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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1977
Reference approved
Reference product
Bayhep B, Hyperhep B S/D Hepatitis B Immune Globulin (Human)
Grifols Therapeutics LLC
- Approved
- Sep 23, 1977
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Hepatitis B Immune Globulin (Human), in chronological order.
Reference approval
Approval date of the reference Hepatitis B Immune Globulin (Human) product.
49 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Hepatitis B Immune Globulin (Human) (Bayhep B, Hyperhep B S/D)?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis B Immune Globulin (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.