The patch is designed to be more discreet than injections for people taking insulin one demand - for example at mealtimes - and according to J&J that translates to higher rates of compliance with therapy and a reduction in embarrassment and discomfort for patients.
The company's Calibra Medical subsidiary is now planning to launch the drug in "limited markets" outside the US later this year, with a launch in the following "shortly thereafter," said a company spokesperson.
The delay to the launch since the FDA approval in 2012 came about because J&J was streamlining and automating the production process for the patch, which was formerly known as Calibra Finesse, she said, but would not go into any further details about J&J's launch plans.
According to J&J's worldwide vice president of R&D and innovation for diabetes care, Adrian Chernoff, 57% of diabetes patients are missing injections for various reasons, and this is impairing their glucose control.
"One Touch Via is worn on the abdomen under clothing and delivers two units of insulin on demand per click," he said, describing the product as a 'game changer'. "Users can easily tailor the dose by choosing the number of times they click," he added.
The can be worn for up to three days - it is water-resistant and can be worn when bathing - and is completely mechanical with no need for a handheld controller, display or battery. It is designed so it can be used alongside diabetics' basal insulin injections.
Data presented at the American Diabetes Association (ADA) annual meeting in June showed that more than 50% of patients using the device reported improved compliance - missing fewer mealtime doses than they would have done using a syringe or pen over a 60-day period.
After 60 days of use, 86% of patients were extremely/ very satisfied with the patch, 79% said they were extremely or very likely to ask their doctor for a prescription and 74% indicated they were likely to it as a replacement (60%) or in addition to (14%) their current delivery device.
J&J is also carrying out a clinical outcomes study that will compare the ability of the patch to insulin pens in its ability to control blood glucose and on patient quality-of-life scores.
The pharma industry's efforts to develop alternatives to insulin injections have largely been disappointing. Various oral insulin products have started development but failed in the clinic, although some candidates are still in development. Meanwhile inhaled insulins have reached the market but have not been successful commercially.
Given the gap in the market for an alternative to injections, J&J thinks it is on to a winner with the new patch, with a potential patient population of hundreds of million people worldwide, according to Chernoff.
The company is also working on new variations of the device, including one which will connect with a smartphone or similar device and a unit with a larger capacity (currently 200 units).