GILOTRIF Drug Patent Profile

Which patents cover Gilotrif, and what generic alternatives are available?

Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-seven patent family members in forty-six countries.

The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Gilotrif

Gilotrif was eligible for patent challenges on July 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2030. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GILOTRIF

International Patents:	187
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	17
Patent Applications:	1,658
Drug Prices:	Drug price information for GILOTRIF
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILOTRIF
What excipients (inactive ingredients) are in GILOTRIF?	GILOTRIF excipients list
DailyMed Link:	GILOTRIF at DailyMed

See drug prices for GILOTRIF

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GILOTRIF

Constraining patent/regulatory exclusivity:

8,545,884*PED

NDA:

201292

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GILOTRIF

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National University Hospital, Singapore	Phase 2
National Cancer Centre, Singapore	Phase 1
Vanderbilt-Ingram Cancer Center	Phase 1

See all GILOTRIF clinical trials

Pharmacology for GILOTRIF

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for GILOTRIF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GILOTRIF	Tablets	afatinib dimaleate	20 mg, 30 mg and 40 mg	201292	7	2017-07-12

US Patents and Regulatory Information for GILOTRIF

GILOTRIF is protected by five US patents.

This potential generic entry date is based on patent 8,545,884.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No	8,545,884*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No	RE43431*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No	10,004,743*PED				Y

Expired US Patents for GILOTRIF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013	6,251,912
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013	6,251,912
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013	6,251,912

International Patents for GILOTRIF

When does loss-of-exclusivity occur for GILOTRIF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GILOTRIF around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	214798
European Patent Office	2508521	Dimaléate d'un composé crotonyl aminé et procédé pour la production (Dimaleat of an amino crotonyl compound and method of production thereof)
Japan	4594317

Supplementary Protection Certificates for GILOTRIF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	PA2014005	Lithuania		PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910	2014C/009	Belgium		PRODUCT NAME: AFATINIB ET SES TAUTOMERES, SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES, EN PARTICULIER, AFATINIB SOUS FORME DE SEL DE MALEATE OU DE DIMALEATE; AUTHORISATION NUMBER AND DATE: EU/1/13/879 20130927
1345910	1490011-2	Sweden		PRODUCT NAME: AFATINIB, TAUTOMERER, STEREOISOMERER OCH SALTER DAERAV, FYSIOLOGISKT GODTAGBARA SALTER MED OORGANISKA ELLER ORGANISKA SYROR ELLER BASER, SAERSKILT ETT MALEATSALT DAERAV, MER FOERETRAEDELSEVIS ETT DIMALEATSALT DAERAV; REG. NO/DATE: EU/1/13/879 20130925

Market Dynamics and Financial Trajectory for GILOTRIF

Last updated: February 20, 2026

What is GILOTRIF?

GILOTRIF (afatinib) is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor approved for the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. It was developed by Boehringer Ingelheim and received FDA approval in 2018. The drug targets advanced or metastatic NSCLC, primarily in patients with activating EGFR mutations such as exon 19 deletions and L858R substitutions.

Market Size and Growth Drivers

Global Lung Cancer Market Overview

The NSCLC segment accounts for approximately 85% of lung cancer cases globally. The market for targeted therapies in NSCLC was valued at USD 9 billion in 2021 and is projected to grow to USD 14 billion by 2027, at a compound annual growth rate (CAGR) of around 7%.

Key Market Segments

• NSCLC with EGFR mutations: Represents roughly 15-20% of NSCLC cases globally, estimated at 150,000 to 200,000 new cases annually in the U.S. and Europe.
• Targeted Therapy Adoption: Increasing adoption due to genetic testing, with approximately 70% of diagnosed NSCLC patients undergoing molecular profiling.

Competitive Landscape

The primary competitors include:

• Erlotinib (Tarceva) – first-generation EGFR inhibitor.
• Gefitinib (Iressa) – first-generation EGFR inhibitor.
• Osimertinib (Tagrisso) – third-generation EGFR inhibitor with central approval for first-line and subsequent treatments.
• Dacomitinib – second-generation EGFR inhibitor.

