Unofficial FDA MCP Server

A comprehensive Model Context Protocol (MCP) server that provides advanced pharmaceutical intelligence through the FDA's openFDA database, Orange Book, and Purple Book. This server combines real-time data access with locally-cached patent, exclusivity, and biosimilar data to deliver actionable insights for:

• Drug Safety & Adverse Events: Real-time FAERS data and safety alerts

• Patent Intelligence: Patent cliffs, loss of exclusivity (LOE) analysis, generic entry forecasting

• Therapeutic Equivalents: AB-rated generic alternatives and substitutability

• Biosimilar Intelligence: Biosimilar approvals and interchangeability designations

• Regulatory Intelligence: FDA approvals, recalls, and drug shortages

• Competitive Analysis: Market exclusivity periods and competitive landscape

Key Features:

• Fast Queries: <10ms response time for Orange/Purple Book data after initial setup

• Auto-Updates: Automatic monthly data downloads and caching

• Comprehensive Coverage: 47,000+ drug products, 21,000+ patents, 2,000+ biologics

• Zero Configuration: Works out of the box with automatic data downloads

Usage

What's New: Orange Book & Purple Book Integration

This server now includes comprehensive FDA Orange Book and Purple Book data for pharmaceutical intelligence:

Orange Book (Drug Patents & Generic Equivalents)

• 47,486 drug products with approval dates and marketing status

• 21,126 patents with expiration dates and use codes

• 2,444 exclusivity periods (orphan, pediatric, new clinical studies, etc.)

• Therapeutic Equivalence (TE) Codes: Identify AB-rated generics pharmacists can substitute

• Patent Cliff Analysis: Forecast generic entry dates and loss of exclusivity

Purple Book (Biologics & Biosimilars)

• 2,168 biological products including reference products and biosimilars

• Interchangeability designations: Know which biosimilars can be substituted by pharmacists

• Licensing dates and applicants for all biologics

• Reference product mapping: Links biosimilars to their reference products

• Market exclusivity tracking including orphan drug exclusivity

API Reference

Tool: fda_info

Unified tool for FDA drug information lookup, safety data, and pharmaceutical intelligence.

Parameters

Methods

OpenFDA API Methods

Unified Drug Lookup (lookup_drug)

Search for comprehensive drug information with different search types and optional field targeting:

Comprehensive Search (All Fields):

Field-Specific Search:

Complex Boolean Query:

Drug Labels and Prescribing Information:

Label Field-Specific Search:

Adverse Events and Safety Data:

Drug Recalls and Safety Alerts:

Drug Shortages:

Orange Book Methods (Patents & Generic Equivalents)

The Orange Book provides information on drug patents, exclusivity, and therapeutic equivalence. Data is automatically downloaded and cached locally for fast queries (<10ms after initial setup).

Search Orange Book (search_orange_book)

Search for brand and generic drug products by name:

Returns brand products and generic alternatives with approval dates, applicants, TE codes, and marketing status.

Get Therapeutic Equivalents (get_therapeutic_equivalents)

Find AB-rated generic equivalents that are therapeutically equivalent to the reference listed drug:

Returns the Reference Listed Drug (RLD) plus all AB-rated and non-AB generics. AB-rated generics can be substituted by pharmacists.

Get Patent & Exclusivity Data (get_patent_exclusivity)

Look up all patents and exclusivity periods for a drug by NDA number:

Returns active patents with expiration dates, patent use codes, and FDA exclusivity periods.

Analyze Patent Cliff (analyze_patent_cliff)

Analyze when a drug will lose patent/exclusivity protection and face generic competition:

Returns patent timeline, next expiration dates, estimated generic entry date, and years until loss of exclusivity (LOE).

Purple Book Methods (Biologics & Biosimilars)

The Purple Book provides information on licensed biological products and biosimilar/interchangeable products. Data is automatically downloaded monthly and cached locally.

Search Purple Book (search_purple_book)

Search for biological products and their biosimilars:

Returns the reference biological product and all approved biosimilars with licensing dates, applicants, and interchangeability status.

Get Biosimilar Interchangeability (get_biosimilar_interchangeability)

Check which biosimilars are designated as interchangeable (can be substituted by pharmacists):

Returns interchangeable biosimilars (pharmacy can substitute without prescriber) and similar but non-interchangeable biosimilars (requires new prescription).

Complex Query Syntax

The FDA MCP Server supports powerful openFDA query syntax for advanced searches:

Boolean Operators

AND Queries - Find results matching multiple criteria:

OR Queries - Find results matching any criteria:

Wildcard Patterns

Prefix wildcards - Find names starting with a pattern:

General wildcards - Find any field containing a pattern:

Range Queries

Age ranges - Find adverse events for specific age groups:

Date ranges - Find events within date ranges:

Special Modifiers

Field exists - Find records where a field has any value:

Field missing - Find records where a field is empty:

Complex Multi-Field Examples

Advanced adverse events - Serious events in elderly patients:

Grouped conditions - Multiple drug names with conditions:

Geographic filtering - Events by country with drug and severity:

Usage Examples

Comprehensive Drug Search (All Fields)

Field-Specific Searches

General Search Fields (34 available):

Adverse Events Fields (66 available):

Label Search Fields (167 available):

Recalls Fields (39 available):

Shortages Fields (44 available):

Detailed Drug Label

Safety and Adverse Events

Drug Recalls

Drug Shortages

Orange Book - Patents and Generic Equivalents

Purple Book - Biologics and Biosimilars

Real-World Example Results:

• Ozempic (semaglutide): 72 active patents, first patent expires Aug 2025, but generic entry estimated Jan 2028 (2.1 years away)

• Humira (adalimumab): 10 biosimilars approved, only Hyrimoz is interchangeable (since April 2025)

• Prozac (fluoxetine): All patents expired, 46 AB-rated generic equivalents available

• Trikafta: 109 active patents, orphan exclusivity until 2031, extensive patent protection

Available Search Fields

The API supports searching across FDA database fields total. Use field-specific parameters for targeted searches:

• fields_for_general: 34 fields for general drug data searches

• fields_for_adverse_events: 66 fields for adverse events searches

• fields_for_label: 167 fields for drug label searches

• fields_for_recalls: 39 fields for recalls and enforcement searches

• fields_for_shortages: 44 fields for drug shortages searches

OpenFDA Section (16 fields)

• openfda.application_number - FDA application number

• openfda.brand_name - Brand/trade name of the drug

• openfda.generic_name - Generic name of the drug

• openfda.manufacturer_name - Name of the manufacturer

• openfda.nui - Numeric identifier for ingredients

• openfda.package_ndc - Package-level National Drug Code

• openfda.pharm_class_cs - Chemical structure pharmacologic class

• openfda.pharm_class_epc - Established pharmacologic class

• openfda.pharm_class_pe - Physiologic effect pharmacologic class

• openfda.pharm_class_moa - Mechanism of action pharmacologic class

• openfda.product_ndc - Product-level National Drug Code

• openfda.route - Route of administration

• openfda.rxcui - RxNorm concept unique identifier

• openfda.spl_id - Structured Product Labeling identifier

• openfda.spl_set_id - SPL document set identifier

• openfda.substance_name - Name of the active substance

• openfda.unii - Unique Ingredient Identifier

Products Section (9 fields)

• products.active_ingredients.name - Name of active ingredient

• products.active_ingredients.strength - Strength of active ingredient

• products.dosage_form - Dosage form (e.g., "TABLET", "CAPSULE")

• products.marketing_status - Marketing status (e.g., "Discontinued", "Prescription")

• products.product_number - Product number within application

• products.reference_drug - Reference drug designation

• products.reference_standard - Reference standard designation

• products.route - Route of administration

• products.te_code - Therapeutic equivalence evaluation code

Submissions Section (10+ fields)

• submissions.application_docs - Application documentation

• submissions.review_priority - Review priority designation

• submissions.submission_class_code - Submission classification code

• submissions.submission_class_code_description - Description of submission class

• submissions.submission_number - Sequential submission number

• submissions.submission_property_type.code - Property type code

• submissions.submission_public_notes - Public notes about submission

• submissions.submission_status - Current status of submission

• submissions.submission_status_date - Date of status change

• submissions.submission_type - Type of submission

Usage Examples by Field Type

Search by Marketing Status:

Search by Manufacturer:

Search by Dosage Form:

Search by Active Ingredient:

Response Format

All responses include:

Search Tips

Drug Names

• Use both generic names (e.g., "acetaminophen") and brand names (e.g., "Tylenol")

• Try different name variations if initial search returns no results

• Include common spellings and abbreviations

• Use wildcards for partial matches (e.g., child* for children's medications)

Search Types

• general: Comprehensive search across all FDA database fields (34 fields available)

• label: Detailed prescribing information and FDA-approved labels (167 fields available)

• adverse_events: Safety data and adverse reaction reports (66 fields available)

• recalls: Drug recalls and safety alerts (39 fields available)

• shortages: Current drug supply shortages and availability (44 fields available)

Complex Query Strategies

• Boolean Logic: Combine conditions with AND/OR operators

• Field Targeting: Use openfda.field_name:value syntax for precise searches

• Range Queries: Use [min+TO+max] for age, date, or numeric ranges

• Wildcards: Use * for pattern matching (*5*, MEF*)

• Special Modifiers: Use _exists_:field or _missing_:field for data completeness

Field-Specific Searching

• Use fields_for_general for general drug data (34 options)

• Use fields_for_adverse_events for adverse events (66 options)

• Use fields_for_label for drug label searches (167 options)

• Use fields_for_recalls for recalls and enforcement (39 options)

• Use fields_for_shortages for drug shortages (44 options)

• Examples: products.marketing_status, patient.reaction.reactionmeddrapt, warnings, recalling_firm, status

• Enables precise queries like finding discontinued drugs, specific adverse reactions, label warnings, recall classifications, or shortage statuses

Advanced Query Examples

• Multi-condition: drug:aspirin+AND+form:TABLET+AND+status:active

• Age-specific: patient.patientonsetage:[18+TO+65] for adults

• Geographic: occurcountry:US+AND+serious:1 for US serious events

• Time-based: receiptdate:[2023-01-01+TO+2023-12-31] for 2023 data