Purple Book reference family · 351(a) biologic
peginterferon alfa-2b (Pegintron)
peginterferon alfa-2b is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 103949 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2001
Reference product
Originator biologic
351(a)BLA 103949
Pegintron peginterferon alfa-2b
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference peginterferon alfa-2b product.
25 yr 11 mo ago
peginterferon alfa-2b: 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 peginterferon alfa-2b.
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