NOVEN PHARMACEUTICALS INC.

Company Snapshot

Founded: 1987

Entity Type: Private

Region: U.S.

Headquarter: Florida, U.S.

Key Geographics: U.S.

Corporate Address: 11960 SW 144th Street, Miami, Florida 33186 U.S. Tel: +1-305-253-5099 www.noven.com

Company Overview

Founded in 1987, Noven Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures and markets prescription pharmaceutical products. It is a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co. Inc. and serves as Hisamitsu's platform for U.S. prescription pharmaceuticals.

Noven offers transdermal drug delivery systems for women’s health and mental health. Women’s health products include CombiPatch, Minivelle and estradiol transdermal systems (authorized generic to Minivelle). Its mental health products include Secuado and Daytrana. Noven's commercialized products are marketed and sold through Noven Therapeutics LLC. Grove Pharmaceuticals is the generic division of Noven Therapeutics LLC.

Currently, Noven Pharmaceuticals has applications for two developmental products pending, amphetamine transdermal system (ATS) and HP-1010. Amphetamine transdermal system (ATS) is an investigational therapy for the treatment of attention deficit hyperactivity disorder (ADHD) for patients six years and older. In Feb. 2021, the company submitted a New Drug Application (NDA) with the U.S. FDA seeking approval to market ATS. HP-1010 is a transdermal patch for relief of pain associated with post-herpetic neuralgia. Noven Pharmaceuticals has already filed an abbreviated new drug application (ANDA) for HP-1010 with the U.S. FDA. The company is conducting clinical trials for a therapeutic drug candidate, HP-5000, a transdermal, pain relief and anti-inflammatory patch. HP-5000 has completed Phase II clinical study in the U.S.