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Last Updated: April 9, 2020

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ROZLYTREK Drug Profile


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Which patents cover Rozlytrek, and what generic alternatives are available?

Rozlytrek is a drug marketed by Genentech Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has eighty patent family members in twenty-seven countries.

The generic ingredient in ROZLYTREK is entrectinib. One supplier is listed for this compound. Additional details are available on the entrectinib profile page.

US ANDA Litigation and Generic Entry Outlook for Rozlytrek

Rozlytrek will be eligible for patent challenges on August 15, 2023. 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 July 18, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ROZLYTREK
Drug patent expirations by year for ROZLYTREK
Drug Prices for ROZLYTREK

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Generic Entry Opportunity Date for ROZLYTREK
Generic Entry Date for ROZLYTREK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 ROZLYTREK

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

SponsorPhase
Hoffmann-La RochePhase 1

See all ROZLYTREK clinical trials

Synonyms for ROZLYTREK
1108743-60-7
AK547001
B5859
BCP16174
Benzamide, N-(5-((3,5-difluorophenyl)methyl)-1H-indazol-3-yl)-4-(4-methyl-1-piperazinyl)-2-((tetrahydro-2H-pyran-4-yl)amino)-
Benzamide, N-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methyl-1-piperazinyl)-2-[(tetrahydro-2H-pyran-4-yl)amino]-
CHEMBL1983268
D10926
DA-47850
DB11986
Entrectinib
Entrectinib (JAN/USAN/INN)
Entrectinib (RXDX-101)
Entrectinib [USAN:INN]
entrectinib-rxdx-101
Entrectinib, 95%
Entrectinib; NMS-E628
Entrectinib(rxdx-101)
EX-A2261
FT-0736318
GTPL8290
HAYYBYPASCDWEQ-UHFFFAOYSA-N
HY-12678
Kinome_2659
KS-00000TSK
L5ORF0AN1I
MFCD28129099
N-(5-(3,5-difluorobenzyl)-1H-indazol-3-yl)-4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide
N-(5-(3,5-Difluorobenzyl)-1H-indazol-3-yl)-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide
N-[5-(3,5-Difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
N-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(oxan-4-ylamino)benzamide
N-{5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide
N-{5-[(3,5-difluorophenyl)methyl]-3H-indazol-3-ylidene}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide
NCGC00484067-01
NCGC00484067-03
NMS-E-628
NMS-E628
RXDX-101
s7998
S900006830
SB17194
SCHEMBL3512601
UNII-L5ORF0AN1I
YMX
ZINC43204146

US Patents and Regulatory Information for ROZLYTREK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 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:

Merck
Express Scripts
AstraZeneca
Boehringer Ingelheim
Moodys
Colorcon

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.