AVAPRITINIB - Generic Drug Details

What are the generic drug sources for avapritinib and what is the scope of freedom to operate?

Avapritinib is the generic ingredient in one branded drug marketed by Blueprint Medicines and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avapritinib has seventy-one patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for AVAPRITINIB

International Patents:	71
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	21
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVAPRITINIB
What excipients (inactive ingredients) are in AVAPRITINIB?	AVAPRITINIB excipients list
DailyMed Link:	AVAPRITINIB at DailyMed

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

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 AVAPRITINIB

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

Sponsor	Phase
The First Affiliated Hospital of Soochow University	PHASE1
Ruijin Hospital	PHASE2
Institute of Hematology & Blood Diseases Hospital, China	PHASE2

See all AVAPRITINIB clinical trials

Pharmacology for AVAPRITINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AVAPRITINIB

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for AVAPRITINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-003	Jan 9, 2020		RX	Yes	Yes
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No

EU/EMA Drug Approvals for AVAPRITINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Blueprint Medicines (Netherlands) B.V.	Ayvakyt	avapritinib	EMEA/H/C/005208Ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.	Authorised	no	no	yes	2020-09-24

International Patents for AVAPRITINIB

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1221461
Singapore	11201602937U	COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Taiwan	I683814
Japan	6446040
Taiwan	202104232
Russian Federation	2016118768	COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT

Supplementary Protection Certificates for AVAPRITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3057969	132021000000035	Italy		PRODUCT NAME: AVAPRITINIB E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(AYVAKYT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1473, 20200925
3057969	21C1013	France		PRODUCT NAME: AVAPRITINIB ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/20/1473 20200925; FIRST REGISTRATION: - EU/1/20/1473 20200925
3057969	2021C/509	Belgium		PRODUCT NAME: AVAPRITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969	C03057969/01	Switzerland		PRODUCT NAME: AVAPRITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68294 06.07.2023
3057969	10/2021	Austria		PRODUCT NAME: AVAPRITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1473 (MITTEILUNG) 20200925
3057969	CA 2021 00008	Denmark		PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1473 20200925

Market Dynamics and Financial Trajectory for AVAPRITINIB

Last updated: October 2, 2025

Introduction

AVAPRITINIB stands as a promising agent in the evolving landscape of targeted cancer therapies, specifically targeting conditions such as epidermal growth factor receptor (EGFR) positive non-small cell lung cancer (NSCLC) and other oncologic indications. As a potent kinase inhibitor, AVAPRITINIB’s development trajectory, market adoption, and financial prospects are shaped by intricate dynamics within the pharmaceutical industry, competitive landscapes, regulatory paradigms, and emerging scientific evidence.

This report provides an in-depth analysis of the key market forces influencing AVAPRITINIB’s commercial potential, investment outlook, and trajectory in the pharmaceutical sector.

Pharmaceutical Market Context and Therapeutic Opportunity

Target Disease Landscape

The global NSCLC market was valued at approximately US$21 billion in 2022, with targeted therapies comprising a significant share due to their superior efficacy over traditional chemotherapy [1]. The subset of EGFR-positive NSCLC patients represents a lucrative segment, with approximately 10-15% of Western and up to 30-50% of Asian populations exhibiting this mutation [2].

Emerging resistance to first- and second-generation EGFR inhibitors has created an urgent need for next-generation agents like AVAPRITINIB, designed to overcome mutation-driven resistance mechanisms such as T790M and C797S mutations. This focus aligns the drug with crucial unmet needs in oncology, underpinning its potential market penetration.

Mechanism of Action and Competitive Positioning

AVAPRITINIB operates as a selective, irreversible EGFR tyrosine kinase inhibitor (TKI). Its capacity to target resistance-associated mutations positions it favorably against existing therapies such as osimertinib, which, while effective, faces resistance challenges and limited durability in some cases [3].

The competitive landscape includes established drugs like AMG 510, lazertinib, and other emerging irreversible EGFR inhibitors. However, AVAPRITINIB’s unique molecular profile and clinical trial data—pending or emerging—may carve a niche within this segment when backed by robust efficacy and safety profiles.

Regulatory and Developmental Milestones

Pipeline Status and Clinical Trials

AVAPRITINIB is in multiple clinical trial phases—most notably Phase II/III studies assessing efficacy, safety, and long-term outcomes. Key trials such as the AURA and RELIEVE studies are critical for regulatory submissions and eventual market approval in major territories (U.S., Europe, Asia) [4].

Regulatory Outlook

Securing accelerated approval pathways, such as Breakthrough Therapy Designation or Priority Review, depends on early clinical results demonstrating substantial therapeutic benefit. Such designation could expedite market access, impacting financial expectations favorably.

Market Dynamics Influencing AVAPRITINIB

Competitive Intensity

The targeted oncology space remains highly competitive, with a high influx of innovative agents. Recent approvals of third-generation TKIs have intensified market competition, yet AVAPRITINIB’s differentiated targeting of specific resistance mutations could confer advantages.

