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tooluniverse-drug-regulatory

Researches FDA and EMA drug approval status, generic availability, patents, and label data.

1.7k|254|Updated Mar 3, 2025
Search Tags:#regulatory#FDA#drug approval#orange book#dailymed#generic drugs#atc classification
One-click install
npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-drug-regulatory
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: tooluniverse-drug-regulatory
Source: https://github.com/mims-harvard/ToolUniverse/tree/main/plugins/tooluniverse/skills/tooluniverse-drug-regulatory
Command: npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-drug-regulatory

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

Determining a drug's regulatory status requires checking multiple fragmented sources — FDA substance registries, the Orange Book, RxClass classifications, and DailyMed labels — and status differs by jurisdiction. This Skill orchestrates those lookups into a structured workflow so you get accurate, current answers about approval pathways, generic availability, patent expiry, and exclusivity instead of guessing.

Core Features & Use Cases

  • Substance Identification & Classification: Resolve drug names to FDA UNII identifiers via FDAGSRS and retrieve ATC, EPC, and MoA classifications via RxClass.
  • Approval & Generic Status: Query the FDA Orange Book for NDA/ANDA numbers, therapeutic equivalence codes, generic availability, patent info, and exclusivity periods (NCE, ODE, PED).
  • Label Parsing & Pharmacovigilance: Extract adverse reactions, dosing, contraindications, and clinical pharmacology from DailyMed labels, plus FAERS adverse event counts and clinical trial searches.
  • Use Case: Ask whether a generic exists for Eliquis — the Skill checks the Orange Book for approved ANDAs, verifies exclusivity codes that may still block generics, and reports the therapeutic equivalence rating.

Quick Start

Ask the agent to check the FDA approval status, generic availability, and patent expiration for the drug Eliquis.

Frequently Asked Questions about tooluniverse-drug-regulatory

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I check if a generic version of a drug is available?▼

Use FDA_OrangeBook_check_generic_availability with the brand name in uppercase, such as LIPITOR. It returns whether generics exist, how many, and their therapeutic equivalence codes. Also check exclusivity, since NCE or ODE codes can block generics even after patent expiry.

How do I find a drug's ATC code or drug class?▼

Use RxClass_get_drug_classes with the drug name to retrieve ATC, EPC, MoA, and other classification systems. To list all drugs in a class, first call RxClass_find_classes with a keyword like "ACE inhibitor", then RxClass_get_class_members with ttys="IN".

Does FDA approval mean a drug is also approved by the EMA?▼

No. Regulatory status is jurisdiction-specific, so FDA approval does not imply EMA approval. Always specify the market when reporting status and check the relevant authority's data for the jurisdiction in question.

Why does FDAGSRS_get_substance fail with a drug name?▼

FDAGSRS_get_substance requires a 10-character UNII code, not a drug name. Call FDAGSRS_search_substances first with the drug name to retrieve the UNII, then pass it to FDAGSRS_get_substance for the full record.

What is the difference between an NDA, ANDA, and 505(b)(2) application?▼

A 505(b)(1) NDA is a full new drug application with complete sponsor data. A 505(b)(2) NDA relies partly on published literature or prior FDA findings and gets its own exclusivity. An ANDA is the generic pathway requiring only bioequivalence to the reference listed drug.

When should I not use this drug regulatory skill?▼

Use other skills for drug-drug interactions, pharmacogenomics dosing, mechanism-of-action or target binding research, and drug repurposing. This skill covers approval status, classification, patents, exclusivity, and label content only.

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