Purple Book reference family · 351(a) biologic
methoxy polyethylene glycol-epoetin beta (Mircera)
methoxy polyethylene glycol-epoetin beta is an FDA-licensed reference biologic from Vifor (International) Inc..
351(a) biologicBLA 125164 Vifor (International) Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2007
Reference product
Originator biologic
351(a)BLA 125164
Mircera methoxy polyethylene glycol-epoetin beta
Vifor (International) 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 methoxy polyethylene glycol-epoetin beta product.
19 yr ago
methoxy polyethylene glycol-epoetin beta: 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 methoxy polyethylene glycol-epoetin beta.
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