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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2008
Reference approved
Reference product
PegIntron/ Rebetol Combo Pack peginterferon alfa-2b and ribavirin
Schering Corporation a subsidiary of Merck & Co., Inc.
- Approved
- Jun 13, 2008
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for peginterferon alfa-2b and ribavirin, in chronological order.
Reference approval
Approval date of the reference peginterferon alfa-2b and ribavirin product.
18 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for peginterferon alfa-2b and ribavirin (PegIntron/ Rebetol Combo Pack)?
No 351(k) biosimilars or interchangeable biosimilars referencing peginterferon alfa-2b and ribavirin are listed in the FDA Purple Book yet.
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