Hepatitis B Vaccine (Recombinant), Adjuvanted (Heplisav-B)
Hepatitis B Vaccine (Recombinant), Adjuvanted is an FDA-licensed reference biologic from Dynavax Technologies Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Heplisav-B Hepatitis B Vaccine (Recombinant), Adjuvanted
Dynavax Technologies Corporation
- Approved
- Nov 09, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Hepatitis B Vaccine (Recombinant), Adjuvanted, in chronological order.
Reference approval
Approval date of the reference Hepatitis B Vaccine (Recombinant), Adjuvanted product.
8 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Hepatitis B Vaccine (Recombinant), Adjuvanted (Heplisav-B)?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis B Vaccine (Recombinant), Adjuvanted are listed in the FDA Purple Book yet.
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