We have seven proprietary product candidates in various stages of development and registration. 

Regulatory Pathway

SUDA Pharmaceuticals Ltd’s pipeline comprises well-characterised, market-leading drugs, which the Company has reformulated using its proprietary oral spray drug delivery technology. These oral spray formulations potentially offer improved efficacy, safety, patient compliance, and patient convenience, compared to the existing marketed products.

The strategy of reformulating marketed drugs allows SUDA to take advantage of development and regulatory pathways, which are faster and less expensive than for new chemical entities. SUDA’s products can potentially be approved in the USA by the US Food and Drug Administration (FDA) under the 505(b)(2) regulation; and in other major territories under similar legislation.

The 505(b)(2) regulatory path is designed for products that are reformulations of existing drugs approved by the FDA. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for the previously approved drug (known as the reference drug), thereby reducing the number of clinical trials required for approval.

Another incentive is three to five years of market exclusivity for 505(b)(2) products, depending upon the extent of changes to the reference product and the type of clinical data included in the approved New Drug Application (NDA).