immune globulin subcutaneous, human-klhw (Xembify)
immune globulin subcutaneous, human-klhw is an FDA-licensed reference biologic from Grifols Therapeutics LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Xembify immune globulin subcutaneous, human-klhw
Grifols Therapeutics LLC
- Approved
- Jul 03, 2019
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for immune globulin subcutaneous, human-klhw, in chronological order.
Reference approval
Approval date of the reference immune globulin subcutaneous, human-klhw product.
7 yr ago
Frequently asked questions
Are there biosimilars approved for immune globulin subcutaneous, human-klhw (Xembify)?
No 351(k) biosimilars or interchangeable biosimilars referencing immune globulin subcutaneous, human-klhw are listed in the FDA Purple Book yet.
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