Validive (clonidine MBT)

Validive was designated as an Orphan Medicinal Product for the prevention of severe oral mucositis induced by chemoradiotherapy in head and neck cancer patients in the European Union (EU), enabling optimization of the product's development plan in consultation with the European Medicines Agency (EMA), as well as strengthening its protection (market exclusivity).

Validive is covered by 32 issued patents and allowed patent applications and corresponding patents and applications in 32 jurisdictions, including the U.S., EU, Japan, and other Asian countries, and has Fast Track designation from the FDA. These patents are method of use patents that cover the use of Validive to prevent and/or treat inflammation and inflammatory pain of the mucosa, including cancer therapy-induced mucositis.

Camsirubicin (MNPR-201; formerly GPX-150)

Camsirubicin is covered by both composition of matter as well as manufacturing process patents. A novel chemical composition of an intermediate for this synthesis is also patented. In addition, we have a method of use patent covering the combination of camsirubicin with paclitaxel for the treatment of cancer. Our camsirubicin patent portfolio contains seven issued and allowed U.S. patents and one U.S. pending patent application that covers additional analogs of camsirubicin. We have corresponding patents and applications in 29 foreign jurisdictions, including the U.S., EU, Japan, and other Asian countries. We have obtained orphan drug status in the U.S. and EU for soft tissue sarcoma.

MNPR-101 (formerly huATN-658)

Monopar's patent portfolio for MNPR-101, as well as its epitope, consists of two issued U.S. composition of matter and their method of use patents, and allowed patent applications and corresponding (granted and pending) patents and patent applications in 22 foreign jurisdictions, including the European Union, Japan, and other Asian countries.