Moreover, partnerships or collaborations with major biotech and pharma firms could accelerate development and commercialization, affecting market dynamics by expanding distribution channels and advancing scientific validation.

Pricing and Reimbursement

Pricing strategies hinge upon demonstrated clinical benefit, safety profile, and comparative efficacy. Given the oncology drug pricing landscape—often premium—market success hinges on reimbursement frameworks across regions. Payers’ acceptance is contingent on solid evidence of incremental value over existing therapies.

Intellectual Property and Patent Strength

Proprietary formulations and method-of-use patents secure competitive advantages essential for long-term profitability. Patent life extensions and supplementary protection certificates (SPCs) can prolong market exclusivity, positively influencing revenue streams.

Market Penetration Strategies

Early adoption by key opinion leaders, inclusion in clinical guidelines, and successful outcomes in real-world settings are pivotal. Educational initiatives and post-marketing studies will strengthen market presence and facilitate prescriber confidence.

Financial Trajectory Projections

Revenue Growth Expectations

Forecasts indicate a potential peak annual sales of US$1-3 billion for AVAPRITINIB within 5-7 years post-approval, assuming successful phase III outcomes and wide adoption. Growth trajectory depends heavily on the drug’s demonstrated efficacy in resistant cases and its safety profile.

Cost Structures and Investment

Development costs—including clinical trials, regulatory processes, and commercialization—are substantial, often exceeding hundreds of millions of dollars. Early-stage investments, coupled with strategic partnerships, are crucial to mitigate financial risk and accelerate pathway to revenues.

Market Entry and Commercialization Costs

Initial market entry costs encompass regulatory filings, marketing, physician education, and patient access programs. Post-launch, sustained investment will be necessary for pharmacovigilance and expanding indications.

Profitability Timeline

Given the typical time lag of 7-10 years from discovery to revenue generation in oncology drugs, profitability hinges on earlier approvals, market acceptance, and price premiums justified by clinical benefits.

Risks and Uncertainties

• Regulatory Delays: Additional data requisites or unfavorable trial outcomes could hinder approval timelines.
• Competitive Dynamics: Rapid advancements by rivals may erode AVAPRITINIB’s market share.
• Pricing Pressure: Payer negotiations and health policy shifts could impact profit margins.
• Pricing and Reimbursement: Variability in regional reimbursement policies affects market access and revenue potential.
• Scientific Validity: Unanticipated safety concerns or limited efficacy could reduce market viability.

Conclusion

AVAPRITINIB’s prospects are strongly tied to its clinical trial outcomes, regulatory acceptance, and positioning against existing therapies. The drug’s ability to address unmet needs—particularly in resistant EGFR-positive NSCLC—augments its revenue potential. Strategic collaborations, effective patent protections, and targeted market entry will be pivotal in realizing its financial trajectory.

Key Takeaways

• Targeted niche within oncology offers high upswing potential for AVAPRITINIB, primarily due to its activity against resistant mutations.
• Regulatory success in upcoming clinical trials is crucial for early market entry and financial viability.
• Competitive landscape remains intense; differentiation through efficacy and safety will influence market share.
• Pricing and reimbursement strategies will directly impact revenue streams, necessitating robust health economics data.
• Strategic partnerships can enhance development efficiency, expedite approval, and broaden market access, positively influencing the financial outlook.

FAQs

1. What is the primary therapeutic focus of AVAPRITINIB?
   AVAPRITINIB is primarily developed to target EGFR-positive NSCLC, particularly addressing resistance mutations such as T790M and C797S, offering a potential solution for patients with limited options.

2. When is AVAPRITINIB expected to reach markets?
   Pending successful clinical trial outcomes and regulatory review, AVAPRITINIB may achieve market approval within 3-5 years, though timelines depend on trial results and regional processes.

3. How does AVAPRITINIB compare to existing EGFR inhibitors?
   Its distinguishing feature is potent activity against resistance mutations, potentially offering increased efficacy and durability compared to current first- and second-generation inhibitors like gefitinib or osimertinib.

4. What are the main market entry barriers for AVAPRITINIB?
   Regulatory hurdles, high development costs, competitive saturation, payer reimbursement policies, and securing significant clinical differentiation pose the primary challenges.

5. What is the potential revenue range for AVAPRITINIB?
   Market projections suggest peak annual revenues of approximately US$1-3 billion, influenced by clinical success, market acceptance, and regional adoption strategies.

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Sources
[1] MarketWatch. "Global Non-Small Cell Lung Cancer Therapeutics Market." 2022.
[2] American Cancer Society. "Targeted Therapy for Lung Cancer." 2023.
[3] Journal of Clinical Oncology. "Resistance to EGFR Tyrosine Kinase Inhibitors." 2022.
[4] ClinicalTrials.gov. "AVAPRITINIB Clinical Trial Registry." 2023.