methoxy polyethylene glycol-epoetin beta (Mircera)
methoxy polyethylene glycol-epoetin beta is an FDA-licensed reference biologic from Vifor (International) Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2007
Reference approved
Reference product
Mircera methoxy polyethylene glycol-epoetin beta
Vifor (International) Inc.
- Approved
- Nov 14, 2007
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for methoxy polyethylene glycol-epoetin beta, in chronological order.
Reference approval
Approval date of the reference methoxy polyethylene glycol-epoetin beta product.
18 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for methoxy polyethylene glycol-epoetin beta (Mircera)?
No 351(k) biosimilars or interchangeable biosimilars referencing methoxy polyethylene glycol-epoetin beta are listed in the FDA Purple Book yet.
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