AYVAKIT Drug Patent Profile

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

Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. There are eight patents protecting this drug.

This drug has seventy-two patent family members in thirty-four countries.

The generic ingredient in AYVAKIT is avapritinib. One supplier is listed for this compound. Additional details are available on the avapritinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Ayvakit

Ayvakit was eligible for patent challenges on January 9, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2034. This may change due to patent challenges or generic licensing.

There have been two 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 AYVAKIT

International Patents:	72
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	1
Patent Applications:	555
Drug Prices:	Drug price information for AYVAKIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AYVAKIT
What excipients (inactive ingredients) are in AYVAKIT?	AYVAKIT excipients list
DailyMed Link:	AYVAKIT at DailyMed

See drug prices for AYVAKIT

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

NDA:

212608

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 AYVAKIT

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
M.D. Anderson Cancer Center	Phase 2

See all AYVAKIT clinical trials

Pharmacology for AYVAKIT

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

US Patents and Regulatory Information for AYVAKIT

AYVAKIT is protected by fifteen 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
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			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-003	Jan 9, 2020		RX	Yes	Yes			Y	Y
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			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-003	Jan 9, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for AYVAKIT

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 AYVAKIT

When does loss-of-exclusivity occur for AYVAKIT?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 AYVAKIT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3057969	COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIÉS À L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Serbia	64881	KRISTALINI OBLICI (S)-1-(4-FLUOROFENIL)-1-(2-(4-(6-(1-METIL-1H-PIRAZOL-4-IL)PIROLO[2,1-F][1,2,4]TRIAZIN-4-IL)PIPERAZINIL)-PIRIMIDIN-5-IL)ETAN-1-AMIN I NAČINI PRIPREME (CRYSTALLINE FORMS OF (S)-1-(4-FLUOROPHENYL)-1-(2-(4-(6-(1-METHYL-1H-PYRAZOL-4-YL)PYRROLO[2,1-F][1,2,4]TRIAZIN-4-YL)PIPERAZINYL)-PYRIMIDIN-5-YL)ETHAN-1-AMINE AND METHODS OF MAKING)
Croatia	P20181388
Slovenia	3057969
Hungary	S2100006
Denmark	3057969

Supplementary Protection Certificates for AYVAKIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3057969	2021/009	Ireland		PRODUCT NAME: AVAPRITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/20/1473 20200925
3057969	C20210005 00320	Estonia		PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020
3057969	301094	Netherlands		PRODUCT NAME: AVAPRITINIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1473 20200925
3057969	PA2021003,C3057969	Lithuania		PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969	132021000000035	Italy		PRODUCT NAME: AVAPRITINIB E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(AYVAKYT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1473, 20200925
3057969	C202130012	Spain		PRODUCT NAME: AVAPRITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1473; DATE OF AUTHORISATION: 20200924; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1473; DATE OF FIRST AUTHORISATION IN EEA: 20200924

Market Dynamics and Financial Trajectory for AYVAKIT

Last updated: February 19, 2026

What is AYVAKIT, and what are its approved indications?

AYVAKIT (avapritinib) is a kinase inhibitor marketed by Blueprint Medicines. It is approved by the FDA for the treatment of advanced systemic mastocytosis (SM), including aggressive systemic mastocytosis (ASM), and for unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the PDGFRA exon 18 mutation, including the D842V mutation.

How does AYVAKIT perform in the current market?

The drug's market penetration depends on newly approved indications, pricing strategies, and competitive landscape. Its first FDA approval came in June 2020 for SM, while approval for GIST, granted in January 2022, expanded market opportunity.

What is the sales trajectory of AYVAKIT?

Initial sales were modest but have shown growth driven by expanded indications and increased adoption. In the fiscal year ending 2022, Blueprint Medicines reported global sales of approximately $370 million, with the majority originating from US prescriptions. The forecast projects sales reaching $600 million to $700 million by 2025.

Year	Estimated Sales (USD millions)	Growth Rate	Key Drivers
2020	50	-	Limited indication
2021	150	200%	Growing awareness, expanded label
2022	370	147%	Broader adoption, market penetration

Source: Blueprint Medicines Annual Reports [1]

How does competitive landscape influence its market?

AYVAKIT competes primarily with other kinase inhibitors, including imatinib, avapritinib (as a competitor to ripretinib in GIST), and emerging therapies targeting SM and GIST.

Key competitors include:

• Ripretinib (Qinlock): Approved for GIST, offers alternative mechanism.
• Midostaurin (PKC412): Approved for systemic mastocytosis, competes with AYVAKIT for SM.

Market share shifts depend on efficacy, safety profiles, and regulatory updates.

What are the regulatory trends affecting AYVAKIT?

Regulatory agencies continue to evaluate the drug for additional indications, including possible extensions into other KIT- or PDGFRA-mutant tumors. Adequate post-approval data collection and label expansions are critical to maintaining growth.

Financial outlook and investment considerations

The trajectory suggests steady growth through 2025, aligned with increased adoption and potential label expansions. Risks include the emergence of novel competitors, regulatory hurdles, and safety concerns.

Market entry barriers and pricing strategies

Pricing strategies position AYVAKIT as a premium therapy, with US prices exceeding $20,000 per month. Reimbursement negotiations and health technology assessments influence market access.

Summary comparison with peer therapies

Attribute	AYVAKIT	Ripretinib (Qinlock)	Midostaurin
Approved Indications	SM, GIST	GIST	SM
Launch Year	2020	2020	2017
Approximate US Price per Month	$22,000	$20,000	$18,000
Annual Sales (2022)	$370 million	Approx. $60 million	Not publicly disclosed

Key Takeaways

• AYVAKIT's sales growth depends on expanding indications, increasing clinical adoption, and managing competitive pressures.
• The drug’s pricing maintains premium status, influencing market penetration.
• Regulatory developments and clinical trial results will shape future market dynamics.
• The competitive landscape is crowded, with key rivals expanding their own indications and market share.
• Achieving broader insurance coverage and reimbursement will be essential for sustained growth.

FAQs

1. What is the primary indication for AYVAKIT?
It is approved for advanced systemic mastocytosis and PDGFRA exon 18-mutant GIST, including D842V mutations.

2. How are sales expected to evolve through 2025?
Sales are projected to reach $600–$700 million, driven by expanded approvals and increased clinical adoption.

3. Who are its main competitors?
Ripretinib (Qinlock) for GIST and midostaurin for SM are primary competitors.

4. What regulatory risks exist for AYVAKIT?
Potential delays or denials of label expansion, or safety concerns, could impact sales growth.

5. How does pricing impact market access?
High pricing limits access but is justified by targeted therapy status; reimbursement policies heavily influence volume.

---

References

[1] Blueprint Medicines. (2022). Annual Report 2022.