to-market drugs and complex products, including drug-device combinations, peptides, and long-acting injectables.
In September 2022, we launched Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID® (lenalidomide) Capsules, approved by the U.S. Food and Drug Administration (USFDA). With this volume-limited launch, we became eligible for first-to-market, 180-day generic drug exclusivity for Dr. Reddy’s Lenalidomide Capsules in the 2.5 mg and 20 mg strengths.
Our growth in North America in FY’24 was largely driven by increased volumes in the base business, including Lenalidomide, as well as revenue from new product launches during the year. With patients at the center of everything we do, in December 2023 we entered into an exclusive collaboration with Coya Therapeutics, Inc. for the development and commercialization of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS). Read more about this here.
We acquired MenoLabs®, a leading portfolio in women's health and dietary supplements. We collaborated with Mark Cuban Cost Plus Drug Company to improve access to essential medications for patients with Wilson disease. We launched 20 new products, including Treprostinil Injection and Regadenoson Injection in the U.S., as well as products acquired from Mayne Pharma. We also filed 17 new Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (USFDA).
For selected drugs in our portfolio, we offer patient support services. We also partner with specialty pharmacies to unlock the potential of our complex and injectable generics in the growing specialty drug segment. One of the most recent ones is patient support services for Dr. Reddy’s Sapropterin Dihydrochloride. The services include a patient hub, co-pay assistance, benefits/reimbursement liaison, and nutrition and nursing support.
In addition, we have launched our own digital marketplace for the institutional segment DrReddysDirect.com.
We currently serve patients in over 14 European countries with our portfolio of generic and biosimilar medicines and OTC products across various therapeutic categories.
As healthcare challenges rise globally, we remain committed to increasing access to affordable medicines and developing products to serve unmet needs. Our generic medications are identical to approved brand-name drugs but are often available at a fraction of the cost, providing essential savings to healthcare systems and patients.
While we continue accelerating access in Europe, we have expanded our reach for consumer healthcare products by launching the anti-hay fever medicine Histallay® as an OTC product, making it available to patients faster. Our bevacizumab biosimilar received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Another essential addition to our portfolio is the drug-free migraine management wearable, Nerivio®, currently available in Germany, Spain, and the UK.
In addition to Dr. Reddy’s Laboratories, we operate through our German subsidiaries betapharm and Nimbus Health GmbH (Nimbus Health). While betapharm is a trusted brand for generics and OTC medicines, Nimbus Health is a licensed pharmaceutical wholesaler focused on medical cannabis. Medical cannabis is increasingly used to address and treat unmet medical needs, particularly in pain management and central nervous system (CNS) disorders. As more European countries adopt the usage of medical cannabis, Nimbus Health will expand into additional geographies.
As part of the growth strategy for Europe, we will continue to explore organic and inorganic opportunities. The latest example is the signed definitive agreement with Haleon plc, a leading consumer healthcare company, for the purchase of shares of Northstar Switzerland SARL, a Haleon group company, to acquire Haleon’s global portfolio of consumer healthcare brands in the Nicotine Replacement Therapy (“NRT”) category outside of the United States. The portfolio to be acquired consists of Nicotinell, a global leader in the NRT category with an extensive footprint in over 30 countries spanning Europe, Asia including Japan, and Latin America, and local market-leading brand names of the product: Nicabate in Australia, Thrive in Canada, and Habitrol in New Zealand and Canada. The proposed acquisition will include all formats, such as lozenge, patch, gum, and pipeline products, in all applicable global markets outside of the United States.
