Definitions and Clarifications

“AI-generated drugs”

A drug will be considered “AI-generated” for this market if:

• A significant part of the drug discovery or design process was carried out using AI/ML models, and

• This involvement is explicitly stated in published academic literature, official press releases, or FDA submission documents, and

• The AI component had causal influence on generating the final molecular structure (not just post-hoc optimization or analysis).

Examples of qualifying methods include, but are not limited to:

• Generative models (e.g., reinforcement learning, generative adversarial networks, diffusion models) that proposed novel compounds

• Structure-based deep learning models that designed candidate molecules

• Transformer-based language models trained on chemical sequences or reaction data that suggested novel drug scaffolds

• AI-driven de novo design algorithms

Non-qualifying cases:

• Drugs where AI was only used for target identification, preclinical testing, or biomarker discovery but not the molecular structure

• Drugs discovered before 2010 and only optimized or re-evaluated using AI

• Drugs based on natural molecules or preexisting chemical libraries where AI played no generative role

“Approved by the FDA”

A drug is considered approved if:

• It receives New Drug Application (NDA) or Biologics License Application (BLA) approval from the FDA Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) by December 31, 2030 (11:59 PM ET)

Both small molecules and biologics are included. Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations count as long as they result in formal approval.

Excluded:

• Emergency Use Authorizations (EUAs)

• Investigational New Drugs (INDs)

• Devices or diagnostics (even if AI-designed)

“Distinct drugs”

Two drugs are considered distinct if they have:

• Different active ingredients or molecular structures

• Are approved separately by the FDA as unique NDAs/BLAs

Reformulations, repurposings, or new indications of an already-approved AI-designed drug do not count as additional approvals.