Biologic Patent Landscapes

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We have compiled reports detailing the patents and regulatory exclusivities protecting FDA-approved biologics in the United States.

The reports describe the patents by:
  • patent number,
  • claim coverage, and
  • expiration date

The status of ongoing patent challenges are also described.

Regulatory exclusivities are described by type (data, orphan, and pediatric) and expiration date.

Follow-ons approved or in development are also reported.

Because the FDA does not publish an Orange Book for biologics, Biologic Patent Landscapes reports are a unique resource.

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