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README.md

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+---
+license: cc-by-4.0
+language:
+  - en
+pretty_name: "RxGrab 2026 Brand-to-Generic Patent Cliff Audit"
+tags:
+  - pharmacy
+  - drug-pricing
+  - generics
+  - patent-cliff
+  - healthcare
+size_categories:
+  - n<1K
+---
+
+# RxGrab 2026 Brand-to-Generic Patent Cliff Audit
+
+Aggregated cost-drop, time-to-generic, and stalled-generic audit covering 50 high-volume US prescription drugs across 24 therapeutic categories.
+
+- **License:** CC-BY 4.0
+- **DOI:** [10.5281/zenodo.20632747](https://doi.org/10.5281/zenodo.20632747)
+- **Source study:** https://rxgrab.com/research/brand-to-generic-patent-cliff-2026/
+- **Author:** Vincent Wesley Couey ([ORCID 0009-0005-6869-308X](https://orcid.org/0009-0005-6869-308X)) · published via RxGrab (rxgrab.com), part of the Lattice research network.
+
+## What's in it
+Files: `data.json`. Main table `stalledGenerics` (7 rows): `brand`, `generic`, `category`, `firstGenericYear`, `twelveMonthRetainedPct`, `stallDriver`.
+
+## Method
+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.
+
+## Citation
+> Couey, V. W. (2026). *RxGrab 2026 Brand-to-Generic Patent Cliff Audit* [Data set]. RxGrab. https://doi.org/10.5281/zenodo.20632747
+
+CC-BY 4.0 — free to use with attribution. Informational and research use only. Not medical advice; verify against the primary source and a licensed professional before relying on any value. Dated snapshot; verify current values before relying on them.

data.json

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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)."
+}