plasminogen, human-tvmh (Ryplazim)
plasminogen, human-tvmh is an FDA-licensed reference biologic from Kedrion Biopharma Inc..
Reference product
Ryplazim plasminogen, human-tvmh
Kedrion Biopharma Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Molecular structure
Experimental 3D structure for plasminogen, human-tvmh from the RCSB Protein Data Bank (PDB 4DUR).
Interactive biological assembly from PDB entry 4DUR. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
First licensure
Date plasminogen, human-tvmh was first licensed by the FDA.
5 yr 4 mo ago
Reference approval
Approval date of the reference plasminogen, human-tvmh product.
5 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 9 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 6 yr 10 mo
plasminogen, human-tvmh: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for plasminogen, human-tvmh.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
