Purple Book reference family · 351(a) biologic
peginterferon alfa-2b and ribavirin (PegIntron/ Rebetol Combo Pack)
peginterferon alfa-2b and ribavirin is an FDA-licensed reference biologic from Schering Corporation a subsidiary of Merck & Co., Inc..
351(a) biologicBLA 125196 Schering Corporation a subsidiary of Merck & Co., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2008
Reference product
Originator biologic
351(a)BLA 125196
PegIntron/ Rebetol Combo Pack peginterferon alfa-2b and ribavirin
Schering Corporation a subsidiary of Merck & Co., Inc.
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 and ribavirin product.
18 yr 5 mo ago
peginterferon alfa-2b and ribavirin: 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 and ribavirin.
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