Purple Book reference family · 351(a) biologic
Hepatitis B Immune Globulin (Human) (Bayhep B, Hyperhep B S/D)
Hepatitis B Immune Globulin (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC.
351(a) biologicBLA 101146 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1977
Reference product
Originator biologic
351(a)BLA 101146
Bayhep B, Hyperhep B S/D Hepatitis B Immune Globulin (Human)
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 Hepatitis B Immune Globulin (Human) product.
49 yr 9 mo ago
Hepatitis B Immune Globulin (Human): 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 Hepatitis B Immune Globulin (Human).
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