About Us

Lipocine Inc. was founded in 1997 by distinguished drug delivery professionals, Drs. William Higuchi (former Co-founder and Chairman of TheraTech, a drug delivery company) and Mahesh Patel (Pharmacia and Upjohn). The company has numerous issued patents and several pending patent applications in most major markets. The company is headquartered in Salt Lake City and has its labs and business offices in research park, a technology hub close to University of Utah.

Lipocine Inc has clinically validated proprietary platform technologies for solving challenging drug delivery problems. The company has developed a proprietary portfolio of products with superior market attributes for development and commercialization. These superior attributes can include reduced dosing, elimination of food effect and elimination or reduction of certain side effects associated with the currently marketed drug.

Business Focus

Lipocine Addresses Key Product Improvement Opportunities

Lipocine works primarily to improve therapeutic performance of established drugs. Lipocine introduces product improvements to current drugs enabling product life extension options, and branding opportunities. The Company's products have the added benefit of patent protection from issued and pending Lipocine platform and product specific patents. In most cases, unlike a full new drug application (NDA) Lipocine product approvals require only limited clinical assessment resulting in inexpensive and expedient development/registration via the 505(b)(2) regulatory option.

Technology Focus

Lipocine solutions are targeted to addresses key unmet delivery/therapeutic needs

Solubility and Permeability:

More than 40% of all drugs discovered have solubility or permeability challenges related to drug delivery. The sales of molecules with sub optimal (less than 50%) oral bioavailability and poor water solubility accounted for approximately $57 billion, or 17% of worldwide sales in the year 2000. Although oral ingestion is regarded as the safest, most convenient and the cost effective method of drug administration, many existing poorly water-soluble drugs either cannot or are sub-optimally delivered orally with conventional dosage forms.

Conversely, most poor permeable and highly water-soluble drugs with poor oral absorption potential have to be delivered invasively. A great need exists for conventional and biotechnology derived hydrophilic products (peptides, proteins, genetic material, vaccines, etc.) for a non-invasive, more patient friendly delivery.

Faster onset for insoluble drugs

Insoluble drugs are known to be slowly and poorly absorbed. Lipocine s lipid based nano-dispersion technologies enable faster and more effective absorption, a desirable, but challenging attribute for certain insoluble actives.

Less frequent dosing for insoluble drugs

For better compliance and superior therapeutics, long acting, once- a- day oral dosing is most preferred. Due to propensity of inefficient absorption of insolubles coupled with extended release, traditional controlled release technologies are unable to deliver therapeutically relevant levels of insoluble drugs to enable less frequent dosing regimen. Lipocine is a leader in meeting this unmet need with breakthrough technologies for insoluble drugs.