VITRAKVI Drug Patent Profile
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Which patents cover Vitrakvi, and when can generic versions of Vitrakvi launch?
Vitrakvi is a drug marketed by Bayer Hlthcare and Bayer Healthcare and is included in two NDAs. There are eighteen patents protecting this drug.
This drug has two hundred and twenty-three patent family members in fifty countries.
The generic ingredient in VITRAKVI is larotrectinib sulfate. Two suppliers are listed for this compound. Additional details are available on the larotrectinib sulfate profile page.
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: | 223 |
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 |
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
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
Children's Oncology Group | Phase 2 |
Merck Sharp & Dohme Corp. | Phase 2 |
Pharmacology for VITRAKVI
Drug Class | Kinase Inhibitor |
Mechanism of Action | Tropomyosin Receptor Kinases Inhibitors |
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
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 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)
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
Patent: 9414442
Estimated Expiration: ⤷ Sign Up
Patent: 3354649
Patent: 一种新的晶型 (Novel crystalline form)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
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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
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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
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Patent: 201808676R
Patent: METHODS OF TREATING PEDIATRIC CANCERS
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Slovenia
Patent: 99181
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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
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Patent: 180128484
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Patent: 180129911
Patent: 소아암을 치료하는 방법
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Patent: 210010652
Patent: 소아암을 치료하는 방법 (METHODS OF TREATING PEDIATRIC CANCERS)
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Spain
Patent: 41630
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Taiwan
Patent: 46426
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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
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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
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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)
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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)
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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 |
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Singapore | 11201703962X | 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 |
Taiwan | I458729 | ⤷ Sign Up | |
Philippines | 12018502124 | 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 | ⤷ Sign Up |
Costa Rica | 20180501 | 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) | ⤷ Sign Up |
Morocco | 44612 | MÉTHODES DE TRAITEMENT DE CANCERS PÉDIATRIQUES | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VITRAKVI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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3106463 | 2020/009 | Ireland | ⤷ Sign Up | PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; 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 | 2020C/507 | Belgium | ⤷ Sign Up | PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923 |
3106463 | 132020000000025 | Italy | ⤷ Sign Up | 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 | PA2020504 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |