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-three 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 May 22, 2030. This may change due to patent challenges or generic licensing.

There have been three 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:	73
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	1
Patent Applications:	502
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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)

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

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM).

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	12,060,354
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No	11,964,980		Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-003	Jan 9, 2020		RX	Yes	Yes	9,994,575		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	9,200,002		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
Canada	3136707
Canada	3296895
China	113966334
Denmark	3856341
European Patent Office	3856341
European Patent Office	4302761

Supplementary Protection Certificates for AYVAKIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3057969	301094	Netherlands		PRODUCT NAME: AVAPRITINIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1473 20200925
3057969	PA2021003	Lithuania		PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969	LUC00199	Luxembourg		PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969	122021000014	Germany		PRODUCT NAME: AVAPRITINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; AUTHORISATION NO/DATE: EU/1/20/1473 20200924
3057969	CA 2021 00008	Denmark		PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: 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

AYVAKIT (avapritinib) market dynamics and financial trajectory: pricing, uptake, competition, and exclusivity-to-revenue timeline

Last updated: July 27, 2026

AYVAKIT (avapritinib) is positioned for treatment of advanced gastrointestinal stromal tumor (GIST) after prior therapy and for PDGFRA exon 18 mutant disease, with additional label expansion over time. Market dynamics are driven by (1) second-line and later-line GIST conversion from surgery/other tyrosinase inhibitors and (2) PDGFRA exon 18 mutation concentration in a narrow biomarker-defined patient set. Financial trajectory is shaped by prescription growth from new lines of therapy, payor contracting, and competitive pressure from other kinase inhibitors and later-line sequencing.

What is the sales and revenue trajectory for AYVAKIT (avapritinib) over time?

Answer: AYVAKIT’s commercial path reflects early launch ramp in advanced GIST and subsequent label-driven expansions. Revenue performance has depended on increasing share in later-line GIST, sustained uptake in PDGFRA exon 18, and the broader oncology spend environment.

Key commercial drivers by indication

• Advanced GIST (later-line): Uptake depends on treatment sequencing after imatinib and sunitinib (and in many markets, after regorafenib where used). Avapritinib’s adoption is sensitive to guideline sequencing, prescriber comfort, and payer rules that require molecular testing or prior-therapy documentation.
• PDGFRA exon 18 mutant GIST: A narrower biomarker-defined population typically supports more predictable conversion once testing is available, but total addressable demand is smaller than GIST overall.
• Line-of-therapy and geography: Oncology spend allocation and hospital formularies drive share more than headline incidence. Financial trajectory differs between US, EU5, and Japan based on reimbursement timing and access restrictions.

High-level timeline logic for financial modeling

• Pre-expansion: Ramp in GIST requires evidence-based positioning after earlier TKIs.
• Post-expansion: Each label expansion increases addressable patients, but revenue growth rate slows as penetration saturates and competition tightens.
• Generic/biosimilar risk: Avapritinib is a small-molecule oncology drug. Pricing pressure in the long-run is tied to patent/exclusivity expiry rather than near-term biosimilar substitution.

(Source note: The prompt did not include financial statements, segment revenue tables, analyst consensus estimates, or specific quarter-by-quarter AYVAKIT numbers. Without those data points, no defensible numeric revenue trajectory can be produced here.)

What market dynamics are shaping AYVAKIT uptake in GIST and PDGFRA exon 18?

Answer: Uptake is driven by biomarker testing access, therapy sequencing rules, and payer restrictions that often require prior TKI exposure or confirmed mutation status.

How patient selection affects demand

• GIST is heterogeneous. Adoption depends on the proportion of patients who are eligible based on prior therapy history and who have access to molecular characterization where required.
• PDGFRA exon 18 is narrower. The market is smaller but can convert strongly when testing infrastructure exists and prescribers treat with guideline-consistent molecular targeting.

How payer and reimbursement shape volume

• Prior authorization and step therapy can delay time-to-treatment and reduce net paid prescriptions.
• Indication-specific coverage means payer behavior can shift quickly when labeling or compendia guidance changes.
• Contracting dynamics (rebates, discounts) directly affect net sales growth even when prescription counts rise.

Treatment setting and oncology channel behavior

• Uptake is concentrated in academic centers and high-volume oncology practices early, then broadens as community adoption follows clinical guideline updates.
• Dispensing channel is typically specialty pharmacy or hospital outpatient, affecting the speed of uptake and how quickly net sales reflect new patient starts.

How does AYVAKIT pricing and contracting affect net sales growth versus prescription growth?

Answer: Net sales growth depends on the spread between gross price and realized price after rebates/discounts, which can move independently from prescription trends.

Market mechanics that move realized pricing

• Formulary placement: Narrow formulary access increases reliance on contracting and can raise realized price variability.
• Competitive pricing pressure: When competitors broaden coverage or show superior convenience, payers push net price down.
• Outcome narratives and guideline placement: Stronger positioning improves odds of payer exceptions and favorable contracting.

What to watch in quarterly reporting

• Net sales vs. Rxs divergence: If Rxs increase but net sales lag, contracting has likely worsened.
• Seasonality: Specialty oncology demand is less seasonal than primary care, but payer cycles can create quarter-end artifacts.

(This section provides the mechanism; it does not provide numeric realized price or prescription metrics, because no AYVAKIT financial statement figures were supplied.)

How strong is the competitive landscape for AYVAKIT in advanced GIST?

Answer: Competition is driven by next-therapy sequencing in later-line GIST and by targeted alternatives depending on mutation profiles, patient comorbidities, and tolerability.

Competitor set by mechanism and typical sequencing

• KIT/PDGFRA TKIs and later-line options: Market share shifts with updated sequencing guidelines and local formularies.
• Other targeted therapies: Adoption patterns depend on mutation coverage and adverse event profiles that determine regimen switching.

What drives share shifts

• Tolerability and dose management: When adverse event handling is manageable, conversion rates rise.
• Clinical trial endpoints that map to practice: Durability, response rate, and progression-free survival influence formulary committee decisions.
• Local access: If competitors get broad coverage earlier in a region, they can entrench share before AYVAKIT benefits from additional label clarity.

What is the exclusivity-to-revenue timeline for AYVAKIT, and when does revenue risk rise?

Answer: Revenue risk rises near the end of patent term and additional exclusivity windows, as payers and providers anticipate generics and shift contracting strategy.

How to interpret “exclusivity” in revenue planning

• Patent term limits generic entry; regulatory exclusivity (if applicable) can extend effective market protection.
• Revenue risk accelerates when:
  • patent challenges are filed (Paragraph IV in the US, where relevant),
  • settlement timelines crystallize,
  • payers begin preemptive contracting for expected generic availability.

Practical modeling framework

• Revenue curves tend to:
  • grow as indications expand and conversion increases,
  • plateau as penetration approaches saturation,
  • decline when generic entry risk becomes concrete.

(No specific AYVAKIT patent expiration dates, Orange Book listings, or exclusivity end dates were provided in the prompt. A timeline with dates and patent numbers would not be accurate without those inputs.)

What regulatory and clinical milestones affect AYVAKIT financial trajectory?

Answer: Label changes, FDA supplemental approvals, and safety communications can shift both volume and realized pricing.

Milestones that tend to move financials

• FDA approvals for additional indications: Increase addressable patient populations.
• Safety label updates: Can reduce physician willingness to use the drug in marginal cases.
• Post-marketing requirements: Sometimes slow adoption until additional evidence is consolidated.

How clinical evidence translates to adoption

• If new data improves expected durability or shifts the benefit-risk profile, formulary committees update.
• If competing evidence suggests alternative TKIs provide better tolerability or response, share shifts.

(No specific FDA dates or milestone list were included in the prompt; providing a date-specific milestone table would require primary regulatory records.)

How does AYVAKIT compare with other GIST drugs on market position and financial exposure?

Answer: AYVAKIT’s financial exposure is most sensitive to:

1. its share of later-line GIST and
2. biomarker-driven PDGFRA exon 18 utilization.

Other drugs may see different exposure profiles based on broader patient coverage or less reliance on narrow molecular inclusion.

Competitive comparison structure (for internal planning)

• Coverage breadth: proportion of GIST patients reachable without restrictive biomarker/eligibility rules.
• Line-of-therapy dependence: whether use is primarily later-line.
• Payor stickiness: history of contracting stability and prior authorization friction.
• Safety/tolerability: impact on switching and dosing interruptions.

(Without numeric market share and revenue by competitor, no quantitative comparison can be made.)

What patent and generic-entry risks exist for AYVAKIT, and how could they change sales?

Answer: Generic entry risk depends on the drug’s US patent and exclusivity landscape and whether competitors file abbreviated applications that trigger litigation or settlement.

Typical risk channels for small-molecule oncology

• Paragraph IV filings can force litigation and create timeline uncertainty, sometimes with delayed entry via settlements.
• Formulation or method-of-use patents can delay generic launch if they are asserted and upheld.
• Skin-in-the-game economics: Even before legal barriers fall, payers may begin shifting preferred agents once entry becomes plausible.

(This prompt did not include Orange Book or litigation records. Without them, this section cannot identify specific patents, expiry dates, challengers, or settlement timing.)

Key Takeaways

• AYVAKIT’s market dynamics are driven by biomarker-defined demand (PDGFRA exon 18), plus later-line GIST sequencing where payer rules and prescriber practice determine conversion.
• Net sales growth depends on contracting and realized price, not only prescription volume.
• The financial trajectory follows an oncology pattern: ramp with label-driven expansion, plateau with penetration saturation, and revenue risk that rises as generic entry probability increases near end-of-exclusivity and patent expiry.
• A date-specific exclusivity and competitive entry plan requires the drug’s Orange Book listings, patent expiration set, and any Paragraph IV and settlement events; those inputs were not included in the prompt, so no numeric timeline can be stated.

FAQs

1. How do payers determine prior authorization for AYVAKIT in later-line GIST?
2. What biomarkers most influence AYVAKIT prescribing decisions in advanced GIST?
3. How do safety/tolerability updates impact AYVAKIT market share versus competing TKIs?
4. What market share indicators best predict AYVAKIT sales acceleration or plateau?
5. How does US regulatory exclusivity end-of-protection timing typically translate into generic launch pricing pressure?

References

1. (No citable sources were provided in the prompt.)

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