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Last Updated: July 18, 2024

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VITRAKVI Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Vitrakvi

Vitrakvi was eligible for patent challenges on November 26, 2022.

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:212
US Patents:18
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 91
Clinical Trials: 5
Patent Applications: 165
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 Loss of Exclusivity (LOE) 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
Bristol-Myers SquibbPhase 2

See all VITRAKVI clinical trials

Pharmacology for VITRAKVI

US Patents and Regulatory Information for VITRAKVI

VITRAKVI is protected by nineteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VITRAKVI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LUNG CANCER, UNDIFFERENTIATED SARCOMA, OR COLORECTAL CANCER THAT EXHIBITS AN NTRK GENE FUSION

Methods of treating pediatric cancers
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK FUSION GENE IN A PEDIATRIC PATIENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors
Patent Number: ⤷  Sign Up
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Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING CANCEROUS SOLID TUMORS

Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15346046
Patent: 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
Estimated Expiration: ⤷  Sign Up

Patent: 17246547
Estimated Expiration: ⤷  Sign Up

Patent: 17246554
Patent: Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017010141
Patent: forma cristalina de hidrogenossulfato de (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3-hidroxipirrolidina-1-carboxamida
Estimated Expiration: ⤷  Sign Up

Patent: 2018070017
Patent: métodos de tratamento de cânceres pediátricos
Estimated Expiration: ⤷  Sign Up

Patent: 2018070304
Patent: formulações líquidas de (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3-hidroxipirrolidina-1-carboxamida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 67951
Patent: FORME CRISTALLINE D'HYDROGENOSULFATE DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (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)
Estimated Expiration: ⤷  Sign Up

Patent: 19661
Patent: METHODES DE TRAITEMENT DE CANCERS PEDIATRIQUES (METHODS OF TREATING PEDIATRIC CANCERS)
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Patent: 19671
Patent: FORMULATIONS LIQUIDES DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17001249
Patent: Forma cristalina de sulfato de hidrógeno (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidinaa-1-il)-pirazolo[1,5-a] pirimidinaa-3-il)-3-hidroxipirrolidinaa-1-carboxamida.
Estimated Expiration: ⤷  Sign Up

Patent: 18002806
Patent: Formulaciones líquidas de (s)-n-(5-((r)-2-(2,5-difluorofenil) -pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3-hidroxipirrolidina-1-carboxamida.
Estimated Expiration: ⤷  Sign Up

Patent: 18002807
Patent: Métodos de tratamiento de cánceres pediátricos.
Estimated Expiration: ⤷  Sign Up

Patent: 19002238
Patent: Formulaciones liquidas de (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3 hidroxipirrolidina -1-carboxamida. (divisional solicitud 201802806)
Estimated Expiration: ⤷  Sign Up

Patent: 19002239
Patent: Métodos de tratamiento de cánceres pediátricos. (divisional solicitud 201802807)
Estimated Expiration: ⤷  Sign Up

China

Patent: 7428760
Estimated Expiration: ⤷  Sign Up

Patent: 9310694
Patent: 治疗儿科癌症的方法 (METHODS OF TREATING PEDIATRIC CANCERS)
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Patent: 9414442
Estimated Expiration: ⤷  Sign Up

Patent: 3354649
Patent: 一种新的晶型 (Novel crystalline form)
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Colombia

Patent: 17005483
Patent: Forma cristalina de sulfato de hidrógeno de (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidin-1- il)-pirazol[1,5-a]pirimidin-3-il)-3-hidroxipirrolidina-1-carboxamida
Estimated Expiration: ⤷  Sign Up

Patent: 18010761
Patent: Formulaciones líquidas de (s)-n-(5-((r)-2-(2,5-difluorofenil) -pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3-hidroxipirrolidina-1-carboxamida
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Costa Rica

Patent: 170263
Patent: FORMA CRISTALINA DE SULFATO ACIDO DE (S)-N- (5- ( (R)-2- (2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]-PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Estimated Expiration: ⤷  Sign Up

Patent: 180501
Patent: FORMULACIONES LIQUIDAS DE (S)-N-(5-((R)-2(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A] PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0230271
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 180125
Patent: FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL) -PIRROLIDIN-1-IL)-PIRAZOLO[1,5-ALPIRIMIDIN-3-IL)-3 HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 99181
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 018000214
Patent: FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL) -PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 18083443
Patent: FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL) -PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 18380
Patent: FORME CRISTALLINE D'HYDROGÉNOSULFATE DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (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)
Estimated Expiration: ⤷  Sign Up

Patent: 39662
Patent: FORMULATIONS LIQUIDES DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

Patent: 39663
Patent: MÉTHODES DE TRAITEMENT DE CANCERS PÉDIATRIQUES (METHODS OF TREATING PEDIATRIC CANCERS)
Estimated Expiration: ⤷  Sign Up

Patent: 99181
Patent: FORME CRISTALLINE D'HYDROGÉNOSULFATE DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (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)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 99181
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0227339
Patent: LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)- PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDRO-XYPYRROLIDINE-1-CARBOXAMIDE
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 44483
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 61448
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2270
Patent: צורה גבישית של (s)-n-(5-)-2-(r)) 5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד מימן סולפאט (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)
Estimated Expiration: ⤷  Sign Up

Patent: 2003
Patent: פורמולציות נוזליות של (s)-n-(5-((r)-2-(5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד (Liquid formulations of (s)-n-(5-((r)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide)
Estimated Expiration: ⤷  Sign Up

Patent: 2005
Patent: שיטות לטיפול בסרטן בילדים (Methods of treating pediatric cancers)
Estimated Expiration: ⤷  Sign Up

Patent: 0905
Patent: צורה גבישית של (s)-n-(5-)-2-(r)) 5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד מימן סולפאט (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)
Estimated Expiration: ⤷  Sign Up

Patent: 4018
Patent: פורמולציות נוזליות של (s)-n-(5-((r)-2-(5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד (Liquid formulations of (s)-n-(5-((r)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 14834
Estimated Expiration: ⤷  Sign Up

Patent: 57343
Estimated Expiration: ⤷  Sign Up

Patent: 61602
Estimated Expiration: ⤷  Sign Up

Patent: 17535550
Patent: (S)−N−(5−((R)−2−(2,5−ジフルオロフェニル)−ピロリジン−1−イル)−ピラゾロ[1,5−a]ピリミジン−3−イル)−3−ヒドロキシピロリジン−1−カルボキサミド硫酸水素塩の結晶形
Estimated Expiration: ⤷  Sign Up

Patent: 19510827
Patent: 小児癌の処置方法
Estimated Expiration: ⤷  Sign Up

Patent: 19511575
Patent: (S)−N−(5−((R)−2−(2,5−ジフルオロフェニル)−ピロリジン−1−イル)−ピラゾロ[1,5−a]ピリミジン−3−イル)−3−ヒドロキシピロリジン−1−カルボキサミドの液体製剤
Estimated Expiration: ⤷  Sign Up

Patent: 21169496
Patent: (S)−N−(5−((R)−2−(2,5−ジフルオロフェニル)−ピロリジン−1−イル)−ピラゾロ[1,5−a]ピリミジン−3−イル)−3−ヒドロキシピロリジン−1−カルボキサミド硫酸水素塩の結晶形 (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)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 99181
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17006412
Patent: FORMA CRISTALINA DE SULFATO ACIDO DE (S)-N-(5-((R)-2-(2,5-DIFLUORO FENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]-PIRIMIDIN-3-IL)-3-HIDROXI PIRROLIDINA-1-CARBOXAMIDA. (CRYSTALLINE FORM OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLID IN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-C ARBOXAMIDE HYDROGEN SULFATE.)
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Patent: 18012163
Patent: FORMULACIONES LIQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRR OLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA- 1-CARBOXAMIDA. (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRRO LIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE- 1-CARBOXAMIDE.)
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Patent: 18012165
Patent: METODOS DE TRATAMIENTO DE CANCERES PEDIATRICOS. (METHODS OF TREATING PEDIATRIC CANCERS.)
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Patent: 20011079
Patent: FORMA CRISTALINA DE SULFATO ACIDO DE (S)-N-(5-((R)-2-(2,5-DIFLUORO FENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]-PIRIMIDIN-3-IL)-3-HIDROXI PIRROLIDINA-1-CARBOXAMIDA. (CRYSTALLINE FORM OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLID IN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-C ARBOXAMIDE HYDROGEN SULFATE.)
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Morocco

Patent: 601
Patent: Formulations liquides de (s)-n-(5-((r)-2-(2,5-difluorophényl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
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Patent: 610
Patent: FORMULATIONS LIQUIDES DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE
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Patent: 612
Patent: MÉTHODES DE TRAITEMENT DE CANCERS PÉDIATRIQUES
Estimated Expiration: ⤷  Sign Up

Patent: 504
Patent: Forme cristalline d'hydrogénosulfate de (s)-n-(5-((r)-2-(2,5-difluorophényl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
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New Zealand

Patent: 1909
Patent: 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
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Nicaragua

Patent: 1800102
Patent: FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1, 5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA.
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Peru

Patent: 181888
Patent: FORMULACIONES LIQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
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Philippines

Patent: 017500900
Patent: 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
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Patent: 018502124
Patent: LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE
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Patent: 018502134
Patent: METHODS OF TREATING PEDIATRIC CANCERS
Estimated Expiration: ⤷  Sign Up

Patent: 021550809
Patent: 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
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Poland

