Fda Drug Competition

Orange Book Reference Drug Landscape

orange_book_reference_drug_landscape

Read-onlyIdempotent

Map FDA Orange Book reference listed drugs and reference standards to approved ANDA competition by dosage-form/route and therapeutic-equivalence code. Returns reference applications, ANDA counts and applicants, and TE-code groupings.

Input Schema

TableJSON Schema

Name	Required	Description
`drug`	Yes
`limit`	No	Dosage-form/route groups (1-100, default 25).
`include_discontinued`	No	Include DISCN products (default false).

Output Schema

TableJSON Schema

Name	Required	Description	Default
`drug`	Yes
`groups`	Yes
`source`	Yes
`returned`	Yes
`dataset_note`	No
`dataset_stale`	No
`interpretation`	Yes
`dataset_updated`	No
`dataset_age_days`	No

Schema Changelog

Changes observed during successful MCP inspections. Dates show when Glama detected each change.

Changed3 schema fields changedSep 2, 2026
- addedOutput schema / properties / dataset_age_days
```
Added value: +{
+  "type": [
+    "number",
+    "null"
+  ]
+}
```
- addedOutput schema / properties / dataset_note
```
Added value: +{
+  "type": "string"
+}
```
- addedOutput schema / properties / dataset_stale
```
Added value: +{
+  "type": "boolean"
+}
```
AddedAug 6, 2026

TDQS

A3.7/5.0

Behavior3/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already declare this as read-only, open-world, idempotent, and non-destructive, so the bar for additional behavioral disclosure is lower. The description adds what outputs are returned (reference applications, ANDA counts/applicants, TE-code groupings) and the grouping dimensions, but does not disclose limitations such as data currency, filtering behavior, or how 'open-world' results may vary.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Two sentences with no filler. The primary action and target are front-loaded, and the return payload is summarized compactly. Every phrase earns its place.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

Given the rich annotations (read-only, idempotent, open-world), an output schema, and a clear two-sentence description, the definition is largely complete for a safe query tool. It loses a point only because it does not guide selection among the numerous closely related Orange Book tools and leaves the drug parameter format unspecified.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters2/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema coverage is 67%, with 'limit' and 'include_discontinued' adequately described in the schema, but the required 'drug' parameter has no schema description and the tool description only hints at 'reference listed drugs' without specifying acceptable formats (brand name, generic name, NDC). The description adds little clarity for the core parameter, leaving agents to guess how to pass the drug value.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description uses a specific verb ('Map') and identifies the exact resource (FDA Orange Book reference listed drugs and reference standards) and the mapping target (approved ANDA competition by dosage-form/route and TE-code). It also lists the concrete returns, making the tool's function distinct from related Orange Book siblings like product_search or application_detail.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines3/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The description implies the use case of analyzing competitive ANDA landscape for reference drugs, but it does not explicitly state when to choose this tool over the many overlapping Orange Book siblings (e.g., orange_book_competition_profile, orange_book_generic_entry_timeline) or when not to use it. Guidance is only implicit in the 'landscape' framing.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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