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Last Updated: December 23, 2024

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ayvakit Drug Patent Profile


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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

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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: 28
Drug Prices: Drug price information for ayvakit
What excipients (inactive ingredients) are in ayvakit?ayvakit excipients list
DailyMed Link:ayvakit at DailyMed
Drug patent expirations by year for ayvakit
Drug Prices for ayvakit

See drug prices for ayvakit

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ayvakit
Generic Entry Date for ayvakit*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all ayvakit clinical trials

US Patents and Regulatory Information for ayvakit

ayvakit is protected by fourteen US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ayvakit is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 8054
Patent: COMPUESTOS ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 14337314
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2016008541
Patent: composições úteis para tratar distúrbios relacionados a kit
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 26999
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIES A L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

China

Patent: 5658652
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷  Subscribe

Patent: 0003217
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to KIT)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0181388
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 21182
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 57969
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 57969
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIÉS À L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

Patent: 09674
Patent: COMPOSITIONS UTILES POUR TRAITER DES TROUBLES ASSOCIÉS À UN KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 21461
Patent: 可用於治療與 相關的病症的組合物 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT KIT)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 39687
Estimated Expiration: ⤷  Subscribe

Patent: 59041
Estimated Expiration: ⤷  Subscribe

Patent: 100006
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 4677
Patent: תכשירים יעילים לטיפול בהפרעות הקשורות ל- kit (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 46040
Estimated Expiration: ⤷  Subscribe

Patent: 82756
Estimated Expiration: ⤷  Subscribe

Patent: 16538257
Patent: KITに関連する疾患を治療するために有用な組成物
Estimated Expiration: ⤷  Subscribe

Patent: 19048878
Patent: KITに関連する疾患を治療するために有用な組成物 (COMPOSITION USEFUL FOR TREATMENT OF DISEASED RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 057969
Estimated Expiration: ⤷  Subscribe

Patent: 2021003
Estimated Expiration: ⤷  Subscribe

Patent: 57969
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 5614
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷  Subscribe

Patent: 16004927
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷  Subscribe

Netherlands

Patent: 1094
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 8075
Patent: Compositions useful for treating disorders related to kit
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 21012
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 016500611
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 57969
Estimated Expiration: ⤷  Subscribe

Patent: 09674
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 57969
Estimated Expiration: ⤷  Subscribe

Patent: 09674
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 06235
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ РАССТРОЙСТВ, СВЯЗАННЫХ С KIT (COMPOSITIONS SUITABLE FOR TREATING DISORDERS ASSOCIATED WITH KIT)
Estimated Expiration: ⤷  Subscribe

Patent: 16118768
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 542
Patent: KOMPOZICIJE KORISNE ZA LEČENJE POREMEĆAJA POVEZANIH SA KIT-OM (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201602937U
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 57969
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1601970
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2378689
Estimated Expiration: ⤷  Subscribe

Patent: 160062173
Patent: KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 83127
Estimated Expiration: ⤷  Subscribe

Patent: 23888
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 83814
Estimated Expiration: ⤷  Subscribe

Patent: 1546062
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 787
Patent: COMPOSICIONES ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
Estimated Expiration: ⤷  Subscribe

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
Portugal 3057969 ⤷  Subscribe
Taiwan I683814 ⤷  Subscribe
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) ⤷  Subscribe
Japan 2022526438 (S)-1-(4-フルオロフェニル)-1-(2-(4-(6-(1-メチル-1H-ピラゾール-4-イル)ピロロ[2,1-F][1、2,4]トリアジン-4-イル)ピペラジニル)-ピリミジン-5-イル)エタン-1-アミンの結晶形態及び製造方法 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2015057873 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ayvakit

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3057969 2021C/509 Belgium ⤷  Subscribe PRODUCT NAME: AVAPRITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969 PA2021003,C3057969 Lithuania ⤷  Subscribe PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 CR 2021 00008 Denmark ⤷  Subscribe PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1473 20200925
3057969 PA2021003 Lithuania ⤷  Subscribe PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 LUC00199 Luxembourg ⤷  Subscribe PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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"

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.