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Harvard Business School

Last Updated: January 24, 2020

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VITRAKVI Drug Profile

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US ANDA Litigation and 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 November 16, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VITRAKVI
International Patents:136
US Patents:12
Applicants:2
NDAs:2
Suppliers / Packagers: 2
Bulk Api Vendors: 22
Patent Applications: 27
Drug Prices: Drug price information for VITRAKVI
DailyMed Link:VITRAKVI at DailyMed
Drug patent expirations by year for VITRAKVI
Drug Prices for VITRAKVI

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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.

Synonyms for VITRAKVI
(3S)-N-(5-((2R)-2-(2,5-Difluorophenyl)pyrrolidin-1-yl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxypyrrolidine- 1-carboxamide
(3S)-N-[5-[(2R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxypyrrolidine-1-carboxamide
(S)-N-(5 -((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin -1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3 yl)-3-hydroxypyrrolidine-1-carboxamide
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
1-Pyrrolidinecarboxamide, N-(5-((2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxy-, (3S)-
1-Pyrrolidinecarboxamide, N-[5-[(2R)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3S)-
1223403-58-4
ARRY 470
ARRY-470
ARRY-470; larotrectinib
ARRY470
ARRY470;ARRY-470;ARRY 470;LOXO 101;LOXO101;Larotrectinib
AS-35231
BCP16262
BDBM136597
CHEMBL3889654
CS-5722
D11137
EX-A1981
example 14 [US8865698 B2]
GTPL8909
HY-12866
J3.628.138C
Larotrectinib
Larotrectinib (USAN/INN)
Larotrectinib [USAN:INN]
LOXO 101
LOXO-101
LOXO101
MFCD28902192
NYNZQNWKBKUAII-KBXCAEBGSA-N
PF9462I9HX
Q27081513
SCHEMBL2241012
UNII-PF9462I9HX
US8865698, 14
ZINC118399834

US Patents and Regulatory Information for VITRAKVI

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

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Harvard Business School
Express Scripts
Medtronic
McKinsey

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 verifification 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.