Who Owns Exelon?

Rivastigmine, the active compound marketed as Exelon, was developed by Sandoz Pharma Ltd. in Basel, Switzerland, as part of a research program targeting the cholinergic deficit hypothesis of Alzheimer's disease. The hypothesis, which gained scientific consensus during the 1970s and 1980s, proposed that the cognitive decline characteristic of Alzheimer's disease was partly attributable to the loss of cholinergic neurons in the basal forebrain, resulting in reduced levels of the neurotransmitter acetylcholine in the cerebral cortex and hippocampus. Researchers at Sandoz identified rivastigmine as a selective inhibitor of acetylcholinesterase and butyrylcholinesterase, the enzymes responsible for breaking down acetylcholine, thereby increasing the availability of the neurotransmitter at synaptic junctions.

The development of rivastigmine proceeded through the 1980s and into the early 1990s, a period that coincided with the 1996 merger of Ciba-Geigy and Sandoz to form Novartis AG. The newly formed Novartis inherited the rivastigmine development program and advanced it through Phase III clinical trials. The pivotal trials demonstrated statistically significant improvements in cognitive function and activities of daily living in patients with mild-to-moderate Alzheimer's disease compared to placebo, supporting the drug's regulatory submissions.

The U.S. Food and Drug Administration approved Exelon (rivastigmine) capsules on April 21, 1997, for the treatment of mild-to-moderate dementia associated with Alzheimer's disease. This approval made rivastigmine one of the first cholinesterase inhibitors to receive regulatory clearance in the United States, alongside donepezil (Aricept, approved 1996) and tacrine (Cognex, approved 1993 but later withdrawn due to hepatotoxicity concerns). The European Medicines Agency granted approval in the same period, enabling Novartis to launch Exelon across major global markets.

A significant advancement came in 2000 when Novartis received approval for Exelon oral solution, which improved dosing flexibility for patients who had difficulty swallowing capsules, a common challenge in the elderly Alzheimer's population. The drug's label was subsequently expanded in 2006 to include the treatment of dementia associated with Parkinson's disease, broadening the eligible patient population and reinforcing Exelon's position in the neurological dementia treatment category.

The most commercially significant formulation development was the Exelon Patch, a transdermal rivastigmine delivery system approved by the FDA in July 2007. The patch offered several clinical advantages over oral formulations: more consistent plasma drug concentrations, reduced gastrointestinal side effects that had been a limiting factor with oral rivastigmine, and simplified once-daily administration that improved patient adherence. Clinical trials demonstrated that the 9.5 mg/24h patch provided efficacy comparable to the highest recommended oral dose with significantly better gastrointestinal tolerability. In 2013, the FDA approved a higher-dose 13.3 mg/24h patch for patients with severe Alzheimer's disease, making Exelon Patch the first and only transdermal therapy approved across all stages of Alzheimer's disease.

Generic rivastigmine capsules and oral solution became available in the United States following patent expiry, with multiple manufacturers receiving FDA approval. Sandoz, Novartis's own generics division, also markets generic rivastigmine, effectively competing with the branded Exelon in the oral formulation segment. The Exelon Patch retained longer patent protection, and Novartis has focused its branded marketing efforts on the transdermal formulation, where clinical differentiation and brand recognition continue to support commercial performance despite the availability of generic rivastigmine patches from competing manufacturers.