FDA Purple Book · Reference family
BCG Vaccine (Mycobax)
BCG Vaccine is an FDA-licensed reference biologic from Sanofi Pasteur Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2000
Reference approved
Reference product
351(a)BLA 103942
Mycobax BCG Vaccine
Sanofi Pasteur Limited
- Approved
- Feb 24, 2000
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for BCG Vaccine, in chronological order.
Reference approval
Approval date of the reference BCG Vaccine product.
26 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for BCG Vaccine (Mycobax)?
No 351(k) biosimilars or interchangeable biosimilars referencing BCG Vaccine are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.