Coagulation Factor IX (Human) (Alphanine, Alphanine Hp, Alphanine Sd)
Coagulation Factor IX (Human) is an FDA-licensed reference biologic from Grifols Biologicals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1990
Reference approved
Reference product
Alphanine, Alphanine Hp, Alphanine Sd Coagulation Factor IX (Human)
Grifols Biologicals LLC
- Approved
- Dec 31, 1990
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor IX (Human), in chronological order.
Reference approval
Approval date of the reference Coagulation Factor IX (Human) product.
36 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
29 yr ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor IX (Human) (Alphanine, Alphanine Hp, Alphanine Sd)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor IX (Human) 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.