- In January 2025, the U.S. Food and Drug Administration (FDA) granted its first-ever marketing authorization for 20 ZYN nicotine pouch products under the Premarket Tobacco Product Application (PMTA) pathway. These pouches—small, synthetic fiber sachets containing nicotine—are placed between the gum and lip, offering a smokeless, spit-free alternative to traditional tobacco products.
- In June 2024, Dr. Reddy’s Laboratories Ltd. announced a landmark acquisition of Haleon plc’s global Nicotine Replacement Therapy (NRT) portfolio—excluding the U.S. The deal includes leading brands such as Nicotinell, Nicabate, Thrive, and Habitrol, spanning over 30 countries across Europe, Asia, and Latin America. This strategic move significantly strengthens Dr. Reddy’s footprint in the consumer healthcare and OTC wellness space, with the acquired portfolio covering lozenges, patches, gums, and pipeline products. Nicotinell alone ranks as the second-largest NRT brand globally holding top positions in 14 of the 17 largest markets
- In June 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted approval to Ayrton Saunders Limited for its next-generation, patented nicotine inhaler system—a major milestone in the nicotine replacement therapy (NRT) space. This innovative device is the first clinically approved inhaler to deliver nicotine directly via the lungs, enabling rapid craving relief without combustion, heat, or batteries. Designed like an asthma inhaler, it uses a breath-activated, refillable device with a pressurized nicotine solution, offering a clean taste, no visible exhalate, and discreet use in public spaces. The product is now cleared for over-the-counter sale and online advertising, setting the stage for commercial launches in the UK and beyond
- In April 2024, Kenvue’s nicotine gum and patch products became the first Nicotine Replacement Therapy (NRT) treatments to receive prequalification from the World Health Organization (WHO). This milestone is part of WHO’s initiative to improve global access to effective smoking cessation therapies, especially in low- and middle-income countries. The prequalification confirms the quality, safety, and efficacy of these products, enabling their broader deployment through UN agencies and public health programs. It also aligns with WHO’s new clinical guidelines that emphasize combining pharmacotherapy with behavioral support for better quit rates
- In December 2023, Lupin received U.S. FDA approval for its Varenicline Tablets (0.5 mg and 1 mg), a generic equivalent of Chantix®, developed by PF Prism C.V. This approval allows Lupin to market the product in the U.S. as a smoking cessation aid, expanding access to affordable Nicotine Replacement Therapy (NRT) options. The tablets will be manufactured at Lupin’s Pithampur facility in India, and the reference drug, Chantix®, had estimated annual U.S. sales of October 2023
