PROBLEM · SOLUTION · EVIDENCE · ACCESS
KINETISOL™ FOR GENERIC DRUG DEVELOPMENT
Turn loss of exclusivity into a formulation opportunity
As more amorphous solid dispersion products approach patent and exclusivity milestones, KinetiSol™ gives generic drug developers a solvent-free path to differentiated formulations, lower modeled manufacturing costs, and greater control over commercial supply.
THE OPPORTUNITY
Commercial ASDs represent an estimated $50 billion market based on peak annual sales. The opportunity continues to grow as poorly soluble and increasingly complex molecules enter the development pipeline.
- An estimated 80% of new chemical entities in the pipeline are poorly soluble
- Molecules increasingly present high melting points, heat sensitivity, and poor solubility
- The U.S. FDA approved 48 ASD products between 2012 and 2023
- 54% of these products were manufactured using spray drying
- High-value ASD products begin reaching patent and exclusivity milestones in 2026 and beyond
For generic developers, these products represent established markets with proven demand. They also present a manufacturing decision that can affect the product’s longterm commercial viability.
Sample set of ASD products coming off patent
THE MANUFACTURING PROBLEM
The ASD process selected today will influence capital investment, operating costs, supply chain complexity, and scale-up risk throughout the life of the product.
Spray drying can require:
- Large equipment and facility footprints
- Solvent purchasing, handling, and recycling
- Nitrogen generation
- VOC abatement or scrubber systems
- Additional development when production scales change
Changes between spray dryers can also affect particle properties and manufacturing performance, adding risk when scaling production up or down.
For a product entering a competitive generic market, this complexity can limit capacity options, increase operating costs, and make supply more difficult to control.
A SOLVENT-FREE ALTERNATIVE FOR GENERIC ASDs
KinetiSol™ is AustinPx’s next-generation, fusion-based ASD technology designed to improve the bioavailability of poorly soluble drugs. It uses frictional and shear energy to combine API with selected polymers and excipients, expanding formulation options for molecules that may be difficult to address with conventional ASD technologies.
Six advantages, one result
Featured Content: KinetiSol Compounder Video
ECONOMICS CASE STUDY
WHERE THE COST DIFFERENCE COMES FROM
Solvent-free is cheaper, not just simpler. In one commercial-scale ASD product modelled by AustinPx, over 85% of a spray-dryer feed is solvent; KinetiSol turns essentially more input into actual product.
Unit operations
Tablet ASD content: ~50% (spray drying) vs ~75% (KinetiSol).
Modelled result at commercial scale (U.S. dollars)
$20M
Annual cost of goods, spray drying
$12M
Annual cost of goods, KinetiSol
30-40%
Lower cost of goods for KinetiSol
PATENTS EXPIRE. OPPORTUNITIES OPEN. BUILD YOUR ADVANTAGE NOW WITH KINETISOL™.
Your formulation decisions today shape your manufacturing costs tomorrow. Meet with
AustinPx to explore a simpler, solvent-free path for your next generic product.