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BLA

ANSUVIMAB-ZYKL | B761172 | RIDGEBACK BIOTHERAPEUTICS

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 21, 2032(2363 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 21, 2032	Active	Computed
7-Year Orphan	Dec. 21, 2027	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 26, 20446660 days remaining

Based on latest discovered patent 12102677(method of use) · relevance 55/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 21 patents →

21 AI-discovered patents, sorted by relevance.

Composition

(14)

70/1006962702Grant: 2005-11-08 | Exp: 2025-11-03

65/10010882898Grant: 2021-01-05 | Exp: 2040-12-31

55/1008236319Grant: 2012-08-07 | Exp: 2032-08-02

55/1009458244Grant: 2016-10-04 | Exp: 2036-09-29

55/1006458933Grant: 2002-10-01 | Exp: 2022-09-26

55/1006953675Grant: 2005-10-11 | Exp: 2025-10-06

55/1006472511Grant: 2002-10-29 | Exp: 2022-10-24

52/1008889669Grant: 2014-11-18 | Exp: 2034-11-13

52/1009592293Grant: 2017-03-14 | Exp: 2037-03-09

50/1006254868Grant: 2001-07-03 | Exp: 2021-06-28

50/1008877194Grant: 2014-11-04 | Exp: 2034-10-30

50/1007074405Grant: 2006-07-11 | Exp: 2026-07-06

50/1008680246Grant: 2014-03-25 | Exp: 2034-03-20

50/1009872922Grant: 2018-01-23 | Exp: 2038-01-18

Formulation

(1)

60/1009707300Grant: 2017-07-18 | Exp: 2037-07-13

Method of Use

(2)

55/10012102677Grant: 2024-10-01 | Exp: 2044-09-26

55/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

Manufacturing

(4)

68/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

65/1008633139Grant: 2014-01-21 | Exp: 2034-01-16

50/10011833214Grant: 2023-12-05 | Exp: 2043-11-30

50/1009266950Grant: 2016-02-23 | Exp: 2036-02-18

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761172

351(a) ReferenceLicensedCDERFor Injection

Proper Name

ansuvimab-zykl

Applicant

Emergent Manufacturing Operations Baltimore LLC

Approval Date

21-Dec-20

Orphan Exclusivity

21-Dec-27

1y 5mo remaining

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 19, 2026	SUPPL -11	View Letter (PDF)
Dec 27, 2024	SUPPL -8	View Letter (PDF)
May 20, 2022	SUPPL -4	View Letter (PDF)
Dec 28, 2021	SUPPL -2	View Letter (PDF)
Dec 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG/VIAL

▴

POWDER;IV (INFUSION) | Approved: 2020-12-21 00:00:00

No patent or exclusivity listings for this strength.