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FDA Purple Book · Reference family

mosunetuzumab-axgb (Lunsumio)

mosunetuzumab-axgb is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2022

Reference approved

Reference product

351(a)BLA 761263

Lunsumio mosunetuzumab-axgb

Genentech, Inc.

Approved
Dec 22, 2022
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for mosunetuzumab-axgb, in chronological order.

  1. Reference approval

    Approval date of the reference mosunetuzumab-axgb product.

    3 yr 6 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 3 yr 7 mo

Frequently asked questions

Are there biosimilars approved for mosunetuzumab-axgb (Lunsumio)?

No 351(k) biosimilars or interchangeable biosimilars referencing mosunetuzumab-axgb are listed in the FDA Purple Book yet.

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