• "What is the FDA regulatory status of semaglutide?"
• "Is there a generic for Humira?"
• "What ATC class does metformin belong to?"
• "Get adverse reactions from the ibuprofen drug label"
• "When does the patent for Eliquis expire?"
• "List all drugs in the ACE inhibitor class"
• "Find clinical trials for a biosimilar of adalimumab"

• Drug-drug interactions -> Use

  tooluniverse-drug-drug-interaction

• Pharmacogenomics / dosing by genotype -> Use

  tooluniverse-pharmacogenomics

• Drug mechanism of action / target binding -> Use

  tooluniverse-drug-mechanism-research

• Drug repurposing / new indications -> Use

  tooluniverse-drug-repurposing

Input (drug name / brand name / UNII)
  |
  v
Phase 1: Substance Identification  -- FDAGSRS_search_substances, FDAGSRS_get_substance
  |
  v
Phase 2: Drug Classification       -- RxClass_get_drug_classes, RxClass_find_classes
  |
  v
Phase 3: Approval & Generic Status -- FDA_OrangeBook_search_drug, FDA_OrangeBook_check_generic_availability
  |
  v
Phase 4: Patent & Exclusivity      -- FDA_OrangeBook_get_patent_info, FDA_OrangeBook_get_exclusivity
  |
  v
Phase 5: Label Parsing             -- DailyMed_parse_adverse_reactions, DailyMed_parse_dosing, etc.
  |
  v
Phase 6: Clinical Trials           -- search_clinical_trials
  |
  v
Phase 7: Pharmacovigilance         -- FAERS_count_reactions_by_drug_event (param: medicinalproduct)
  |
  v
Phase 8: Literature & Approval     -- PubMed_search_articles, OpenFDA_get_approval_history, RxNorm_get_drug_names

Supplementary tools (not in core phases but useful):

• OpenFDA_get_approval_history

  — full FDA submission/approval history (requires

  operation

  param)

• FAERS_count_reactions_by_drug_event

  — top adverse events by report count (param:

  medicinalproduct

  , ALL CAPS)

• RxNorm_get_drug_names

  — resolve drug to RXCUI and brand names

• drugbank_vocab_search

  — DrugBank ID, CAS, UNII lookup

• PubMed_search_articles

  — regulatory and clinical literature

query

substance_class

limit

{status, data: {substances: [{unii, name, substance_class, status, cross_references: [{type, value}]}]}}

• cross_references

  contains DrugBank IDs, WHO-ATC codes, CAS numbers, CFR citations.
• Use to get the official UNII identifier before calling

  FDAGSRS_get_substance

  .

unii

• Provides definitive list of all registered names (INN, USAN, brand, chemical).

unii

{status, data: {smiles, formula, inchikey, molfile, molecular_weight, stereochemistry, optical_activity}}

• Only works for chemical substances; returns error for biologics, mixtures, polymers.

undefined

drug_name

rxcui

rela_source

limit

{status, data: {classes: [{class_id, class_name, class_type, rela}]}}

• Returns ALL classification systems unless

  rela_source

  filters to one.

• class_type

  values: "ATC1-4", "EPC" (FDA Established Pharmacologic Class), "MoA", "VA", "MESH".
• Use to find a drug's ATC code, pharmacological class, mechanism of action label.

query

class_type

limit

• Use when you need to find a class ID before calling

  RxClass_get_class_members

  .

class_id

rela_source

ttys

limit

• ttys="IN"

  restricts to active ingredient-level entries (recommended).

undefined

brand_name

generic_name

application_number

limit

{status, data: {products: [{brand_name, generic_name, dosage_form, strength, te_code, application_number, approval_date}]}}

• Use brand name (UPPERCASE) or generic name to find NDA/ANDA numbers and approval info.

• te_code

  : Therapeutic Equivalence code (e.g., "AB" = therapeutically equivalent).

brand_name

generic_name

{status, data: {reference_listed_drug, generics_available: bool, generics_count, generic_products: [...]}}

• Primary tool for "is there a generic?" questions.

brand_name

application_number

application_number

undefined

application_number

brand_name

application_number

brand_name

{status, data: {exclusivities: [{exclusivity_code, exclusivity_date, description}]}}

• exclusivity_code

  values: "NCE" (New Chemical Entity, 5 years), "ODE" (Orphan Drug, 7 years), "PED" (Pediatric, 6 months), "NP" (New Product), "M" (new formulation).

condition

intervention

query_term

pageSize

max_results

limit

overall_status

status

{status, data: {studies: [{NCT ID, brief_title, brief_summary, overall_status, phase}], total_count}}

• Use

  intervention

  for drug name,

  condition

  for disease.
• Filter

  overall_status=["RECRUITING"]

  for active enrollment.

• total_count

  may be None even when results exist; check

  len(studies) > 0

  .

undefined

• Orange Book

  brand_name

  must be UPPERCASE (e.g.,

  "LIPITOR"

  )

• FDAGSRS_get_substance

  requires UNII, not drug name — call

  FDAGSRS_search_substances

  first

• FDAGSRS_get_structure

  only works for chemical substances, not biologics

• RxClass_get_class_members

  : pass

  ttys="IN"

  to restrict to active ingredients

• search_clinical_trials

  overall_status

  must be an array:

  ["RECRUITING"]

1. What is the current FDA approval status and pathway (NDA vs ANDA vs 505(b)(2))?
2. Are generic equivalents available, and what is their therapeutic equivalence rating?
3. When do key patents and exclusivities expire (or have they already)?
4. What drug class does this belong to (ATC, EPC, MoA), and what are peer drugs in the class?
5. What are the most clinically significant adverse reactions and contraindications from the label?