Product Development

Pipeline Opportunities

Noven’s Product Development capabilities and expertise extend from product formulation to product approval and beyond. Our capabilities include in-house product formulation, development, clinical testing, and regulatory and medical affairs. In its history, Noven has received FDA approval for nine products, and currently has applications for two developmental products pending.

Noven is also working collaboratively with its parent company, Hisamitsu, to develop new prescription transdermal systems, and potentially new transdermal technologies that could extend the number of compounds that can be delivered through the skin, bringing the benefits of patch therapy to patients around the world.

Noven is developing an amphetamine transdermal system (ATS) for ADHD. If approved, ATS could complement DAYTRANA® and offer physicians and caregivers a new option in the management of ADHD.

The following table summarizes the status of products approved and/or under development by Noven. Developmental products are identified in yellow.

noven-gradientsPre-ClinicalPhase IPhase IIPhase IIISubmissionANDA FiledNDA Filing Targeted for Q1/2021Phase II CompleteHP-1010ATSHP-5000