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

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 and four FDA Regulatory Exclusivities.

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
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No

Expired US Patents for GILOTRIF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013	6,251,912
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	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	1678165
Brazil	0116266
Japan	2004516283
Hong Kong	1060571

Supplementary Protection Certificates for GILOTRIF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	C01345910/01	Switzerland		PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
1345910	6/2014	Austria		PRODUCT NAME: AFATINIB, DEREN TAUTOMERE, DEREN STEREOISOMERE UND DEREN SALZE, PHYSIOLOGISCH VERTRAEGLICHE SALZE MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, BEVORZUGT DEREN MALEATSALZE, VORZUGSWEISE DEREN DIMALEATSALZE; REGISTRATION NO/DATE: EU/1/13/879 20130925
1345910	CR 2014 00006	Denmark		PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925
1345910	2014/009	Ireland		PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925

Market Dynamics and Financial Trajectory for GILOTRIF (Afatinib)

Last updated: July 27, 2025

Introduction

GILOTRIF, the brand name for afatinib, is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), approved primarily for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC). Since its launch, the drug has impacted oncology treatment paradigms, with market dynamics shaped by evolving clinical data, regulatory landscapes, competitive forces, and strategic company initiatives. This comprehensive analysis explores the key market drivers, challenges, financial trajectories, and outlook for GILOTRIF over the coming years.

Market Overview

Indications and Patient Population

GILOTRIF's primary indication covers first-line treatment for adult patients with metastatic non-small cell lung cancer harboring uncommon or common EGFR mutations, such as exon 19 deletions or exon 21 L858R substitutions. The global prevalence of EGFR mutations in NSCLC is estimated at approximately 10-15% in Western populations and up to 40% in Asian demographics, translating into a substantial patient pool [1].

Regulatory Approvals and Geographic Penetration

Since its initial approval by the FDA in 2018, GILOTRIF has received regulatory clearances across multiple regions, including the European Union, Japan, China, and other Asian markets. Notably, China’s regulatory authority approved afatinib in 2017, boosting its access and market share within Asia [2].

Market Dynamics

Competitive Landscape

GILOTRIF faces competition from several EGFR TKIs, each with distinct profiles:

• First-generation inhibitors—erlotinib and gefitinib—offer earlier options but are often associated with shorter progression-free survival (PFS) and resistance issues.
• Third-generation inhibitors—osimertinib—have gained dominance owing to superior efficacy, better CNS penetration, and activity against common resistance mutations like T790M.

The shift toward osimertinib as a first-line therapy following pivotal trials (e.g., FLAURA) has had a significant impact on afatinib’s market share, especially within developed markets [3].

Clinical Efficacy and Resistance

While afatinib demonstrated favorable PFS and overall response rates in clinical trials, emerging data suggesting longitudinal superiority of osimertinib restrains its adoption. Resistance mechanisms, notably the T790M mutation, further complicate afatinib’s position and necessitate sequential therapy strategies [4].

Pricing and Reimbursement Policies

Pricing strategies vary globally, with GILOTRIF’s premium pricing challenged by biosimilar and generic entries in certain markets. Reimbursement policies heavily influence market access, particularly in price-sensitive regions like China and India.

Market Penetration and Adoption

Despite its efficacy, GILOTRIF’s market penetration is mitigated by the rising preference for osimertinib. Nonetheless, GILOTRIF remains integral in regions where third-generation inhibitors are not yet affordable or approved. It is also employed as a second-line agent where resistance develops against first-generation TKIs.

Financial Trajectory

Sales Performance

Since its launch, GILOTRIF has generated substantial revenue, with peak annual sales exceeding $600 million globally in 2019 [5]. However, this is subject to decline based on:

• The adoption of osimertinib as the preferred first-line agent.
• Competitive pricing pressures.
• Patent expirations and biosimilar entries.

Forecasting Future Revenues

Market analysts project that GILOTRIF’s global sales will gradually decline over the next five years, aligning with the rising dominance of osimertinib and newer EGFR inhibitors [6]. Nevertheless, in emerging markets, where access to advanced therapies remains limited, GILOTRIF retains a significant share, offering stable revenue streams.

Impact of Patent Laws and Generics

Patent protection has been pivotal for GILOTRIF’s revenue. The expiry of key patents in major markets could facilitate generic entry, exerting downward pressure on pricing and sales volume.

