| { |
| "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)." |
| } |
|
|
