Afatinib dimaleate - Generic Drug Details

What are the generic sources for afatinib dimaleate and what is the scope of freedom to operate?

Afatinib dimaleate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Afatinib dimaleate has one hundred and eighty-seven patent family members in forty-six countries.

There are six drug master file entries for afatinib dimaleate. One supplier is listed for this compound.

Summary for afatinib dimaleate

International Patents:	187
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	9
Patent Applications:	1,394
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for afatinib dimaleate
DailyMed Link:	afatinib dimaleate at DailyMed

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

Constraining patent/regulatory exclusivity:

8,545,884*PED

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 afatinib dimaleate

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

Sponsor	Phase
Shanghai Chest Hospital	Phase 4
University of Washington	Phase 1
University of California, Davis	Phase 1

See all afatinib dimaleate clinical trials

Pharmacology for afatinib dimaleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for afatinib dimaleate

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AFATINIB DIMALEATE

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 afatinib dimaleate

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	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	9,539,258*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No

Expired US Patents for afatinib dimaleate

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 afatinib dimaleate

Country	Patent Number	Title	Estimated Expiration
Argentina	072062	FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN BIBW 2992
South Korea	20110025908	SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992
Mexico	PA06004076	PROCESO PARA LA PREPARACION DE COMPUESTOS DE AMINOCROTONILO. (METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS.)
Taiwan	200526644	Process for preparing amino crotonyl compounds

Supplementary Protection Certificates for afatinib dimaleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1345910	14C0009	France		PRODUCT NAME: AFATINIB,SES TAUTOMERES,SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES,EN PARTICULIER LE MALEATE OU LE DIMALEATE.; REGISTRATION NO/DATE: EU/1/13/879 20130925
1345910	CA 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	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

Market Dynamics and Financial Trajectory of Afatinib Dimaleate

Introduction to Afatinib Dimaleate

Afatinib dimaleate, known by its trade name Gilotrif, is a potent dual specificity inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2). It is primarily used in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations.

Market Size and Growth

The global Afatinib dimaleate market has been experiencing significant growth. As of 2023, the market size was valued at several billion USD and is anticipated to grow at a compound annual growth rate (CAGR) of a notable percentage from 2024 to 2031[4].

Key Market Drivers

Several factors are driving the growth of the Afatinib dimaleate market:

Increasing Incidence of NSCLC

The rising incidence of NSCLC, particularly among patients with EGFR mutations, is a major driver. Afatinib dimaleate's efficacy in treating these mutations makes it a preferred choice for first-line treatment[2].

Clinical Efficacy

Afatinib dimaleate has demonstrated superior progression-free survival compared to other tyrosine kinase inhibitors like gefitinib and standard chemotherapy. This clinical efficacy enhances its market appeal[2].

Regulatory Approvals

Regulatory approvals in various regions have expanded the market reach of Afatinib dimaleate. Continuous approvals and recommendations from health authorities contribute to its growing demand[5].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

High Treatment Costs

The high cost of Afatinib dimaleate is a significant barrier, especially in regions with limited healthcare budgets. This can limit accessibility and impact market growth[2].

Side Effects and Adverse Reactions

Afatinib dimaleate can cause severe side effects, including diarrhea, rash, and stomatitis. Managing these adverse reactions adds to the overall treatment cost and can deter some patients[2].

Competitive Landscape

The Afatinib dimaleate market is competitive, with several key players:

• Boehringer Ingelheim Pharmaceuticals: The primary manufacturer and marketer of Afatinib dimaleate.
• APExBIO Technology LLC, Carbosynth Ltd, Biorbyt, and others: These companies supply Afatinib dimaleate for research and clinical use[1].

Regional Analysis

The global market for Afatinib dimaleate is segmented across various regions, with different growth trajectories:

North America

This region is expected to dominate the market due to high healthcare spending, advanced healthcare infrastructure, and a large patient population with NSCLC[3].

Europe and Asia-Pacific

These regions are also significant markets, driven by increasing healthcare expenditures and a growing awareness of targeted therapies for NSCLC[3].

Financial Trajectory

Budget Impact Analysis

A study on the budget impact of increasing Afatinib dimaleate treatment share in a health plan over a 5-year period showed that while the treatment share increased by 5 percentage points annually, the total budget impact was relatively small. The estimated budget increases ranged from $1,606 in the first year to $303,368 in the fifth year, translating to a per-member-per-month increase of $0.00 to $0.03[2].

