Assyro AI
FDA Purple Book · Reference family

Thrombin topical (Recombinant) (Recothrom)

Thrombin topical (Recombinant) is an FDA-licensed reference biologic from Baxter Healthcare Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2008

Reference approved

Reference product

351(a)BLA 125248

Recothrom Thrombin topical (Recombinant)

Baxter Healthcare Corporation

Approved
May 23, 2008
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Thrombin topical (Recombinant), in chronological order.

  1. Reference approval

    Approval date of the reference Thrombin topical (Recombinant) product.

    18 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Thrombin topical (Recombinant) (Recothrom)?

No 351(k) biosimilars or interchangeable biosimilars referencing Thrombin topical (Recombinant) 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