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FDA Orange Book

Approved drug products with patent and exclusivity information.

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Entry · The data

Approved drug products with patent and exclusivity information.

Why GTM teams care

Authoritative source on drug approvals, patents, and market exclusivity.

Best use cases

  1. Track drug approvals and patent expirations
  2. Identify generic entry opportunities
  3. Monitor competitive product landscape
Entry · Public dataset

Dataset details

Steward / publisher
FDA
Jurisdiction
us-federal
License
Public Domain
Access method
bulk-download
Auth required
none
Record count
~20K approved products
Entry · Request

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