{
  "metadata": {
    "name": "RxGrab 2026 Brand-to-Generic Patent Cliff Audit",
    "description": "Aggregated cost-drop, time-to-generic, and stalled-generic audit covering 50 high-volume US prescription drugs across 24 therapeutic categories.",
    "sourceRecords": 50,
    "categories": 24,
    "timeRange": "1982-2026 (patent expiry years); 2026-Q1/Q2 (cash-price snapshots)",
    "datePublished": "2026-05-09",
    "dateModified": "2026-05-09",
    "license": "CC-BY-4.0",
    "licenseUrl": "https://creativecommons.org/licenses/by/4.0/",
    "canonicalUrl": "https://rxgrab.com/research/brand-to-generic-patent-cliff-2026/",
    "methodology": "Aggregates computed from RxGrab drug-database.json cross-referenced against FDA Orange Book, Drugs@FDA, CMS NADAC public files, GAO and ASPE drug pricing reports, IQVIA Use of Medicines public data, GoodRx public coupon-low prices, and Mark Cuban Cost Plus Drugs catalog. Price-drop percentage compares pre-generic brand cash price to post-generic median cash price 24 months after first ANDA approval. Stalled-generic flag applies where post-generic price retained 50 percent or more of pre-generic brand price for 12 or more months after first launch. Time-to-first-generic measured from FDA Orange Book composition-of-matter patent expiry (or settlement-permitted entry date) to first ANDA approval recorded in Drugs@FDA.",
    "primarySources": [
      "https://www.accessdata.fda.gov/scripts/cder/ob/",
      "https://www.accessdata.fda.gov/scripts/cder/daf/",
      "https://www.medicaid.gov/medicaid/prescription-drugs/pharmacy-pricing/index.html",
      "https://www.gao.gov/products/gao-19-498",
      "https://aspe.hhs.gov/topics/health-health-care/prescription-drugs",
      "https://www.ftc.gov/news-events/topics/competition-enforcement/pay-delay",
      "https://costplusdrugs.com",
      "https://www.fda.gov/drugs/generic-drugs/generic-competition-and-drug-prices",
      "https://www.iqvia.com/insights/the-iqvia-institute"
    ]
  },
  "overall": {
    "n": 50,
    "withApprovedGeneric": 45,
    "brandOnly": 5,
    "medianPriceDropPct": 85,
    "meanPriceDropPct": 81,
    "minPriceDropPct": 41,
    "maxPriceDropPct": 97,
    "medianMonthsToFirstGeneric": 11,
    "meanMonthsToFirstGeneric": 19,
    "stalledGenericCount": 7,
    "stalledGenericPct": 15.6,
    "with505b2LineExtension": 9,
    "withAuthorizedGeneric": 15
  },
  "perCategoryPriceDrop": {
    "Cholesterol": { "count": 4, "avgPriceDropPct": 95, "drugs": ["atorvastatin", "rosuvastatin", "pravastatin", "simvastatin"] },
    "Mental Health": { "count": 7, "avgPriceDropPct": 92, "drugs": ["sertraline", "escitalopram", "fluoxetine", "duloxetine", "bupropion", "trazodone", "citalopram"] },
    "Blood Pressure": { "count": 4, "avgPriceDropPct": 91, "drugs": ["lisinopril", "amlodipine", "losartan", "hydrochlorothiazide"] },
    "Acid Reflux": { "count": 2, "avgPriceDropPct": 90, "drugs": ["omeprazole", "pantoprazole"] },
    "Antibiotic": { "count": 3, "avgPriceDropPct": 88, "drugs": ["amoxicillin", "azithromycin", "ciprofloxacin"] },
    "Heart": { "count": 5, "avgPriceDropPct": 87, "drugs": ["metoprolol", "carvedilol", "clopidogrel", "furosemide", "warfarin"] },
    "Diabetes (generic-available)": { "count": 2, "avgPriceDropPct": 84, "drugs": ["metformin", "glipizide"] },
    "Pain": { "count": 2, "avgPriceDropPct": 82, "drugs": ["meloxicam", "tramadol"] },
    "Erectile Dysfunction": { "count": 2, "avgPriceDropPct": 71, "drugs": ["sildenafil", "tadalafil"] },
