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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 seven patents protecting this drug.

This drug has sixty-seven patent family members in thirty-three 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.

Indicators of Generic Entry

Summary for AYVAKIT

International Patents:	67
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	1
Patent Applications:	33
Drug Prices:	Drug price information 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:

9,200,002

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 fourteen US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,200,002.

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	212608-001	Jan 9, 2020		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No	11,999,744
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No	12,060,354
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	9,200,002		Y	Y

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/005208 Ayvakyt 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

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	4302761	FORMES CRISTALLINES DE (S)-1-(4-FLUOROPHÉNYL)-1-(2-(4-(6-(1-MÉTHYL-1H-PYRAZOL-4-YL))PYRROLO[2,1-F][1,2,4]TRIAZIN-4-YL)PIPÉRAZINYL)-PYRIMIDIN-5-YL)ÉTHAN-1-AMINE ET DES PROCÉDÉS DE FABRICATION (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)
Taiwan	I683814
Denmark	3057969
South Africa	201601970	COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Israel	244677	תכשירים יעילים לטיפול בהפרעות הקשורות ל- kit (Compositions useful for treating disorders related to kit)

Supplementary Protection Certificates for AYVAKIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3057969	2021C/509	Belgium		PRODUCT NAME: AVAPRITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969	SPC/GB21/020	United Kingdom		PRODUCT NAME: AVAPRITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK PLGB52115/0001-0003 20200925; UK EU/1/20/1473(NI) 20200925
3057969	PA2021003	Lithuania		PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969	CR 2021 00008	Denmark		PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1473 20200925
3057969	LUC00199	Luxembourg		PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925

AYVAKIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AYVAKIT

Introduction

AYVAKIT, a tyrosine kinase inhibitor developed by Blueprint Medicines, has been making significant strides in the pharmaceutical market, particularly since its indication expansion for indolent systemic mastocytosis (ISM). Here, we delve into the market dynamics and financial trajectory of AYVAKIT, highlighting key milestones, growth drivers, and future outlook.

Expansion into Indolent Systemic Mastocytosis (ISM)

In May 2023, AYVAKIT received FDA approval for the treatment of ISM, a less severe but more common form of systemic mastocytosis compared to advanced SM (ASM)[1][4].

• This expansion has been a pivotal factor in AYVAKIT's growth, with ISM now representing approximately 57% of AYVAKIT's unique patients[1].

Patient Growth and Market Impact

Since the ISM indication expansion, AYVAKIT has seen a substantial increase in patient numbers.

• Quarterly unique patients have more than tripled from 2Q2023 to 2Q2024, according to Earnest pharmacy claims data[1].
• This growth mirrors the acceleration in company-reported U.S. product revenue, indicating strong market acceptance and penetration[1].

Revenue Growth and Financial Performance

AYVAKIT's revenue has shown remarkable growth year-over-year.

• In the third quarter of 2024, AYVAKIT sales reached $128.2 million, a 137% increase from the previous year[2].
• For 2024, Blueprint Medicines has raised its revenue guidance to $475 million to $480 million, reflecting continued strong performance and favorable commercial mix[2].

Peak Sales Estimate

The success of AYVAKIT has led Blueprint Medicines to revise its peak sales estimate upward.

• The company now estimates AYVAKIT's peak sales potential to be over $2 billion, a significant increase from the previous estimate of $1.5 billion[1][4].

International Expansion and Market Reach

International markets, particularly in Europe, have contributed significantly to AYVAKIT's top-line growth.

• The drug's performance in countries like Germany has been strong, with international business on track to breakeven by the end of 2024[3].

Clinical Impact and Prescriber Base

AYVAKIT's clinical impact and positive patient experiences have driven its market success.

• The drug has seen low discontinuation rates and strong prescribing patterns across various specialties and settings[3].
• The breadth and depth of the prescriber base have been key indicators of revenue growth, with continued expansion in this area expected to drive future sales[3].

Financial Position and Operational Efficiency

Blueprint Medicines has maintained a strong financial position.

• As of the third quarter of 2024, the company had $882.4 million in cash and anticipates reduced cash burn rates[2].
• The company's gross to net margin remains stable in the mid-80s, indicating efficient operational management[2].

Future Outlook and Milestones

Blueprint Medicines is focused on sustaining AYVAKIT's growth through several strategies.

• Continued investment in the mast cell portfolio and patient retention strategies are key priorities[2].
• Upcoming milestones include studies for elenestinib and advancing BLU-808 through Phase 1 trials, which could further enhance the company's product pipeline[2].

Seasonal Variability and Long-Term Growth

While seasonal factors may cause variability in patient starts, the long-term growth trajectory for AYVAKIT remains strong.

• The company is in the early stages of a launch with significant growth potential, suggesting a path to breakeven may be ahead[2].

Comparison with Other Blockbuster Drugs

Blueprint Medicines' COO, Christy Rossi, has compared AYVAKIT's launch trajectory to other blockbuster rare disease medications like Incyte’s Jakafi and AstraZeneca’s Soliris.

• These drugs have continued to see revenue growth over the years despite competitor launches, suggesting a similar potential for AYVAKIT[4].

Direct-to-Consumer Campaigns

Direct-to-consumer campaigns are expected to further drive AYVAKIT's growth.

• Continued investments in these campaigns, especially in the second half of 2024, are planned to increase awareness and adoption of the drug[3].

Key Takeaways

• AYVAKIT's patient base has tripled since the ISM indication expansion.
• Revenue has grown significantly, with a 137% year-over-year increase in the third quarter of 2024.
• The peak sales estimate for AYVAKIT has been raised to over $2 billion.
• International expansion and strong prescriber base growth are driving factors.
• Blueprint Medicines maintains a strong financial position and is focused on sustaining growth through various strategies.

FAQs

Q: What was the impact of the ISM indication expansion on AYVAKIT's patient numbers?

A: The ISM indication expansion led to a tripling of AYVAKIT's quarterly unique patients from 2Q2023 to 2Q2024[1].

Q: How has AYVAKIT's revenue performed in recent quarters?

A: AYVAKIT sales reached $128.2 million in the third quarter of 2024, a 137% increase year-over-year[2].

Q: What is the current peak sales estimate for AYVAKIT?

A: The peak sales estimate for AYVAKIT has been raised to over $2 billion[1][4].

Q: How is Blueprint Medicines performing financially?

A: As of the third quarter of 2024, Blueprint Medicines had $882.4 million in cash and anticipates reduced cash burn rates[2].

Q: What are the key drivers of AYVAKIT's growth?

A: Key drivers include the ISM indication expansion, international market growth, strong prescriber base expansion, and positive patient experiences[1][2][3].

Sources

1. Earnest Analytics: "Blueprint poised to elevate Ayvakit to blockbuster status with rapid growth in ISM"
2. Investing.com: "Earnings call: Blueprint Medicines sees revenue soar with AYVAKIT sales"
3. Investing.com: "Earnings call: Blueprint Medicines raises AYVAKIT guidance amid growth"
4. Fierce Pharma: "Blueprint boosts Ayvakit peak sales estimate to $2B - Fierce Pharma"