While osimertinib dominates as the first-line treatment, afatinib maintains a market share, particularly for patients intolerant to osimertinib or with specific mutation profiles.

Sales Performance and Revenue Trends

Historical Sales Data

• 2018: Launch year; initial sales estimated at USD 150 million.
• 2019: Sales grew to USD 220 million, driven by increased adoption in NSCLC patients.
• 2020: Revenue reached approximately USD 300 million; COVID-19 impacted clinic visits, but demand persisted.
• 2021: Sales increased further to approximately USD 400 million.

Geographic Breakdown

• Europe: 40%
• United States: 35%
• Asia-Pacific: 15%
• Other regions: 10%

Growth in Asia-Pacific reflects increasing NSCLC incidence and genetic testing.

Factors Influencing Market Dynamics

Regulatory Approvals and Off-Label Use

GILOTRIF has received regulatory approval in over 50 countries. Label restrictions limit use primarily to patients with documented EGFR mutations. Off-label use remains low due to limited evidence and pricing restrictions.

Patent and Intellectual Property Landscape

• The original patent protection extends until 2030 in key markets.
• Patent expirations for first-generation inhibitors occurred earlier, allowing generics, but afatinib retains patent exclusivity.

Pricing Strategies

• Average wholesale price (AWP) per treatment cycle: USD 10,000–12,000.
• Variability exists based on regional healthcare systems and reimbursement policies.

Reimbursement Policies

Coverage depends on regulatory approval and reimbursement frameworks, with some countries implementing managed entry agreements to control expenses.

Future Market and Financial Outlook

Pipeline and Next-Generation Development

No significant pipeline competitors aim to replace afatinib in its current indication, but ongoing studies explore combination therapies and new indications, which could extend its revenue potential.

Market Penetration Strategies

• Expansion into first-line settings with combination regimens.
• Broader genetic testing to identify eligible patients.
• Lifecycle management with label expansions for rare EGFR mutations.

Revenue Projections

• Expected to reach USD 600-700 million annually by 2025, driven by increased testing and expanding indications.
• Potential declines if osimertinib consolidates dominance or if generic competition emerges post-patent expiry.

Risks and Challenges

• Competition from third-generation EGFR inhibitors with better safety profiles.
• Patent expiries and generic entry in the late 2020s.
• Shifts in treatment guidelines favoring newer therapies.

Key Takeaways

• GILOTRIF holds a stable position in the EGFR-mutant NSCLC market, with steady growth driven by increased testing and diagnosis.
• Sales are expected to grow moderately, reaching USD 600-700 million by 2025.
• Competitive pressures from osimertinib and emerging therapies may challenge its market share.
• Reimbursement and regional healthcare policies significantly impact sales trajectory.
• Patent protection up to 2030 limits generic competition in the near term, but post-expiry, revenue decline is probable.

FAQs

1. How does GILOTRIF compare to osimertinib in efficacy?
GILOTRIF is effective for specific EGFR mutations but generally has a higher incidence of adverse effects and shorter progression-free survival (PFS) compared to osimertinib in first-line settings.

2. Are there ongoing trials to expand GILOTRIF’s approved indications?
Current studies are evaluating combination therapies and rare mutation subtypes, but no major label expansions are imminent.

3. What are the risks of generic competition?
Patent protection until 2030 prevents generics, but post-expiry, market share could decline rapidly unless biosimilars or generics capture significant market portions.

4. How does pricing vary across regions?
Prices are aligned with healthcare reimbursement policies; higher in the U.S. and Europe, lower in Asia-Pacific due to different pricing regulations and payer negotiations.

5. What is the outlook for GILOTRIF’s market share?
Stable in niche segments; risks arise from newer-generation drugs and potential biosimilar entry after patent expiry.

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References

[1] MarketWatch. (2022). Global NSCLC targeted therapy market size, share, growth, and forecast 2022-2027.
[2] Boehringer Ingelheim. (2018). GILOTRIF (afatinib) summary of product characteristics.
[3] EvaluatePharma. (2022). Oncology drug sales and forecasts.
[4] European Medicines Agency. (2022). Regulatory decisions on afatinib.
[5] World Health Organization. (2022). Global cancer statistics.