Gilotrif

(Afatinib Dimaleate)

ApprovedSmall molecule

Boehringer Ingelheim

Gilotrif is one of 53 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerUnknown status

Advanced LymphomaActive, not recruiting

Non-Small Cell Lung CancerApproved

Unknown status

Advanced LymphomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Gilotrif

Boehringer Ingelheim

Approved

3 2

Carboplatin Plus Paclitaxel

Bayer

Phase 3

2 3

HB1801

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 3

2 4

HLX17

Shanghai Henlius Biotech

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Active, not recruiting

Non-Small Cell Lung Cancer

NCT02438722

Q1 2027

Phase 2Active, not recruiting

Advanced Lymphoma

NCT04439136

Q4 2027

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion

Unknown status·SShanghai Chest Hospital·Phase 4·NCT04814056·15 enrolled

S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer

Active, not recruiting·SSWOG Cancer Research Network·Phase 2/3·NCT02438722·174 enrolled

Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib

Completed·JJonathan Riess·Phase 1·NCT02364609·11 enrolled

Advanced Lymphoma2 trials

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients With Tumors With HER2 Activating Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439136·40 enrolled

Urothelial Cancer1 trial

Afatinib in Advanced Refractory Urothelial Cancer

Terminated·UUniversity of Chicago·Phase 2·NCT02122172·32 enrolled

Pancreatic Cancer1 trial

Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer

Completed·UUniversity of Washington·Phase 1·NCT02451553·41 enrolled

Unspecified1 trial

Long-term Observation PMS for Afatinib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02131259·1,605 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 12, 2013

GILOTRIF

NDA NDA201292

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Afatinib Dimaleate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Afatinib Dimaleate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Afatinib Dimaleate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA201292). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gilotrif. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Patent Landscape[5]

Patent Cliff

Nov 9, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE43431Jan 13, 2026

RE43431*PEDJul 13, 2026

9539258Nov 9, 2026

9539258*PEDMay 9, 2027

8426586Oct 10, 2029

5 more patents

8545884Dec 19, 2029

8426586*PEDApr 10, 2030

8545884*PEDJun 19, 2030

10004743Jul 5, 2030

10004743*PEDJan 5, 2031

Gilotrif

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Advanced Lymphoma2 trials

Urothelial Cancer1 trial

Pancreatic Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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