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Purple Book reference family · 351(a) biologic

marstacimab-hncq (Hympavzi)

marstacimab-hncq is an FDA-licensed reference biologic from Pfizer Inc..

351(a) biologicBLA 761369 Pfizer Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026

Reference product

Originator biologic
351(a)BLA 761369

Hympavzi marstacimab-hncq

Pfizer Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference marstacimab-hncq product.

    4 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 5 yr 1 mo

marstacimab-hncq: 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 marstacimab-hncq.

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