Purple Book reference family · 351(a) biologic
BCG Vaccine (Mycobax)
BCG Vaccine is an FDA-licensed reference biologic from Sanofi Vaccines Canada Ltd..
351(a) biologicBLA 103942 Sanofi Vaccines Canada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103942
Mycobax BCG Vaccine
Sanofi Vaccines Canada Ltd.
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 BCG Vaccine product.
26 yr 10 mo ago
BCG Vaccine: 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 BCG Vaccine.
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