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

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.