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
Reference approval
Approval date of the reference marstacimab-hncq product.
4 mo ago
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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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

