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McKinsey
Cipla
Mallinckrodt
Chubb
Cantor Fitzgerald
US Army

Generated: May 21, 2019

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ZEJULA Drug Profile

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Which patents cover Zejula, and when can generic versions of Zejula launch?

Zejula is a drug marketed by Tesaro Inc and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-three patent family members in forty-four countries.

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

Summary for ZEJULA
Drug patent expirations by year for ZEJULA
Generic Entry Opportunity Date for ZEJULA
Generic Entry Date for ZEJULA*:
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.

Pharmacology for ZEJULA
Synonyms for ZEJULA
(S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide
0919AA
1038915-60-4
1038915-60-4 pound notMK4827 pound not MK 4827
2-[4-[(3S)-3-Piperidyl]phenyl]indazole-7-carboxamide
2-[4-[(3S)-piperidin-3-yl]phenyl]indazole-7-carboxamide
2-{4-[(3s)-piperidin-3-yl]phenyl}-2h-indazole-7-carboxamide
2-{4-[(3S)-piperidin-3-yl]phenyl}indazole-7-carboxamide
2H-Indazole-7-carboxamide, 2-[4-(3S)-3-piperidinylphenyl]-
A3617
AC-28447
AJ-108285
AK102507
AKOS016004869
ANW-62065
AS-35248
AX8234046
BCP0726000077
BCP9000940
BDBM50316226
CHEMBL1094636
compound 56 [PMID 19873981]
CS-0780
CTK8B9123
D10140
DB-059068
DB11793
DTXSID50146129
EX-A290
FT-0770704
GTPL8275
HMC2H89N35
HY-10619
KB-03718
MK 4827
MK 4827 (Base)
MK-4827
MK-4827,(S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxaMide
MK-4827(Niraparib)
MK-4827/MK4827
MK4827
MolPort-023-219-142
NCGC00346435-01
NCGC00346435-04
Niraparib
Niraparib (USAN)
Niraparib [USAN:INN]
s2741
SB16547
SCHEMBL1421875
TC-150810
UNII-HMC2H89N35
W-5696
Zejula (TN)
ZINC43206370

US Patents and Regulatory Information for ZEJULA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Supplementary Protection Certificates for ZEJULA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 PA2018009 Lithuania ➤ Try a Free Trial PRODUCT NAME: NIRAPAARIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, STEREOIZOMERAS ARBA TAUTOMERAS, BUTENT TOSILATAS ARBA HIDRATAS, YPATINGAI TOSILATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 CA 2018 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
2109608 122018000048 Germany ➤ Try a Free Trial PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 1890020-9 Sweden ➤ Try a Free Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
2109608 2018C/017 Belgium ➤ Try a Free Trial PRODUCT NAME: NIRAPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, STEREOISOMEER OF TAUTOMEER, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120
2109608 C201830023 Spain ➤ Try a Free Trial PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
McKesson
UBS
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Merck

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