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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Off-Patent Drug Repositioning.

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Drug repositioning can be improved by prioritizing off-patent (OFP) drugs first, followed by off-market (OFM) and then on-patent (ONP) drugs. This strategy considers patent validity and FDA exclusivities for drug repurposing.

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Area of Science:

  • Pharmacology and Drug Discovery
  • Intellectual Property in Pharmaceuticals
  • Medicinal Chemistry

Background:

  • Drug repositioning leverages existing drugs for new therapeutic indications.
  • Patents and FDA exclusivities pose barriers to immediate drug repurposing.
  • Classifying drugs based on intellectual property status is crucial for strategic repurposing.

Purpose of the Study:

  • To categorize drugs into on-patent (ONP), off-patent (OFP), and off-market (OFM) sets.
  • To analyze the characteristics of these drug categories.
  • To propose a prioritized drug repositioning strategy based on intellectual property.

Main Methods:

  • Analysis of FDA Orange Book data.
  • Inclusion of organic molecules and peptides (100-1250 Da).
  • Classification based on current patent validity and FDA exclusivities.

Main Results:

  • Identified 237 ONP, 996 OFP, and 320 OFM drugs.
  • Discussed differences in molecular properties, chemical diversity, MoA targets, and therapeutic areas.
  • Predicted an increase in OFP drugs available for repositioning.

Conclusions:

  • Drug repositioning strategies should prioritize OFP drugs, then OFM, and finally ONP drugs.
  • Intellectual property landscape significantly influences drug repurposing potential.
  • A systematic approach to drug classification aids in efficient repositioning.