{
  "retrieved_utc": "2026-10-09",
  "method_version": "1.0",
  "sources": [
    {
      "title": "FDA, 2019 First Generic Drug Approvals",
      "url": "https://www.fda.gov/drugs/first-generic-drug-approvals/2019-first-generic-drug-approvals",
      "supports": "Rows 103\u2013104: ANDAs 210013 and 210128; December 23, 2019. The introductory availability note qualifies the meaning of approval."
    },
    {
      "title": "FDA, Orange Book API: NDA 202155",
      "url": "https://api.fda.gov/drug/orangebook.json?search=products.application_number:202155&limit=10",
      "supports": "Product 001: patent 9326945, 2031-02-24; separate 9326945*PED entry, 2031-08-24. Snapshot retrieved October 9, 2026."
    },
    {
      "title": "Bristol Myers Squibb, 2025 Form 10-K",
      "url": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000004/bmy-20251231.htm",
      "supports": "Item 1, estimated minimum market exclusivity table, footnote (e): the company reports permission for settling generics to launch in 2028, subject to additional challenges. This is an issuer statement, not an independently construed agreement."
    }
  ],
  "fda_response": {
    "meta": {
      "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
      "terms": "https://open.fda.gov/terms/",
      "license": "https://open.fda.gov/license/",
      "last_updated": "2026-10-07",
      "results": {
        "skip": 0,
        "limit": 10,
        "total": 3
      }
    },
    "results": [
      {
        "approval_date": "20121228",
        "exclusivity": [
          {
            "exclusivity_code": "NPP",
            "exclusivity_expiration_date": "20280417"
          },
          {
            "exclusivity_code": "PED",
            "exclusivity_expiration_date": "20281017"
          }
        ],
        "patents": [
          {
            "patent_number": "6967208",
            "expiration_date": "20261121",
            "drug_substance_flag": true,
            "drug_product_flag": true,
            "patent_use_code": "U-1729",
            "patent_submission_date": "20130125"
          },
          {
            "patent_number": "6967208*PED",
            "expiration_date": "20270521"
          },
          {
            "patent_number": "9326945",
            "expiration_date": "20310224",
            "drug_product_flag": true,
            "patent_submission_date": "20160526"
          },
          {
            "patent_number": "9326945*PED",
            "expiration_date": "20310824"
          }
        ],
        "product_number": "001",
        "products": [
          {
            "active_ingredients": [
              {
                "name": "APIXABAN",
                "strength": "2.5MG"
              }
            ],
            "brand_name": "ELIQUIS",
            "application_name": "BRISTOL MYERS SQUIBB",
            "application_type": "N",
            "application_number": "202155",
            "therapeutic_equivalence_codes": [
              "AB"
            ],
            "reference_listed_drug": true,
            "reference_standard": false,
            "marketing_status": "HUMAN PRESCRIPTION DRUG",
            "application_full_name": "BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE",
            "dosage_form": "TABLET",
            "route": "ORAL"
          }
        ]
      },
      {
        "approval_date": "20121228",
        "exclusivity": [
          {
            "exclusivity_code": "NPP",
            "exclusivity_expiration_date": "20280417"
          },
          {
            "exclusivity_code": "PED",
            "exclusivity_expiration_date": "20281017"
          }
        ],
        "patents": [
          {
            "patent_number": "6967208",
            "expiration_date": "20261121",
            "drug_substance_flag": true,
            "drug_product_flag": true,
            "patent_use_code": "U-1200",
            "patent_submission_date": "20130125"
          },
          {
            "patent_number": "6967208*PED",
            "expiration_date": "20270521"
          },
          {
            "patent_number": "9326945",
            "expiration_date": "20310224",
            "drug_product_flag": true,
            "patent_submission_date": "20160526"
          },
          {
            "patent_number": "9326945*PED",
            "expiration_date": "20310824"
          }
        ],
        "product_number": "002",
        "products": [
          {
            "active_ingredients": [
              {
                "name": "APIXABAN",
                "strength": "5MG"
              }
            ],
            "brand_name": "ELIQUIS",
            "application_name": "BRISTOL MYERS SQUIBB",
            "application_type": "N",
            "application_number": "202155",
            "therapeutic_equivalence_codes": [
              "AB"
            ],
            "reference_listed_drug": true,
            "reference_standard": true,
            "marketing_status": "HUMAN PRESCRIPTION DRUG",
            "application_full_name": "BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE",
            "dosage_form": "TABLET",
            "route": "ORAL"
          }
        ]
      },
      {
        "approval_date": "20250417",
        "exclusivity": [
          {
            "exclusivity_code": "NS",
            "exclusivity_expiration_date": "20280417"
          },
          {
            "exclusivity_code": "PED",
            "exclusivity_expiration_date": "20281017"
          }
        ],
        "patents": [
          {
            "patent_number": "6967208",
            "expiration_date": "20261121",
            "drug_substance_flag": true,
            "drug_product_flag": true,
            "patent_use_code": "U-4179",
            "patent_submission_date": "20250516"
          },
          {
            "patent_number": "6967208*PED",
            "expiration_date": "20270521"
          },
          {
            "patent_number": "9326945",
            "expiration_date": "20310224",
            "drug_product_flag": true,
            "patent_submission_date": "20250516"
          },
          {
            "patent_number": "9326945*PED",
            "expiration_date": "20310824"
          }
        ],
        "product_number": "003",
        "products": [
          {
            "active_ingredients": [
              {
                "name": "APIXABAN",
                "strength": "0.5MG"
              }
            ],
            "brand_name": "ELIQUIS",
            "application_name": "BRISTOL MYERS SQUIBB",
            "application_type": "N",
            "application_number": "202155",
            "reference_listed_drug": true,
            "reference_standard": true,
            "marketing_status": "HUMAN PRESCRIPTION DRUG",
            "application_full_name": "BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE",
            "dosage_form": "TABLET, FOR SUSPENSION",
            "route": "ORAL"
          }
        ]
      }
    ]
  },
  "platform_snapshot": {
    "generated_utc": "2026-09-27T18:48:33Z",
    "record": {
      "inn": "apixaban",
      "patent_cliff": "2041-05-22",
      "fda_patents": [
        {
          "patent_no": "6967208",
          "expiry": "2026-11-21",
          "drug_substance": false,
          "drug_product": false,
          "use_code": "U-4180",
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        },
        {
          "patent_no": "6967208*PED",
          "expiry": "2027-05-21",
          "drug_substance": false,
          "drug_product": false,
          "use_code": null,
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        },
        {
          "patent_no": "11896586",
          "expiry": "2040-11-22",
          "drug_substance": false,
          "drug_product": false,
          "use_code": "U-4180",
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        },
        {
          "patent_no": "11896586*PED",
          "expiry": "2041-05-22",
          "drug_substance": false,
          "drug_product": false,
          "use_code": null,
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        }
      ],
      "fda_exclusivity": [
        {
          "code": "NP",
          "expiry": "2028-04-17",
          "description": "New Product \u2014 3 years",
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        },
        {
          "code": "PED",
          "expiry": "2028-10-17",
          "description": "Paediatric Extension \u2014 6 months",
          "brand": "ELIQUIS",
          "appl_no": "NDA220073"
        }
      ],
      "next_exclusivity_expiry": {
        "code": "NP",
        "expiry": "2028-04-17",
        "description": "New Product \u2014 3 years",
        "brand": "ELIQUIS",
        "appl_no": "NDA220073"
      },
      "last_updated": "2026-09-27"
    },
    "limitation": "The inspected platform snapshot omits NDA 202155. Do not treat the substance-level latest date as complete application coverage."
  }
}