Purple Book reference family · 351(a) biologic
interferon beta-1b (Betaseron)
interferon beta-1b is an FDA-licensed reference biologic from Bayer HealthCare Pharmaceuticals Inc..
351(a) biologicBLA 103471 Bayer HealthCare Pharmaceuticals Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1993
Reference product
Originator biologic
351(a)BLA 103471
Betaseron interferon beta-1b
Bayer HealthCare Pharmaceuticals Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference interferon beta-1b product.
33 yr 6 mo ago
interferon beta-1b: 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 interferon beta-1b.
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