tagraxofusp-erzs (Elzonris)
tagraxofusp-erzs is an FDA-licensed reference biologic from Stemline Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Elzonris tagraxofusp-erzs
Stemline Therapeutics, Inc.
- Approved
- Dec 21, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tagraxofusp-erzs, in chronological order.
Reference approval
Approval date of the reference tagraxofusp-erzs product.
7 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
7 mo ago
Frequently asked questions
Are there biosimilars approved for tagraxofusp-erzs (Elzonris)?
No 351(k) biosimilars or interchangeable biosimilars referencing tagraxofusp-erzs are listed in the FDA Purple Book yet.
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.