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"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)."
}
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