InnoPharma’s generic program is targeted on developing complex drug products that incorporate more than one of the below:
- Difficult to develop for technical and scientific reasons, including molecules with solubility, stability, characterization and synthesis complexities
- Niche area of use
- Complicated manufacturing
- Complicated bio-equivalency or clinical studies
InnoPharma currently has 21 generic products pending at the FDA – 1 of which is confirmed FTF.
- The submitted ANDAs cover >$5B in US brand market sales
- 7 PIV filings addressing > $2.9B in US brand market sales
- 4 filings with expedited reviews granted addressing >$500MM in US brand market sales
There are greater than 30 products in various stages of development
- Addressing >$7B in US brand market sales
- 20 PIV filings targeted
Specialty pharmaceuticals includes novel and innovative new formulation/products of existing drugs that are developed to address certain unmet market needs including those with challenging formulation/processing issues. The added value provided to patients, providers and payor include:
- access to safer to handle
- easier to use
- currently unavailable dosage forms
- compliance that will improve patient experience, all with more cost effectiveness than the existing products.
InnoPharma has a broad portfolio of specialty pharmaceutical products one of which is currently filed and many others under development.