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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 five 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:	48
Clinical Trials:	17
Patent Applications:	476
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

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 and four FDA Regulatory Exclusivities.

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					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

Expired US Patents for GILOTRIF

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

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
Norway	20032726
Spain	2588031
Peru	20100252	NUEVAS FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN DIMALEATO DE 4-[(3-CLORO-4-FLUOROFENIL) AMINO]-6-{[4-(N,N-DIMETILAMINO)-1-OXO-2-BUTEN-1-IL] AMINO}-7-((S)-TETRAHIDROFURAN-3-ILOXI)-QUINAZOLINA

Supplementary Protection Certificates for GILOTRIF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	SPC/GB14/015	United Kingdom		PRODUCT NAME: AFATINIB, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, IN PARTICULAR A SALT WITH MALEIC ACID; REGISTERED: UK EU/1/13/879/001 20130927; UK EU/1/13/879/002 20130927; UK EU/1/13/879/003 20130927; UK EU/1/13/879/004 20130927; UK EU/1/13/879/005 20130927; UK EU/1/13/879/006 20130927; UK EU/1/13/879/007 20130927; UK EU/1/13/879/008 20130927; UK EU/1/13/879/009 20130927; UK EU/1/13/879/010 20130927; UK EU/1/13/879/011 20130927; UK EU/1/13/879/012 20130927
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	PA2014005	Lithuania		PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925

GILOTRIF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GILOTRIF (Afatinib)

Introduction to GILOTRIF (Afatinib)

GILOTRIF, also known as afatinib, is a targeted therapy used primarily in the treatment of non-small cell lung cancer (NSCLC) with specific epidermal growth factor receptor (EGFR) mutations. Developed by Boehringer Ingelheim, afatinib has been a significant player in the oncology market.

Market Size and Growth

The global afatinib market has been experiencing robust growth. As of 2022, the market size was valued at USD 692.6 million. It is projected to reach USD 3934.22 million by 2032, exhibiting a compound annual growth rate (CAGR) of 18.97% during the period from 2024 to 2032[1].

Driving Factors

Several factors are driving the growth of the afatinib market:

Advancements in Cancer Research

Continuous advancements in cancer research have expanded the potential applications of afatinib, making it a more viable treatment option for various cancer indications[1].

Increasing Incidence of Cancer

The rising incidence of cancer, particularly NSCLC, has significantly influenced the demand for targeted therapies like afatinib. This trend is expected to continue, driving market growth[1].

Regulatory Approvals and Clinical Trials

Regulatory approvals and ongoing clinical trials are crucial for the market dynamics of afatinib. New indications and combination therapies are being explored, which will further expand the market[3].

Key Players

The afatinib market is dominated by several key players:

Boehringer Ingelheim

As the developer of GILOTRIF, Boehringer Ingelheim is a major player in the market. The company continues to invest in research and development to enhance the drug's efficacy and expand its indications[1].

Other Competitors

Other companies such as Hengrui Medicine and Beacon Pharma are also significant players in the afatinib market, contributing to the competitive landscape[1].

Financial Performance

The financial performance of afatinib is closely tied to the overall oncology market trends.

Revenue Projections

The projected revenue growth from USD 692.6 million in 2022 to USD 3934.22 million by 2032 indicates a strong financial trajectory for afatinib. This growth is driven by increased sales and expanding market share[1].

Comparison with Other Oncology Markets

In comparison, other oncology markets, such as the EGFR inhibitor market, are also experiencing significant growth. The EGFR inhibitor market, for instance, is expected to grow substantially due to increasing incidence, rising awareness, and robust pipeline activity[3].

Competitive Landscape

The competitive landscape of the afatinib market is dynamic and competitive.

Established Drugs

Established drugs like gefitinib and erlotinib have long been staples in treatment protocols. However, newer entrants like osimertinib have changed market dynamics, leading to shifts in prescribing patterns and market dominance[3].

New Entrants and Biosimilars

Newer EGFR inhibitors such as petosemtamab, MCLA-129, and zipalertinib are entering the market, offering alternative treatment options. The emergence of biosimilars and generics adds another layer of complexity, driving down prices and intensifying competition[3].

Regulatory and Market Dynamics

Regulatory developments and evolving treatment paradigms play a crucial role in the market dynamics of afatinib.

Precision Medicine

Advances in precision medicine, where treatment decisions are tailored to a patient's genetic profile, continue to shape the market. Regulatory agencies' role in approving new indications and ensuring drug safety will influence the market's trajectory[3].

Clinical Trials and Combination Therapies

Ongoing clinical trials exploring combination therapies and new indications promise to expand the market further. For example, trials assessing MCLA-129 combined with chemotherapy for second-line and beyond NSCLC treatment are underway[3].

Financial Support and Access

To enhance patient access, financial support programs are available for patients prescribed GILOTRIF.

Patient Assistance Programs

Boehringer Ingelheim offers financial support programs for patients, including income and prescription coverage criteria, to help make the drug more accessible[5].

Key Takeaways

• The global afatinib market is expected to grow significantly, reaching USD 3934.22 million by 2032 with a CAGR of 18.97%.
• Advancements in cancer research and increasing cancer incidence are key drivers.
• Boehringer Ingelheim and other companies are major players in the market.
• The competitive landscape is influenced by new entrants, biosimilars, and regulatory developments.
• Financial support programs are available to enhance patient access.

FAQs

What is the expected market size of afatinib by 2032?

The global afatinib market is expected to reach USD 3934.22 million by 2032[1].

What is the CAGR of the afatinib market from 2024 to 2032?

The afatinib market is expected to exhibit a CAGR of 18.97% from 2024 to 2032[1].

Which companies are the top players in the afatinib market?

Boehringer Ingelheim, Hengrui Medicine, and Beacon Pharma are the top companies operating in the afatinib market[1].

What are the key factors driving the growth of the afatinib market?

Advancements in cancer research and the growing incidence of cancer are significantly influencing the market growth[1].

Are there financial support programs available for patients prescribed GILOTRIF?

Yes, Boehringer Ingelheim offers financial support programs for patients prescribed GILOTRIF, including income and prescription coverage criteria[5].

Sources

1. Business Research Insights: Afatinib Market 2024 To 2032 | [108] Pages Report
2. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results
3. GlobeNewswire: EGFR Inhibitor Market to Accelerate Substantially During the Study Period (2020–2034) - DelveInsight's Analysis
4. Cognitive Market Research: Afatinib Market Report 2024 (Global Edition)
5. Boehringer Ingelheim: Financial Support | GILOTRIF® (afatinib) tablets