Assyro AI
FDA Purple Book · Reference family

Coccidioides immitis Spherule-Derived Skin Test Antigen (Spherusol)

Coccidioides immitis Spherule-Derived Skin Test Antigen is an FDA-licensed reference biologic from Nielsen Bioscience, Inc. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2011

Reference approved

Reference product

351(a)BLA 125354

Spherusol Coccidioides immitis Spherule-Derived Skin Test Antigen

Nielsen Bioscience, Inc

Approved
Jul 29, 2011
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Coccidioides immitis Spherule-Derived Skin Test Antigen, in chronological order.

  1. Reference approval

    Approval date of the reference Coccidioides immitis Spherule-Derived Skin Test Antigen product.

    15 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for Coccidioides immitis Spherule-Derived Skin Test Antigen (Spherusol)?

No 351(k) biosimilars or interchangeable biosimilars referencing Coccidioides immitis Spherule-Derived Skin Test Antigen are listed in the FDA Purple Book yet.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool