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Last Updated: June 27, 2022

VITRAKVI Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Vitrakvi

Vitrakvi will be eligible for patent challenges on November 26, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VITRAKVI
International Patents:193
US Patents:16
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 5
Patent Applications: 132
Drug Prices: Drug price information for VITRAKVI
What excipients (inactive ingredients) are in VITRAKVI?VITRAKVI excipients list
DailyMed Link:VITRAKVI at DailyMed
Drug patent expirations by year for VITRAKVI
Drug Prices for VITRAKVI

See drug prices for VITRAKVI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VITRAKVI
Generic Entry Dates for VITRAKVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for VITRAKVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 VITRAKVI

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
Children's Oncology GroupPhase 2
Merck Sharp & Dohme Corp.Phase 2

See all VITRAKVI clinical trials

Pharmacology for VITRAKVI

US Patents and Regulatory Information for VITRAKVI

VITRAKVI is protected by seventeen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VITRAKVI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VITRAKVI

Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING NEUROBLASTOMA, GLIOMA, THYROID, AND BREAST CANCER SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

Methods of treating pediatric cancers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CMN, IFS, HGG, DIPGS, PTC, SOFT TISSUE SARCOMA, AND SPINDLE CELL SARCOMA SOLID TUMORS EXHIBITING AN NTRK GENE FUSION IN A PEDIATRIC PATIENT WITH AN ORAL SOLUTION

Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION AFTER SURGICAL RESECTION

Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-YL)-pyrazolo[1,5-A]pyri- midin-3-YL)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING LUNG CANCER, UNDIFFERENTIATED SARCOMA, OR COLORECTAL CANCER THAT EXHIBITS AN NTRK GENE FUSION

Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CANCEROUS SOLID TUMORS

Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CANCEROUS SOLID TUMORS

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION IN A PEDIATRIC PATIENT

Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyri- midin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK FUSION GENE IN A PEDIATRIC PATIENT

FDA Regulatory Exclusivity protecting VITRAKVI

INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE NO SATISFACTORY ALTERNATIVE TREATMENTS OR THAT HAVE PROGRESSED FOLLOWING TREATMENT
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC RECEPTOR TYROSINE KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VITRAKVI

When does loss-of-exclusivity occur for VITRAKVI?

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

Argentina

Patent: 8090
Estimated Expiration: See Plans and Pricing

Australia

Patent: 15346046
Estimated Expiration: See Plans and Pricing

Patent: 17246554
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017010141
Estimated Expiration: See Plans and Pricing

Patent: 2018070017
Estimated Expiration: See Plans and Pricing

Patent: 2018070304
Estimated Expiration: See Plans and Pricing

Canada

Patent: 67951
Estimated Expiration: See Plans and Pricing

Patent: 19661
Estimated Expiration: See Plans and Pricing

Patent: 19671
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17001249
Estimated Expiration: See Plans and Pricing

Patent: 18002806
Estimated Expiration: See Plans and Pricing

Patent: 18002807
Estimated Expiration: See Plans and Pricing

Patent: 19002238
Estimated Expiration: See Plans and Pricing

Patent: 19002239
Estimated Expiration: See Plans and Pricing

China

Patent: 7428760
Estimated Expiration: See Plans and Pricing

Patent: 9310694
Estimated Expiration: See Plans and Pricing

Patent: 9414442
Estimated Expiration: See Plans and Pricing

Patent: 3354649
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17005483
Estimated Expiration: See Plans and Pricing

Patent: 18010761
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170263
Estimated Expiration: See Plans and Pricing

Patent: 180501
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 180125
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 018000214
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 18083443
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 18380
Estimated Expiration: See Plans and Pricing

Patent: 39662
Estimated Expiration: See Plans and Pricing

Patent: 39663
Estimated Expiration: See Plans and Pricing

Patent: 99181
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0227339
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 44483
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2270
Estimated Expiration: See Plans and Pricing

Patent: 2003
Estimated Expiration: See Plans and Pricing

Patent: 2005
Estimated Expiration: See Plans and Pricing

Patent: 0905
Estimated Expiration: See Plans and Pricing

Japan

Patent: 14834
Estimated Expiration: See Plans and Pricing

Patent: 17535550
Estimated Expiration: See Plans and Pricing

Patent: 19510827
Estimated Expiration: See Plans and Pricing

Patent: 19511575
Estimated Expiration: See Plans and Pricing

Patent: 21169496
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17006412
Estimated Expiration: See Plans and Pricing

