{ "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" ], "dataProvenance": "SOURCED: 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, and GoodRx public coupon data. DERIVED: savings and patent-cliff aggregates computed from those sources. Informational only, not medical or financial advice." }, "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, "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": 3.6, "goodRxLowUsd": 9.83, "gapPct": 63 }, { "drug": "Sertraline 50mg (30-day)", "costPlusUsd": 4.2, "goodRxLowUsd": 11, "gapPct": 62 }, { "drug": "Metformin ER 500mg (30-day)", "costPlusUsd": 3.4, "goodRxLowUsd": 12.5, "gapPct": 73 }, { "drug": "Duloxetine 60mg (30-day)", "costPlusUsd": 5.1, "goodRxLowUsd": 20.4, "gapPct": 75 }, { "drug": "Sildenafil 100mg (10ct)", "costPlusUsd": 5.5, "goodRxLowUsd": 45, "gapPct": 88 }, { "drug": "Finasteride 5mg (30-day)", "costPlusUsd": 3.6, "goodRxLowUsd": 15, "gapPct": 76 }, { "drug": "Donepezil 10mg (30-day)", "costPlusUsd": 3.6, "goodRxLowUsd": 11, "gapPct": 67 }, { "drug": "Escitalopram 10mg (30-day)", "costPlusUsd": 3.6, "goodRxLowUsd": 9, "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)." }