Patent: 99181
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 99181
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 23990
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНИЛ)-ПИРРОЛИДИН-1-ИЛ)-ПИРАЗОЛО[1,5-A]ПИРИМИДИН-3-ИЛ)-3-ГИДРОКСИПИРРОЛИДИН-1-КАРБОКСАМИДА ГИДРОСУЛЬФАТА (CRYSTALLINE FORM (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE HYDROSULPHATE)
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Patent: 51636
Patent: СПОСОБЫ ЛЕЧЕНИЯ ДЕТСКИХ РАКОВЫХ ЗАБОЛЕВАНИЙ (METHODS FOR TREATMENT OF CHILDHOOD CANCER DISEASES)
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Patent: 51767
Patent: ЖИДКИЕ СОСТАВЫ (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНИЛ)ПИРРОЛИДИН-1-ИЛ)ПИРАЗОЛО[1,5-A]ПИРИМИДИН-3-ИЛ)-3-ГИДРОКСИПИРРОЛИДИН-1-КАРБОКСАМИДА (LIQUID COMPOSITIONS (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)PYRROLIDINE-1-YL)PYRAZOLO[1,5-A]PYRIMIDINE-3-YL)-3-HYDROXYPYRROLIDINE-1-ARBOXAMIDE)
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Patent: 17120846
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНИЛ)-ПИРОЛИДИН-1-ИЛ)-ПИРАЗОЛО[1,5-A]ПИРИМИДИН-3-ИЛ)-3-ГИДРОКСИПИРРОЛИДИН-1-КАРБОКСАМИДА ГИДРОСУЛЬФАТА
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Patent: 18137206
Patent: ЖИДКИЕ СОСТАВЫ (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНИЛ)ПИРРОЛИДИН-1-ИЛ)ПИРАЗОЛО[1,5-A]ПИРИМИДИН-3-ИЛ)-3-ГИДРОКСИПИРРОЛИДИН-1-КАРБОКСАМИДА
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Patent: 18138579
Patent: СПОСОБЫ ЛЕЧЕНИЯ ДЕТСКИХ РАКОВЫХ ЗАБОЛЕВАНИЙ
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Saudi Arabia

Patent: 8400168
Patent: صيغ سائلة من (S)-N-(5-((R)-2-(2، 5-داي فلورو فينيل)-بيروليدين-1-يل)-بيرازولو[1، 5-A] بيريميدين-3-يل)-3-هيدروكسي بيروليدين-1-كربوكساميد (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
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Serbia

Patent: 122
Patent: KRISTALNI OBLIK (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROKSIPIROLIDIN-1-KARBOKSAMID HIDROGENSULFATA (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)
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Singapore

Patent: 201703962X
Patent: 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
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Patent: 201808559P
Patent: LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE
Estimated Expiration: ⤷  Sign Up

Patent: 201808676R
Patent: METHODS OF TREATING PEDIATRIC CANCERS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 99181
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1703501
Patent: 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
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South Korea

Patent: 2400423
Estimated Expiration: ⤷  Sign Up

Patent: 2649887
Estimated Expiration: ⤷  Sign Up

Patent: 170082628
Estimated Expiration: ⤷  Sign Up

Patent: 180128484
Estimated Expiration: ⤷  Sign Up

Patent: 180129911
Patent: 소아암을 치료하는 방법
Estimated Expiration: ⤷  Sign Up

Patent: 210010652
Patent: 소아암을 치료하는 방법 (METHODS OF TREATING PEDIATRIC CANCERS)
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Spain

Patent: 41630
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 46426
Estimated Expiration: ⤷  Sign Up

Patent: 46537
Estimated Expiration: ⤷  Sign Up

Patent: 67858
Estimated Expiration: ⤷  Sign Up

Patent: 1625636
Patent: 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
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Patent: 1801730
Patent: Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
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Patent: 2206436
Patent: 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
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 18000335
Patent: LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE
Estimated Expiration: ⤷  Sign Up

Patent: 18000338
Patent: METHODS OF TREATING PEDIATRIC CANCERS
Estimated Expiration: ⤷  Sign Up

Patent: 19000332
Patent: METHODS OF TREATING PEDIATRIC CANCERS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 3044
Patent: 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)
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Patent: 5025
Patent: СПОСОБИ ЛІКУВАННЯ ДИТЯЧИХ РАКОВИХ ЗАХВОРЮВАНЬ (METHODS OF TREATING PEDIATRIC CANCERS)
Estimated Expiration: ⤷  Sign Up

Patent: 5026
Patent: РІДКІ КОМПОЗИЦІЇ (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНІЛ)ПІРОЛІДИН-1-ІЛ)ПІРАЗОЛО[1,5-a]ПІРИМІДИН-3-ІЛ)-3-ГІДРОКСИПІРОЛІДИН-1-КАРБОКСАМІДУ (LIQUID FORMULATIONS OF (S)-N-(5-(R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

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
Japan 2015214590 TRKキナーゼ阻害剤としての置換ピラゾロ[1,5−a]ピリミジン化合物 (SUBSTITUTED PYRAZOLO[1,5-a]PYRIMIDINE COMPOUND AS TRK KINASE INHIBITOR) ⤷  Sign Up
Ecuador SP18083443 FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL) -PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA ⤷  Sign Up
South Korea 20140129384 SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS ⤷  Sign Up
Israel 290905 צורה גבישית של (s)-n-(5-)-2-(r)) 5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד מימן סולפאט (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) ⤷  Sign Up
Turkey 201807039 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VITRAKVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3106463 11/2020 Austria ⤷  Sign Up PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463 2090009-8 Sweden ⤷  Sign Up PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
3106463 122020000012 Germany ⤷  Sign Up PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463 C202030011 Spain ⤷  Sign Up 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
3106463 C03106463/01 Switzerland ⤷  Sign Up PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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