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 sixteen patents protecting this drug.

This drug has two hundred and two 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:	202
US Patents:	16
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	5
Patent Applications:	235
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VITRAKVI

Generic Entry Dates for VITRAKVI^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 210861 Dosage: CAPSULE;ORAL
Generic Entry Dates for VITRAKVI^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 211710 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
Bristol-Myers Squibb	Phase 2

See all VITRAKVI clinical trials

Pharmacology for VITRAKVI

Drug Class	Kinase Inhibitor
Mechanism of Action	Tropomyosin Receptor Kinases Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VITRAKVI

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CANCEROUS SOLID TUMORS

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

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

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: ⤷ Try a Trial

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: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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: ⤷ Try a Trial

Australia

Patent: 15346046
Estimated Expiration: ⤷ Try a Trial

Patent: 17246547
Estimated Expiration: ⤷ Try a Trial

Patent: 17246554
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2017010141
Estimated Expiration: ⤷ Try a Trial

Patent: 2018070017
Estimated Expiration: ⤷ Try a Trial

Patent: 2018070304
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 67951
Estimated Expiration: ⤷ Try a Trial

Patent: 19661
Estimated Expiration: ⤷ Try a Trial

Patent: 19671
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 17001249
Estimated Expiration: ⤷ Try a Trial

Patent: 18002806
Estimated Expiration: ⤷ Try a Trial

Patent: 18002807
Estimated Expiration: ⤷ Try a Trial

Patent: 19002238
Estimated Expiration: ⤷ Try a Trial

Patent: 19002239
Estimated Expiration: ⤷ Try a Trial

China

Patent: 7428760
Estimated Expiration: ⤷ Try a Trial

Patent: 9310694
Estimated Expiration: ⤷ Try a Trial

Patent: 9414442
Estimated Expiration: ⤷ Try a Trial

Patent: 3354649
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 17005483
Estimated Expiration: ⤷ Try a Trial

Patent: 18010761
Estimated Expiration: ⤷ Try a Trial

Costa Rica

Patent: 170263
Estimated Expiration: ⤷ Try a Trial

Patent: 180501
Estimated Expiration: ⤷ Try a Trial

Cuba

Patent: 180125
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 99181
Estimated Expiration: ⤷ Try a Trial

Dominican Republic

Patent: 018000214
Estimated Expiration: ⤷ Try a Trial

Ecuador

Patent: 18083443
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 18380
Estimated Expiration: ⤷ Try a Trial

Patent: 39662
Estimated Expiration: ⤷ Try a Trial

Patent: 39663
Estimated Expiration: ⤷ Try a Trial

Patent: 99181
Estimated Expiration: ⤷ Try a Trial

Finland

Patent: 99181
Estimated Expiration: ⤷ Try a Trial

Georgia, Republic of

Patent: 0227339
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 44483
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 2270
Estimated Expiration: ⤷ Try a Trial

Patent: 2003
Estimated Expiration: ⤷ Try a Trial

Patent: 2005
Estimated Expiration: ⤷ Try a Trial

Patent: 0905
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 14834
Estimated Expiration: ⤷ Try a Trial

Patent: 57343
Estimated Expiration: ⤷ Try a Trial

Patent: 61602
Estimated Expiration: ⤷ Try a Trial

Patent: 17535550
Estimated Expiration: ⤷ Try a Trial

Patent: 19510827
Estimated Expiration: ⤷ Try a Trial

Patent: 19511575
Estimated Expiration: ⤷ Try a Trial

Patent: 21169496
Estimated Expiration: ⤷ Try a Trial

Lithuania

Patent: 99181
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 17006412
Estimated Expiration: ⤷ Try a Trial

Patent: 18012163
Estimated Expiration: ⤷ Try a Trial

Patent: 18012165
Estimated Expiration: ⤷ Try a Trial

Patent: 20011079
Estimated Expiration: ⤷ Try a Trial

Morocco

Patent: 601
Estimated Expiration: ⤷ Try a Trial

Patent: 610
Estimated Expiration: ⤷ Try a Trial

Patent: 612
Estimated Expiration: ⤷ Try a Trial

Patent: 504
Estimated Expiration: ⤷ Try a Trial

Nicaragua

Patent: 1800102
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 181888
Estimated Expiration: ⤷ Try a Trial

Philippines

Patent: 017500900
Estimated Expiration: ⤷ Try a Trial

Patent: 018502124
Estimated Expiration: ⤷ Try a Trial

Patent: 018502134
Estimated Expiration: ⤷ Try a Trial

Patent: 021550809
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 99181
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 23990
Estimated Expiration: ⤷ Try a Trial

Patent: 51636
Estimated Expiration: ⤷ Try a Trial

Patent: 51767
Estimated Expiration: ⤷ Try a Trial

Patent: 17120846
Estimated Expiration: ⤷ Try a Trial

Patent: 18137206
Estimated Expiration: ⤷ Try a Trial

Patent: 18138579
Estimated Expiration: ⤷ Try a Trial

Saudi Arabia

Patent: 8400168
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 201703962X
Estimated Expiration: ⤷ Try a Trial

Patent: 201808559P
Estimated Expiration: ⤷ Try a Trial

Patent: 201808676R
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 1703501
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 2400423
Estimated Expiration: ⤷ Try a Trial

Patent: 170082628
Estimated Expiration: ⤷ Try a Trial

Patent: 180128484
Estimated Expiration: ⤷ Try a Trial

Patent: 180129911
Estimated Expiration: ⤷ Try a Trial

Patent: 210010652
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 46426
Estimated Expiration: ⤷ Try a Trial

Patent: 46537
Estimated Expiration: ⤷ Try a Trial

Patent: 67858
Estimated Expiration: ⤷ Try a Trial

Patent: 1625636
Estimated Expiration: ⤷ Try a Trial

Patent: 1801730
Estimated Expiration: ⤷ Try a Trial

Patent: 2206436
Estimated Expiration: ⤷ Try a Trial

Tunisia

Patent: 18000335
Estimated Expiration: ⤷ Try a Trial

Patent: 18000338
Estimated Expiration: ⤷ Try a Trial

Patent: 19000332
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 3044
Estimated Expiration: ⤷ Try a Trial

Patent: 5025
Estimated Expiration: ⤷ Try a Trial

Patent: 5026
Estimated Expiration: ⤷ Try a Trial

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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
China	103509017	Substituted pyrazolo[1,5-a]pyrimidine compounds as TRK kinase inhibitors	⤷ Try a Trial
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)	⤷ Try a Trial
Slovenia	2725028		⤷ Try a Trial
Japan	2019510827	小児癌の処置方法	⤷ Try a Trial
Ukraine	125025	СПОСОБИ ЛІКУВАННЯ ДИТЯЧИХ РАКОВИХ ЗАХВОРЮВАНЬ (METHODS OF TREATING PEDIATRIC CANCERS)	⤷ Try a Trial
Chile	2018002806	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.	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VITRAKVI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	132020000000025	Italy	⤷ Try a Trial	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	122020000012	Germany	⤷ Try a Trial	PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463	PA2020504,C3106463	Lithuania	⤷ Try a Trial	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	CR 2020 00013	Denmark	⤷ Try a Trial	PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463	301033	Netherlands	⤷ Try a Trial	PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	C03106463/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description