Purple Book reference family · 351(a) biologic
immune globulin subcutaneous, human-klhw (Xembify)
immune globulin subcutaneous, human-klhw is an FDA-licensed reference biologic from Grifols Therapeutics LLC.
351(a) biologicBLA 125683 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 125683
Xembify immune globulin subcutaneous, human-klhw
Grifols Therapeutics LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference immune globulin subcutaneous, human-klhw product.
7 yr 2 mo ago
immune globulin subcutaneous, human-klhw: 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 immune globulin subcutaneous, human-klhw.
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