plasminogen, human-tvmh (Ryplazim)
plasminogen, human-tvmh is an FDA-licensed reference biologic from Kedrion Biopharma Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Ryplazim plasminogen, human-tvmh
Kedrion Biopharma Inc.
- Approved
- Jun 04, 2021
- 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 — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for plasminogen, human-tvmh, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
94 yr 6 mo ago
First licensure
Date plasminogen, human-tvmh was first licensed by the FDA.
5 yr 2 mo ago
Reference approval
Approval date of the reference plasminogen, human-tvmh product.
5 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 11 mo
Frequently asked questions
Are there biosimilars approved for plasminogen, human-tvmh (Ryplazim)?
No 351(k) biosimilars or interchangeable biosimilars referencing plasminogen, human-tvmh are listed in the FDA Purple Book yet.
When does plasminogen, human-tvmh (Ryplazim) lose reference-product exclusivity?
plasminogen, human-tvmh's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending June 4, 1933.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.