Purple Book reference family · 351(a) biologic
peginterferon alfa-2a and ribavirin (Pegasys Copegus Combination Pack)
peginterferon alfa-2a and ribavirin is an FDA-licensed reference biologic from Hoffmann-La Roche Inc..
351(a) biologicBLA 125083 Hoffmann-La Roche Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2004
Reference product
Originator biologic
351(a)BLA 125083
Pegasys Copegus Combination Pack peginterferon alfa-2a and ribavirin
Hoffmann-La Roche 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-2a and ribavirin product.
22 yr 6 mo ago
peginterferon alfa-2a 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-2a and ribavirin.
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