Lipocine was formed in 1997 to develop new branded drug products by improving currently marketed compounds by leveraging its lipid based technologies protected by 14 issued patents (20 patents pending).

Lipocine’s technologies include Lip’ral® for the optimal oral absorption of poorly water soluble drugs, Lip’ral® SSR for the controlled release of poorly water soluble drugs and Hydroance ® for the oral delivery of highly water soluble compounds, including macromolecules.

Lipocine develops its products through various value points and then seeks licensing partners for further development and commercialization. Most products utilize the FDA 505(b) (2) regulatory pathway (generally 18-24 months from project inception to PK only filing). Lipocine has licensed several products to corporate partners.

Currently Lipocine has 8 candidates in its product pipeline, indicated for diseases such as stoke, hormonal and respiratory disorders. Lipocine Technology can be applied to any poorly water soluble drug (~40% of all drugs), and poorly permeable drugs with absorption issues.

Lipocine can provide the following improvements for currently marketed drugs:

• Reduced dosing.

• Lower dose.

• Elimination of food restriction.

• Controlled release for poorly water soluble drugs.

• Reduced inter-patient variability.

• Reduction of side effects.

• Non invasive delivery options.

Lipocine is seeking potential partners with strong marketing, manufacturing and late stage clinical capabilities in place for each specific product available for license.
Products can be licensed to partners for an up-front licensing fee, milestones and royalty. Initial therapeutic categories of interest are hormone therapy, CNS/Pain, immunosupression, cardiovascular and respiratory.