Revenue Forecast

The market revenue for Afatinib dimaleate is expected to grow significantly from 2024 to 2031, driven by increasing demand and expanding treatment options. The forecasted data indicates a substantial increase in market value, reflecting the drug's clinical efficacy and market acceptance[4].

Clinical Outcomes and Cost-Effectiveness

Progression-Free Survival

Afatinib dimaleate has been shown to increase the proportion of patients remaining in progression-free disease. A study indicated that with a 5-percentage-point annual increase in Afatinib dimaleate treatment share, the proportion of treated patients in progression-free disease increased from 23.7% to 26.2% by the end of the fifth year[2].

Cost-Effectiveness

Despite the higher costs associated with Afatinib dimaleate, its cost-effectiveness is supported by its ability to extend progression-free survival and improve patient outcomes. The small budget impact on health plans further underscores its cost-effectiveness[2].

Scenario Analyses and Sensitivity Testing

Scenario analyses were conducted to assess different treatment share assumptions. These included less aggressive and more aggressive uptake scenarios, as well as scenarios where the increase in Afatinib dimaleate share came solely from a reduction in erlotinib treatment share. One-way sensitivity analyses were also performed to test the robustness of the model against parameter uncertainty[2].

Market Trends and Opportunities

Personalized Medicine

The trend towards personalized medicine, where treatments are tailored to specific genetic mutations, is a significant opportunity for Afatinib dimaleate. Its efficacy in treating EGFR mutation-positive NSCLC aligns well with this trend[5].

Expanding Indications

There is potential for Afatinib dimaleate to be approved for additional indications, further expanding its market reach. Ongoing clinical trials and research are crucial in this regard[5].

Challenges and Restraints

Patent Expirations

The expiration of patents for Afatinib dimaleate could lead to the entry of generic competitors, potentially impacting the market share of the original manufacturer[3].

Regulatory Changes

Changes in regulatory policies or reimbursement criteria can affect the market dynamics and financial trajectory of Afatinib dimaleate[3].

Conclusion

The market for Afatinib dimaleate is poised for significant growth driven by its clinical efficacy, increasing incidence of NSCLC, and expanding treatment options. While there are challenges related to high treatment costs and side effects, the overall financial trajectory indicates a positive outlook.

Key Takeaways

• Market Growth: The Afatinib dimaleate market is expected to grow at a notable CAGR from 2024 to 2031.
• Clinical Efficacy: Afatinib dimaleate has demonstrated superior progression-free survival compared to other treatments.
• Budget Impact: Increasing the treatment share of Afatinib dimaleate has a relatively small budget impact on health plans.
• Regional Dominance: North America is expected to dominate the market, followed by Europe and Asia-Pacific.
• Challenges: High treatment costs, side effects, and potential patent expirations are key challenges.

FAQs

Q1: What is Afatinib dimaleate used for? Afatinib dimaleate is used for the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations.

Q2: Who are the main players in the Afatinib dimaleate market? The main players include Boehringer Ingelheim Pharmaceuticals, APExBIO Technology LLC, Carbosynth Ltd, and several others[1].

Q3: What is the expected CAGR of the Afatinib dimaleate market from 2024 to 2031? The market is expected to grow at a notable CAGR, though the exact percentage varies by source[3][4].

Q4: How does Afatinib dimaleate impact health plan budgets? Increasing the treatment share of Afatinib dimaleate results in a relatively small budget impact on health plans, with per-member-per-month increases ranging from $0.00 to $0.03 over a 5-year period[2].

Q5: What are the potential side effects of Afatinib dimaleate? Common side effects include diarrhea, rash, and stomatitis, among others[2].

Sources

1. Global Afatinib Dimaleate Market Research Report - Valuates Reports
2. Budget Impact Analysis of Afatinib for First-Line Treatment of NSCLC - NCBI
3. Afatinib Market Report 2024 (Global Edition) - Cognitive Market Research
4. Afatinib Dimaleate Market Size, Scope And Forecast Report - Market Research Intellect
5. Afatinib dimaleate - Tocris Bioscience

Last updated: 2024-12-17