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BLA

BENRALIZUMAB | B761070 | ASTRAZENECA AB

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 14, 2029(1230 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 14, 2029	Active	Computed
7-Year Orphan	Sep. 17, 1931	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 8, 20456884 days remaining

Based on latest discovered patent 12297501(diagnostic) · relevance 70/100

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

Discovered Patents

View all 29 patents →

29 AI-discovered patents, sorted by relevance.

Composition

(13)

96/10012173075Grant: 2024-12-24 | Exp: 2044-12-19

65/1008067564Grant: 2011-11-29 | Exp: 2031-11-24

65/1008008443Grant: 2011-08-30 | Exp: 2031-08-25

55/1007393648Grant: 2008-07-01 | Exp: 2028-06-26

55/1009919056Grant: 2018-03-20 | Exp: 2038-03-15

50/1007482435Grant: 2009-01-27 | Exp: 2029-01-22

50/1009242013Grant: 2016-01-26 | Exp: 2036-01-21

50/1009371378Grant: 2016-06-21 | Exp: 2036-06-16

50/10011912782Grant: 2024-02-27 | Exp: 2044-02-22

50/1009968687Grant: 2018-05-15 | Exp: 2038-05-10

50/10012178876Grant: 2024-12-31 | Exp: 2044-12-26

50/1009527927Grant: 2016-12-27 | Exp: 2036-12-22

50/10010744204Grant: 2020-08-18 | Exp: 2040-08-13

Formulation

(1)

50/1008754195Grant: 2014-06-17 | Exp: 2034-06-12

Method of Use

(3)

95/1009441046Grant: 2016-09-13 | Exp: 2036-09-08

95/1009441047Grant: 2016-09-13 | Exp: 2036-09-08

95/1009441037Grant: 2016-09-13 | Exp: 2036-09-08

Manufacturing

(9)

55/1009068198Grant: 2015-06-30 | Exp: 2035-06-25

55/10010259842Grant: 2019-04-16 | Exp: 2039-04-11

50/1007635666Grant: 2009-12-22 | Exp: 2029-12-17

50/1007723270Grant: 2010-05-25 | Exp: 2030-05-20

50/1006492160Grant: 2002-12-10 | Exp: 2022-12-05

50/1007662557Grant: 2010-02-16 | Exp: 2030-02-11

50/10010556955Grant: 2020-02-11 | Exp: 2040-02-06

50/10010618952Grant: 2020-04-14 | Exp: 2040-04-09

50/1006172197Grant: 2001-01-09 | Exp: 2021-01-04

Device

(1)

50/10011482315Grant: 2022-10-25 | Exp: 2042-10-20

Diagnostic

(2)

82/1008961965Grant: 2015-02-24 | Exp: 2035-02-19

70/10012297501Grant: 2025-05-13 | Exp: 2045-05-08

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 761070 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

benralizumab

Applicant

AstraZeneca AB

Approval Date

14-Nov-17

Orphan Exclusivity

17-Sep-31

Expired

Presentations

30MG/ML — Pre-Filled Syringe (Subcutaneous)

30MG/ML — Autoinjector (Subcutaneous)

10MG/0.5ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2026	SUPPL -23	View Letter (PDF)
Sep 19, 2024	SUPPL -21	View Letter (PDF)
Apr 8, 2024	SUPPL -20	View Letter (PDF)
Oct 4, 2019	SUPPL -5	View Letter (PDF)
Nov 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG/ML

▴

INJECTABLE;INJECTION | Approved: 2017-11-14 00:00:00

No patent or exclusivity listings for this strength.