Patent: 18012163
Estimated Expiration: See Plans and Pricing

Patent: 18012165
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 601
Estimated Expiration: See Plans and Pricing

Patent: 610
Estimated Expiration: See Plans and Pricing

Patent: 612
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1800102
Estimated Expiration: See Plans and Pricing

Peru

Patent: 181888
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017500900
Estimated Expiration: See Plans and Pricing

Patent: 018502124
Estimated Expiration: See Plans and Pricing

Patent: 018502134
Estimated Expiration: See Plans and Pricing

Patent: 021550809
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 23990
Estimated Expiration: See Plans and Pricing

Patent: 51636
Estimated Expiration: See Plans and Pricing

Patent: 51767
Estimated Expiration: See Plans and Pricing

Patent: 17120846
Estimated Expiration: See Plans and Pricing

Patent: 18137206
Estimated Expiration: See Plans and Pricing

Patent: 18138579
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201703962X
Estimated Expiration: See Plans and Pricing

Patent: 201808559P
Estimated Expiration: See Plans and Pricing

Patent: 201808676R
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1703501
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170082628
Estimated Expiration: See Plans and Pricing

Patent: 180128484
Estimated Expiration: See Plans and Pricing

Patent: 180129911
Estimated Expiration: See Plans and Pricing

Patent: 210010652
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 46426
Estimated Expiration: See Plans and Pricing

Patent: 46537
Estimated Expiration: See Plans and Pricing

Patent: 1625636
Estimated Expiration: See Plans and Pricing

Patent: 1801730
Estimated Expiration: See Plans and Pricing

Patent: 2206436
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 18000335
Estimated Expiration: See Plans and Pricing

Patent: 18000338
Estimated Expiration: See Plans and Pricing

Patent: 19000332
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3044
Estimated Expiration: See Plans and Pricing

Patent: 5025
Estimated Expiration: See Plans and Pricing

Patent: 5026
Estimated Expiration: See Plans and Pricing

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 VITRAKVI around the world.

Country Patent Number Title Estimated Expiration
Argentina 112833 COMPUESTOS PIRAZOLO[1,5-A]PIRIMIDINA SUSTITUIDA COMO INHIBIDORES DE TRK CINASA See Plans and Pricing
Ukraine 123044 КРИСТАЛІЧНА ФОРМА (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНІЛ)-ПІРОЛІДИН-1-ІЛ)-ПІРАЗОЛО[1,5-a]ПІРИМІДИН-3-ІЛ)-3-ГІДРОКСИПІРОЛІДИН-1-КАРБОКСАМІД ГІДРОСУЛЬФАТУ (CRYSTALLINE FORM OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE HYDROGEN SULFATE) See Plans and Pricing
Poland 3372605 See Plans and Pricing
Lithuania 3372605 See Plans and Pricing
China 107428760 (S)‑N‑(5‑((R)‑2‑(2,5‑二氟苯基)‑吡咯烷‑1‑基)‑吡唑并[1,5‑A]嘧啶‑3‑基)‑3‑羟基吡咯烷‑1‑甲酰胺硫酸氢盐的晶型 (CRYSTALLINE FORM OF (s)-n-(5-((r)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VITRAKVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3106463 PA2020504 Lithuania See Plans and Pricing PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463 C20200005 00308 Estonia See Plans and Pricing PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
3106463 LUC00150 Luxembourg See Plans and Pricing PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SULFATE DE LAROTRECTINIB, Y COMPRIS L'HYDROGENOSULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463 132020000000025 Italy See Plans and Pricing PRODUCT NAME: LAROTRECTINIB E/O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE LAROTRECTINIB SOLFATO INCLUSO LAROTRECTINIB IDROGENO SOLFATO(VITRAKVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1385, 20190923
3106463 C202030011 Spain See Plans and Pricing PRODUCT NAME: LAROTRECTINIB Y/O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PARTICULARMENTE SULFATO DE LAROTRECTINIB QUE INCLUYE HIDROGENOSULFATO DE LAROTRECTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF AUTHORISATION: 20190919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1385; DATE OF FIRST AUTHORISATION IN EEA: 20190919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Baxter
Merck
Johnson and Johnson
AstraZeneca

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.