Viewing data from:

ERELZI

Biosimilar

ETANERCEPT-SZZS | B761042 | SANDOZ

2 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

August 30, 2028(789 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 30, 2028	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 3, 20456849 days remaining

Based on latest discovered patent 12269843(manufacturing) · relevance 70/100

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

Approved Biosimilars

ErelziBLA 761042ErelziBLA 761042Erelzi SensoreadyBLA 761042ErelziBLA 761042

Discovered Patents

View all 118 patents →

Top 50 of 118 AI-discovered patents by relevance.

Composition

(29)

95/1006221675Grant: 2001-04-24 | Exp: 2021-04-19

95/1006417158Grant: 2002-07-09 | Exp: 2022-07-04

95/1007264944Grant: 2007-09-04 | Exp: 2027-08-30

92/1007282483Grant: 2007-10-16 | Exp: 2027-10-11

92/1006271346Grant: 2001-08-07 | Exp: 2021-08-02

88/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

85/1009182410Grant: 2015-11-10 | Exp: 2035-11-05

85/1006627199Grant: 2003-09-30 | Exp: 2023-09-25

78/1007166707Grant: 2007-01-23 | Exp: 2027-01-18

75/1007189827Grant: 2007-03-13 | Exp: 2027-03-08

75/10010961297Grant: 2021-03-30 | Exp: 2041-03-25

75/1007186810Grant: 2007-03-06 | Exp: 2027-03-01

75/1007737111Grant: 2010-06-15 | Exp: 2030-06-10

75/1007029871Grant: 2006-04-18 | Exp: 2026-04-13

72/1007842784Grant: 2010-11-30 | Exp: 2030-11-25

72/1006660843Grant: 2003-12-09 | Exp: 2023-12-04

72/1006838550Grant: 2005-01-04 | Exp: 2024-12-30

70/1007112659Grant: 2006-09-26 | Exp: 2026-09-21

70/1007169905Grant: 2007-01-30 | Exp: 2027-01-25

70/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

70/1007956038Grant: 2011-06-07 | Exp: 2031-06-02

68/1008143380Grant: 2012-03-27 | Exp: 2032-03-22

65/1009200040Grant: 2015-12-01 | Exp: 2035-11-26

65/1007482325Grant: 2009-01-27 | Exp: 2029-01-22

65/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

65/1009421245Grant: 2016-08-23 | Exp: 2036-08-18

65/1008999917Grant: 2015-04-07 | Exp: 2035-04-02

65/1006774106Grant: 2004-08-10 | Exp: 2024-08-05

65/1009200060Grant: 2015-12-01 | Exp: 2035-11-26

Formulation

(7)

88/1009453067Grant: 2016-09-27 | Exp: 2036-09-22

75/10010166189Grant: 2019-01-01 | Exp: 2038-12-27

70/1009283260Grant: 2016-03-15 | Exp: 2036-03-10

65/1007906109Grant: 2011-03-15 | Exp: 2031-03-10

65/1007956160Grant: 2011-06-07 | Exp: 2031-06-02

65/10010188600Grant: 2019-01-29 | Exp: 2039-01-24

65/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

Method of Use

(2)

68/1007379820Grant: 2008-05-27 | Exp: 2028-05-22

65/1006790823Grant: 2004-09-14 | Exp: 2024-09-09

Manufacturing

(12)

95/1007238776Grant: 2007-07-03 | Exp: 2027-06-28

92/10011952399Grant: 2024-04-09 | Exp: 2044-04-04

86/1009598718Grant: 2017-03-21 | Exp: 2037-03-16

72/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

72/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

70/10012269843Grant: 2025-04-08 | Exp: 2045-04-03

70/1008058407Grant: 2011-11-15 | Exp: 2031-11-10

68/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

65/10011130980Grant: 2021-09-28 | Exp: 2041-09-23

65/10011254963Grant: 2022-02-22 | Exp: 2042-02-17

60/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

60/1008173394Grant: 2012-05-08 | Exp: 2032-05-03

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 761042 | 4 presentations

BiosimilarLicensedCDERInjection

Proper Name

etanercept-szzs

Applicant

Sandoz Inc.

Approval Date

30-Aug-16

Reference Product: Enbrel — etanercept

Presentations

25MG/0.5ML — Pre-Filled Syringe (Subcutaneous)

50MG/ML — Pre-Filled Syringe (Subcutaneous)

50MG/ML — Autoinjector (Subcutaneous)

25MG — Multi-Dose Vial (Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 14, 2022	SUPPL -18	View Letter (PDF)
Jun 12, 2020	SUPPL -12	View Letter (PDF)
Oct 22, 2019	SUPPL -10	View Letter (PDF)
Jan 30, 2018	SUPPL -1	View Letter (PDF)
Aug 30, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG/0.5ML

▴

INJECTABLE; INJECTION | Approved: 2016-08-30 00:00:00

No patent or exclusivity listings for this strength.

#002 — 50MG/ML

▾

INJECTABLE; INJECTION | Approved: 2016-08-30 00:00:00