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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
Pegasys Copegus Combination Pack peginterferon alfa-2a and ribavirin
Hoffmann-La Roche Inc.
- Approved
- Jun 04, 2004
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for peginterferon alfa-2a and ribavirin, in chronological order.
Reference approval
Approval date of the reference peginterferon alfa-2a and ribavirin product.
22 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for peginterferon alfa-2a and ribavirin (Pegasys Copegus Combination Pack)?
No 351(k) biosimilars or interchangeable biosimilars referencing peginterferon alfa-2a and ribavirin are listed in the FDA Purple Book yet.
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