{
  "schema": "upg.factor.v1",
  "id": "ptce/meds/orange-book-te",
  "exam": [
    "PTCE"
  ],
  "domain": "Medications",
  "title": "Orange Book therapeutic equivalence (A vs B / AB)",
  "claim": "FDA\u2019s Orange Book assigns therapeutic equivalence (TE) codes to multisource drug products. First letter A means FDA considers the product therapeutically equivalent to other pharmaceutically equivalent products (including AB when bioequivalence issues were resolved with adequate evidence). First letter B means FDA does not currently consider it therapeutically equivalent. AB1/AB2-style three-character codes apply when multiple reference listed drugs exist under the same heading \u2014 products are TE only to others with the same three-character code.",
  "plain": "A-rated (incl. AB) = therapeutically equivalent under Orange Book. B-rated \u2260 TE. Matching AB1/AB2 matters when multiple RLDs exist. State substitution law still applies.",
  "confidence": 0.96,
  "citations": [
    {
      "authority": "FDA \u2014 Orange Book Preface (therapeutic equivalence codes)",
      "url": "https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface",
      "pin": "Orange Book Preface \u2014 A/B and AB codes",
      "retrieved_at": "2026-09-08",
      "quote": "\"A\" products are those for which there are no known or suspected bioequivalence problems or for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. ... Products meeting necessary bioequivalence requirements ... Multisource drug products ... generally will be coded AB if data and information are submitted demonstrating bioequivalence."
    }
  ],
  "updated_at": "2026-09-10",
  "token_cost_hint": 220,
  "integrity": "practice_only",
  "html": "/factors/ptce/meds/orange-book-te",
  "json": "/factors/ptce/meds/orange-book-te.json"
}