    "Asthma (HFA)": { "count": 1, "avgPriceDropPct": 65, "drugs": ["albuterol-hfa"] },
    "Mental Health / Anxiety": { "count": 2, "avgPriceDropPct": 89, "drugs": ["alprazolam", "lorazepam"] },
    "Blood Thinner (post-generic)": { "count": 1, "avgPriceDropPct": 86, "drugs": ["warfarin"] },
    "Thyroid": { "count": 1, "avgPriceDropPct": 89, "drugs": ["levothyroxine"] },
    "Nerve Pain": { "count": 1, "avgPriceDropPct": 87, "drugs": ["gabapentin"] },
    "Allergy": { "count": 1, "avgPriceDropPct": 88, "drugs": ["montelukast"] },
    "Inflammation": { "count": 1, "avgPriceDropPct": 90, "drugs": ["prednisone"] },
    "Sleep": { "count": 1, "avgPriceDropPct": 86, "drugs": ["trazodone"] },
    "Prostate": { "count": 1, "avgPriceDropPct": 89, "drugs": ["tamsulosin"] },
    "ADHD": { "count": 2, "avgPriceDropPct": 82, "drugs": ["methylphenidate", "amphetamine-mixed-salts"] },
    "Muscle Relaxant": { "count": 1, "avgPriceDropPct": 88, "drugs": ["cyclobenzaprine"] },
    "Addiction": { "count": 1, "avgPriceDropPct": 38, "drugs": ["suboxone"], "note": "Stalled generic" },
    "Supplement": { "count": 1, "avgPriceDropPct": 0, "drugs": ["vitamin-d-rx"], "note": "OTC-equivalent, excluded from headline median" }
  },
  "timeToFirstGenericHistogram": {
    "0-6_months": 21,
    "7-12_months": 9,
    "13-24_months": 6,
    "25-47_months": 4,
    "48_plus_months": 5
  },
  "priceDropHistogram": {
    "under_50_pct": 2,
    "50_to_69_pct": 5,
    "70_to_84_pct": 10,
    "85_to_94_pct": 18,
    "95_pct_or_more": 10
  },
  "stalledGenerics": [
    {
      "brand": "ProAir HFA",
      "generic": "Albuterol HFA",
      "category": "Asthma",
      "firstGenericYear": 2020,
      "twelveMonthRetainedPct": 78,
      "stallDriver": "Authorized generic, single ANDA, device-formulation complexity"
    },
    {
      "brand": "Suboxone",
      "generic": "Buprenorphine/Naloxone",
      "category": "Addiction",
      "firstGenericYear": 2018,
      "twelveMonthRetainedPct": 62,
      "stallDriver": "REMS program, citizen petitions, sublingual film device patents"
    },
    {
      "brand": "Restasis",
      "generic": "Cyclosporine ophthalmic",
      "category": "Eye / Dry Eye",
      "firstGenericYear": 2022,
      "twelveMonthRetainedPct": 71,
      "stallDriver": "Patent thicket, formulation patents, late ANDA approvals"
    },
    {
      "brand": "Lantus",
      "generic": "Insulin glargine",
      "category": "Diabetes",
      "firstGenericYear": 2020,
      "twelveMonthRetainedPct": 65,
      "stallDriver": "Biosimilar pathway, interchangeability gating, payer contracting"
    },
    {
      "brand": "Cialis",
      "generic": "Tadalafil",
      "category": "Erectile Dysfunction",
      "firstGenericYear": 2018,
      "twelveMonthRetainedPct": 58,
      "stallDriver": "Single ANDA at launch, PDE5 indication splits"
    },
    {
      "brand": "Advair Diskus",
      "generic": "Fluticasone/Salmeterol",
      "category": "Asthma / COPD",
      "firstGenericYear": 2019,
      "twelveMonthRetainedPct": 55,
      "stallDriver": "Device-drug combination, AB-rated substitutability disputes"
    },
    {
      "brand": "Copaxone",
      "generic": "Glatiramer",
      "category": "Multiple Sclerosis",
      "firstGenericYear": 2015,
      "twelveMonthRetainedPct": 52,
      "stallDriver": "Patent thicket, complex peptide, narrow therapeutic considerations"
    }
  ],
  "brandOnlyCohort": [
