Fda Drug Competition

Orange Book Generic Entry Timeline

orange_book_generic_entry_timeline

Read-onlyIdempotent

Chronologically summarize FDA-approved ANDA applications matching an ingredient or trade name, deduplicated across strengths and products. Returns first approval dates, applicants, dosage forms, TE codes, and active-product counts for generic-entry analysis.

Input Schema

TableJSON Schema

Name	Required	Description
`drug`	Yes
`limit`	No	Unique ANDA applications (1-100, default 50).
`include_discontinued`	No	Include applications with only DISCN products (default true).

Output Schema

TableJSON Schema

Name	Required	Description	Default
`source`	Yes
`returned`	Yes
`dataset_note`	No
`dataset_stale`	No
`anda_approvals`	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

A4.3/5.0

Behavior4/5

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

Annotations already declare readOnlyHint, idempotentHint, and non-destructive behavior, so the safety profile is covered. The description adds meaningful behavioral detail beyond annotations: results are deduplicated across strengths and products, ordered chronologically, and include specific fields like first approval dates, TE codes, and active-product counts.

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 carry all necessary information with no filler. The first sentence front-loads the core function and dedup behavior; the second enumerates return fields. Every clause earns its place.

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

Completeness5/5

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

Given the output schema exists and annotations cover safety and idempotency, the description provides the missing context: what the tool returns, how it deduplicates, and what input means. No critical information for selecting or invoking the tool is absent.

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

Parameters4/5

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

The schema covers limit and include_discontinued with descriptions, but the required drug parameter has no schema description. The description compensates by clarifying that drug matches an ingredient or trade name, which is essential for correct invocation.

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 specifies a precise operation (chronologically summarize), a clear resource (FDA-approved ANDA applications matching ingredient or trade name), and a distinctive analytic goal (generic-entry analysis). It is clearly differentiated from sibling tools like orange_book_product_search or orange_book_application_detail by its timeline focus and deduplication behavior.

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 phrase 'for generic-entry analysis' implies when the tool should be used, and the name signals it is the generic counterpart to purple_book_biosimilar_entry_timeline. However, it never explicitly names alternatives or states when not to use this tool, so the agent must infer routing from context.

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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