An Expanding Product Portfolio
Impax’s ongoing strategy to invest in R&D to develop high-value, limited competition opportunities should continue to provide the potential for substantial growth in the future.
Our Products
We currently manufacture and market 102 generic pharmaceutical products, which represent dosage variations of 30 different pharmaceutical compounds through our Global Pharmaceuticals Division; another 16 of our generic pharmaceutical products representing dosage variations of four different pharmaceutical compounds are marketed by our alliance agreement partners.
We have 66 ANDAs approved by the FDA and currently market 43 of these through our Global Pharmaceuticals Division. A list of our currently marketed products can be found here.
Our Pipeline
Our current generic pipeline has never been more valuable than it is today with more first-to-file and first-to-market opportunities either pending or under development than ever before. We currently have 39 pending ANDAs with at least 7 ANDAs having first-to-file or first-to-market potential. The following lists our disclosed pending pipeline.
We are also working on an additional 79 products under development with many having the potential to be first-to-file or first-to-market opportunities. For 2011, our internal/external goal is to file at least 12 new applications with at least 3 of these being first-to-file or first-to-market opportunities.
Learn more about our generic pharmaceuticals division.
Our branded pipeline is focused on developing products targeting significant unmet needs in the CNS market. Within our branded division we are currently developing:
- A product for Parkinson’s disease (IPX066). Completed Naive Phase III Study (APEX-PD) and Advanced Phase III Study (ADVANCED-PD) and ASCEND-PD Phase III Study (IPX066 vs. carbidopa-levodopa plus entacapone). Targeting NDA filing in fourth quarter of 2011.
- A product for Restless Legs Syndrome (IPX159). Completed Phase IIa study. Filed Investigational New Drug (IND) Application in May 2011. Planning Phase IIb study in moderate to severe RLS in fourth quarter 2011 or first quarter 2012.
- A product for Spasticity in patients with Multiple Sclerosis (IPX056). Completed one Phase III study, with second Phase III study currently on hold, available for out-licensing.
