# getOrangeBookPatents

**Identifier:** `openfda_getOrangeBookPatents`

**Provider:** [OpenFDA](https://kirha.com/providers/openfda.md)

Get the Orange Book patents and regulatory exclusivities listed for one NDA (expiry dates, substance/product/method-of-use flags, use codes, pediatric extensions marked *PED), its products with therapeutic equivalence codes, and the approved ANDA generics of the same ingredient, dosage form and route (count, first generic approval, applicants). Answers loss-of-exclusivity and generic-entry questions. Get the applicationNumber from searchOrangeBook or openfda-mcp searchDrugApprovals.

## Run it with the CLI

```bash
kirha tools run openfda_getOrangeBookPatents \
  --input '{
    "applicationNumber": "NDA209637 or 209637"
  }'
```

`--input` takes a JSON object that matches the input schema. Pass `--input -` to read it from stdin.

## Call it over HTTP

```bash
curl https://api.kirha.com/tools/v1/execute \
  --request POST \
  --header 'Content-Type: application/json' \
  --header 'Authorization: **********' \
  --data '{
  "tool_name": "openfda_getOrangeBookPatents",
  "input": {
    "applicationNumber": "NDA209637 or 209637"
  }
}'
```

Replace the stars with an API key from https://app.kirha.com/api-keys.

## Input schema

```json
{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "properties": {
    "applicationNumber": {
      "description": "e.g. NDA209637 or 209637 (NDA assumed when no prefix)",
      "pattern": "^\\s*(NDA|ANDA|N|A)?\\s*\\d{6}\\s*$",
      "type": "string"
    }
  },
  "required": [
    "applicationNumber"
  ],
  "type": "object"
}
```

## Output schema

```json
{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "additionalProperties": false,
  "properties": {
    "applicant": {
      "type": "string"
    },
    "applicationNumber": {
      "type": "string"
    },
    "approvedGenerics": {
      "additionalProperties": false,
      "description": "ANDAs with the same ingredient and dosage form/route",
      "properties": {
        "applicants": {
          "items": {
            "type": "string"
          },
          "type": "array"
        },
        "applicationCount": {
          "type": "number"
        },
        "applicationNumbers": {
          "items": {
            "type": "string"
          },
          "type": "array"
        },
        "firstApprovalDate": {
          "type": "string"
        },
        "marketedCount": {
          "description": "ANDAs with at least one non-discontinued product",
          "type": "number"
        }
      },
      "required": [
        "applicationCount",
        "marketedCount",
        "applicants",
        "applicationNumbers"
      ],
      "type": "object"
    },
    "context": {
      "type": "string"
    },
    "exclusivities": {
      "items": {
        "additionalProperties": false,
        "properties": {
          "code": {
            "type": "string"
          },
          "description": {
            "type": "string"
          },
          "expiryDate": {
            "type": "string"
          },
          "productNos": {
            "items": {
              "type": "string"
            },
            "type": "array"
          }
        },
        "required": [
          "code",
          "productNos"
        ],
        "type": "object"
      },
      "type": "array"
    },
    "found": {
      "type": "boolean"
    },
    "ingredient": {
      "type": "string"
    },
    "lastExclusivityExpiry": {
      "type": "string"
    },
    "lastPatentExpiry": {
      "type": "string"
    },
    "patents": {
      "items": {
        "additionalProperties": false,
        "properties": {
          "delisted": {
            "type": "boolean"
          },
          "drugProduct": {
            "type": "boolean"
          },
          "drugSubstance": {
            "type": "boolean"
          },
          "expiryDate": {
            "type": "string"
          },
          "patentNo": {
            "description": "Suffix *PED = 6-month pediatric extension of that patent",
            "type": "string"
          },
          "productNos": {
            "items": {
              "type": "string"
            },
            "type": "array"
          },
          "submissionDate": {
            "type": "string"
          },
          "useCodes": {
            "description": "Method-of-use codes (U-nnnn); empty = no method-of-use claim",
            "items": {
              "type": "string"
            },
            "type": "array"
          }
        },
        "required": [
          "patentNo",
          "drugSubstance",
          "drugProduct",
          "useCodes",
          "delisted",
          "productNos"
        ],
        "type": "object"
      },
      "type": "array"
    },
    "products": {
      "items": {
        "additionalProperties": false,
        "properties": {
          "approvalDate": {
            "type": "string"
          },
          "marketingStatus": {
            "type": "string"
          },
          "productNo": {
            "type": "string"
          },
          "referenceListedDrug": {
            "type": "boolean"
          },
          "strength": {
            "type": "string"
          },
          "teCode": {
            "type": "string"
          }
        },
        "required": [
          "productNo",
          "strength",
          "approvalDate",
          "referenceListedDrug",
          "marketingStatus"
        ],
        "type": "object"
      },
      "type": "array"
    },
    "protectionEndDate": {
      "description": "Latest listed patent or exclusivity expiry",
      "type": "string"
    },
    "tradeNames": {
      "items": {
        "type": "string"
      },
      "type": "array"
    }
  },
  "required": [
    "context",
    "applicationNumber",
    "found"
  ],
  "type": "object"
}
```

## Related tools

Other OpenFDA tools that this tool refers to, or that refer to it.

- [`searchDrugApprovals`](https://kirha.com/providers/openfda/searchDrugApprovals.md)
- [`searchOrangeBook`](https://kirha.com/providers/openfda/searchOrangeBook.md)

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