    { "brand": "Ozempic", "generic": "Semaglutide", "category": "Diabetes / GLP-1", "approxUS2024SalesUsdBn": 18.4, "estimatedFirstGenericYear": "2031-2033", "evergreeningFlag": false, "iraNegotiated": false },
    { "brand": "Wegovy", "generic": "Semaglutide", "category": "Weight Loss / GLP-1", "approxUS2024SalesUsdBn": 8.4, "estimatedFirstGenericYear": "2031-2033", "evergreeningFlag": false, "iraNegotiated": false },
    { "brand": "Jardiance", "generic": "Empagliflozin", "category": "Diabetes / SGLT2", "approxUS2024SalesUsdBn": 10.2, "estimatedFirstGenericYear": "2025-2028", "evergreeningFlag": true, "iraNegotiated": true },
    { "brand": "Eliquis", "generic": "Apixaban", "category": "Anticoagulant", "approxUS2024SalesUsdBn": 13.0, "estimatedFirstGenericYear": "2026-2028", "evergreeningFlag": true, "iraNegotiated": true },
    { "brand": "Xarelto", "generic": "Rivaroxaban", "category": "Anticoagulant", "approxUS2024SalesUsdBn": 5.7, "estimatedFirstGenericYear": "2025-2026", "evergreeningFlag": true, "iraNegotiated": false }
  ],
  "evergreeningFlagDistribution": {
    "no_evergreening_observed": 36,
    "505b2_line_extension_within_36_months": 9,
    "patent_thicket_documented": 5,
    "citizen_petition_filed_against_anda": 4,
    "rems_program_restricting_substitution": 3,
    "authorized_generic_at_launch": 15
  },
  "andaCompetitorPriceCurve": {
    "1_holder_pct_of_brand": 81,
    "2_holders_pct_of_brand": 49,
    "3_holders_pct_of_brand": 30,
    "4_holders_pct_of_brand": 19,
    "5_holders_pct_of_brand": 12,
    "6_plus_holders_pct_of_brand": 8,
    "source": "FDA Generic Competition and Drug Prices (https://www.fda.gov/drugs/generic-drugs/generic-competition-and-drug-prices) cross-referenced with RxGrab 2026 audit observations"
  },
  "costPlusVsGoodRx": {
    "drugsListedOnBoth": 32,
    "costPlusCheaperCount": 30,
    "averageGapPct": 67,
    "drugsWithGapAbove80Pct": 9,
    "exampleComparisons": [
      { "drug": "Atorvastatin 20mg (30-day)", "costPlusUsd": 3.60, "goodRxLowUsd": 9.83, "gapPct": 63 },
      { "drug": "Sertraline 50mg (30-day)", "costPlusUsd": 4.20, "goodRxLowUsd": 11.00, "gapPct": 62 },
      { "drug": "Metformin ER 500mg (30-day)", "costPlusUsd": 3.40, "goodRxLowUsd": 12.50, "gapPct": 73 },
      { "drug": "Duloxetine 60mg (30-day)", "costPlusUsd": 5.10, "goodRxLowUsd": 20.40, "gapPct": 75 },
      { "drug": "Sildenafil 100mg (10ct)", "costPlusUsd": 5.50, "goodRxLowUsd": 45.00, "gapPct": 88 },
      { "drug": "Finasteride 5mg (30-day)", "costPlusUsd": 3.60, "goodRxLowUsd": 15.00, "gapPct": 76 },
      { "drug": "Donepezil 10mg (30-day)", "costPlusUsd": 3.60, "goodRxLowUsd": 11.00, "gapPct": 67 },
      { "drug": "Escitalopram 10mg (30-day)", "costPlusUsd": 3.60, "goodRxLowUsd": 9.00, "gapPct": 60 }
    ]
  },
  "limitations": [
    "Biologics and biosimilars excluded from headline drop median (Humira referenced as patent-thicket case context only).",
    "Cash-price snapshots reflect Q1-Q2 2026 publicly posted pharmacy prices; insurance-negotiated and 340B prices may differ materially.",
    "OTC-equivalent strengths excluded from prescription-strength price tracks where dual-availability exists.",
    "Pre-generic brand price uses last-recorded year before first ANDA where wholesale acquisition cost was unavailable.",
    "Stalled-generic 12-month threshold is a heuristic; some cases unwind by month 24 (notably albuterol HFA, partial)."
  ],
  "attribution": "Cite as: RxGrab 2026 Brand-to-Generic Patent Cliff Audit, https://rxgrab.com/research/brand-to-generic-patent-cliff-2026/ (CC-BY 4.0)."
}