peginterferon alfa-2b (Pegintron)
peginterferon alfa-2b is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2001
Reference approved
Reference product
Pegintron peginterferon alfa-2b
Merck Sharp & Dohme LLC
- Approved
- Jan 19, 2001
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for peginterferon alfa-2b, in chronological order.
Reference approval
Approval date of the reference peginterferon alfa-2b product.
25 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for peginterferon alfa-2b (Pegintron)?
No 351(k) biosimilars or interchangeable biosimilars referencing peginterferon alfa-2b are listed in the FDA Purple Book yet.
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