Strategic Initiatives and Portfolio Diversification

The pharmaceutical company behind GILOTRIF, typically Boehringer Ingelheim, is investing in expanding indications, such as adjuvant settings and resistance management, aiming to sustain its financial trajectory. Additionally, collaborations and licensing agreements enhance its market adaptability.

Market Outlook and Strategic Considerations

Future Growth Opportunities

• Combination therapies: Combining afatinib with other agents, such as antiangiogenic drugs or immune checkpoint inhibitors, may open new therapeutic windows.
• New indications: Investigating afatinib's role in other EGFR-driven cancers, such as head and neck squamous cell carcinoma, could diversify revenue.

Challenges

• Competitive pressure from osimertinib and other emerging therapies.
• Regulatory hurdles for new indications or combination regimens.
• Pricing and reimbursement constraints, especially in cost-sensitive regions.
• Resistance mechanisms necessitating drug modifications or adjunct therapies.

Key Takeaways

• Market shifts favor third-generation EGFR inhibitors, challenging GILOTRIF’s frontline position.
• Despite declining sales prospects, GILOTRIF maintains relevance in certain geographies where newer drugs are inaccessible or unfavored.
• Patent expirations and biosimilar competition will influence GILOTRIF’s revenue trajectory over the next decade.
• Strategic diversification, including new indications and combination therapies, is crucial for sustaining its market presence.
• Region-specific market dynamics necessitate tailored commercialization strategies to capitalize on emerging opportunities.

Conclusion

GILOTRIF's market dynamics are increasingly influenced by competitive advances, evolving clinical evidence, and regional healthcare policies. While initial blockbuster success set a strong financial foundation, the drug’s future revenues hinge on strategic positioning amidst patent landscapes, emerging therapies, and regional access disparities. Companies that invest in expanding indications, improving patient outcomes, and optimizing pricing models will better navigate the complex pharmaceutical landscape surrounding GILOTRIF.

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FAQs

1. How does GILOTRIF compare to osimertinib in clinical efficacy?
Clinical trials like FLAURA demonstrate that osimertinib offers superior progression-free survival compared to earlier EGFR TKIs, including afatinib. Osimertinib's efficacy against T790M mutations and better CNS penetration give it a competitive edge. However, GILOTRIF remains relevant in specific contexts, especially where access to osimertinib is limited.

2. What regions present the most promising markets for GILOTRIF?
Emerging markets in Asia, particularly China, remain vital due to limited access to newer therapies, high prevalence of EGFR mutations, and ongoing adoption of first-generation TKIs. Latin America and parts of Eastern Europe also provide steady demand despite market saturation elsewhere.

3. What are the prospects for GILOTRIF in combination therapy?
Research into combining afatinib with immune checkpoint inhibitors or antiangiogenic agents shows potential to improve outcomes and extend its relevance. These strategies could create new revenue streams and address resistance issues.

4. When are patent expirations expected, and how will they impact sales?
Key patent expirations are anticipated between 2024 and 2026 in major markets like the US and Europe, likely leading to generic competition and significant revenue erosion unless strategic measures are undertaken.

5. Can GILOTRIF's indications expand beyond NSCLC?
Yes. Ongoing research explores its efficacy in other EGFR-driven cancers, such as head and neck squamous cell carcinoma, which could broaden its therapeutic portfolio and financial outlook.

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References

[1] Siegel, R. L., et al. (2022). Cancer Statistics. CA: A Cancer Journal for Clinicians.
[2] Chinese Food and Drug Administration (CFDA). (2017). Afatinib approval notice.
[3] Soria, J. C., et al. (2018). Osimertinib in untreated EGFR-mutated advanced NSCLC. NEJM, 378(2), 113-125.
[4] Yu, H., et al. (2019). Resistance to EGFR TKIs. Nature Reviews Clinical Oncology, 16(10), 637–653.
[5] Company earnings reports (2019). Boehringer Ingelheim Annual Financial Report.
[6] MarketWatch. (2022). Oncology drug market forecasts.

[Note: Actual sales figures, patent expiry dates, and clinical trial outcomes should be sourced from the most recent and authoritative industry reports for precise strategic planning.]