Viewing data from:

CINQAIR

BLA

RESLIZUMAB | B761033 | TEVA RESPIRATORY LLC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 23, 2028(629 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 23, 2028	Active	Computed

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 24 patents →

24 AI-discovered patents, sorted by relevance.

Composition

(13)

80/10012059457Grant: 2024-08-13 | Exp: 2044-08-08

75/1009505826Grant: 2016-11-29 | Exp: 2036-11-24

72/1009447181Grant: 2016-09-20 | Exp: 2036-09-15

72/1009592293Grant: 2017-03-14 | Exp: 2037-03-09

60/1007501120Grant: 2009-03-10 | Exp: 2029-03-05

55/1009872922Grant: 2018-01-23 | Exp: 2038-01-18

55/10010040852Grant: 2018-08-07 | Exp: 2038-08-02

55/1009944720Grant: 2018-04-17 | Exp: 2038-04-12

52/1008901279Grant: 2014-12-02 | Exp: 2034-11-27

50/10010792372Grant: 2020-10-06 | Exp: 2040-10-01

50/1009855343Grant: 2018-01-02 | Exp: 2037-12-28

50/10011033634Grant: 2021-06-15 | Exp: 2041-06-10

50/10011572349Grant: 2023-02-07 | Exp: 2043-02-02

Method of Use

(2)

65/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

50/1009175075Grant: 2015-11-03 | Exp: 2035-10-29

Manufacturing

(6)

75/10010053720Grant: 2018-08-21 | Exp: 2038-08-16

65/10010494348Grant: 2019-12-03 | Exp: 2039-11-28

65/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

58/1008895709Grant: 2014-11-25 | Exp: 2034-11-20

55/1009975948Grant: 2018-05-22 | Exp: 2038-05-17

50/10011426706Grant: 2022-08-30 | Exp: 2042-08-25

Diagnostic

(3)

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

58/1006379890Grant: 2002-04-30 | Exp: 2022-04-25

55/1009170262Grant: 2015-10-27 | Exp: 2035-10-22

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 761033

351(a) ReferenceLicensedCDERInjection

Proper Name

reslizumab

Applicant

Teva Respiratory, LLC

Approval Date

23-Mar-16

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 18, 2019	SUPPL -10	View Letter (PDF)
Mar 29, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/10ML

▴

INJECTABLE;INJECTION | Approved: 2016-03-23 00:00:00

No patent or exclusivity listings for this strength.