Wednesday, July 8, 2026

Drug profile · INN

etanercept

etanercept (BRENZYS) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AB01
US status approved
Patents linked 20
Pipeline programs 20
News articles 1
Drug details — etanercept
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
SUBCUTANEOUS
Patents
20
Programs
20
Data quality
0.84

Quick answer

etanercept (BRENZYS) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN etanercept
Brand BRENZYS
Mechanism TNF-alpha inhibitor
Target Tumor necrosis factor
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route SUBCUTANEOUS
Formulation VIAL
ATC code L04AB01

Mechanism of action

TNF-alpha inhibitor

Primary target: Tumor necrosis factor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. Enbrel solution for injection in pre-filled s... for Chronic Plaque Psoriasis Phase 3 · Janssen-Cilag International N.V · Chronic Plaque Psoriasis
  2. Etanercept Phase 3 · Sunshine Guojian Pharmaceutical · Rheumatoid Arthritis
  3. Etanercept Phase 3 · Coherus Oncology · Rheumatoid Arthritis
  4. Etanercept Phase 3 · Coherus Oncology · Plaque Psoriasis
  5. MB04-C-01-23 Phase 3 · mAbxience · Rheumatoid Arthritis
  6. SMART-JIA Phase 3 · George Institute for · Juvenile Idiopathic Arthritis
  7. TILD-19-12 Phase 3 · Anaxis Pharma · Treatment of pediatric subjects with moderate to severe chro
  8. The STARS trial Phase 3 · George Institute for · juvenile idiopathic arthritis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. adalimumab-aqvh TNF-alpha inhibitor
  3. anagrelide Antineoplastic and immunomodulating agents (L01)
  4. apremilast Antineoplastic and immunomodulating agents (L04)
  5. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  6. axitinib Antineoplastic and immunomodulating agents (L01)
  1. US 11419812

    Methods for delivering etanercept preparations into a lumen of the intestinal tract using a swallowable drug delivery device

    Expires Mon Aug 18 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11135267

    Etanercept formulations stabilized with metal ions

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11129876

    Etanercept formulations stabilized with amino acids

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11001627

    Correctly folded etanercept in high purity and excellent yield

    Expires Mon May 06 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11000588

    Etanercept formulations stabilized with sodium chloride

    Expires Mon May 06 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 10987405

    Method of reducing formation of etanercept aggregates or fragments

    Expires Mon Apr 22 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 10980885

    Method of reducing formation of etanercept aggregates or fragments

    Expires Mon Apr 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 10980884

    Stable aqueous etanercept composition

    Expires Mon Apr 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10975138

    Correctly folded etanercept composition

    Expires Mon Apr 08 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10954293

    Correctly folded etanercept in high purity and excellent yield

    Expires Mon Mar 18 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10954294

    Correctly folded etanercept in high purity and excellent yield

    Expires Mon Mar 18 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10954295

    Correctly folded etanercept in high purity and excellent yield

    Expires Mon Mar 18 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10947306

    Correctly folded etanercept in high purity and excellent yield

    Expires Mon Mar 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10888619

    Stable aqueous etanercept composition

    Expires Mon Jan 07 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10822429

    Etanercept formulations exhibiting marked reduction in sub-visible particles

    Expires Mon Oct 29 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10772963

    Etanercept formulations stabilized with xylitol

    Expires Mon Sep 10 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10639272

    Methods for delivering etanercept preparations into a lumen of the intestinal tract using a swallowable drug delivery device

    Expires Mon Apr 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10493151

    Etanercept formulations stabilized with sodium chloride

    Expires Mon Nov 28 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 10485869

    Etanercept formulations stabilized with meglumine

    Expires Mon Nov 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 10376588

    Etanercept formulations stabilized with combinations of sugars and polyols

    Expires Mon Aug 08 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is etanercept?

etanercept (BRENZYS) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for etanercept?

BRENZYS is a marketed brand name for etanercept. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of etanercept?

etanercept has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.