FDA Purple Book · Reference family
BCG Live (TheraCys)
BCG Live 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 103943
TheraCys BCG Live
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 Live, in chronological order.
Reference approval
Approval date of the reference BCG Live product.
26 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for BCG Live (TheraCys)?
No 351(k) biosimilars or interchangeable biosimilars referencing BCG Live are listed in the FDA Purple Book yet.
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