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Last Updated: April 10, 2020

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ZEJULA Drug Profile


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When do Zejula patents expire, and when can generic versions of Zejula launch?

Zejula is a drug marketed by Glaxosmithkline and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and thirty-nine patent family members in forty-nine 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.

US ANDA Litigation and Generic Entry Outlook for Zejula

Zejula will be eligible for patent challenges on March 27, 2021. 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 March 22, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

See drug prices 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.

Recent Clinical Trials for ZEJULA

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

SponsorPhase
Emory UniversityPhase 2
GlaxoSmithKlinePhase 2
MedSIRPhase 2

See all ZEJULA clinical trials

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-Piperidinylphenyl]-2H-indazole-7-carboxamide
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
2H-Indazole-7-carboxamide, 2-[4-(3S)-3-piperidinylphenyl]-
A11026
A3617
AC-28447
AKOS016004869
ANW-62065
AS-35248
AX8234046
BCP0726000077
BCP9000940
BDBM50316226
CHEMBL1094636
compound 56 [PMID 19873981]
CS-0780
CTK8B9123
D10140
DB11793
DTXSID50146129
EX-A290
FT-0770704
GTPL8275
HMC2H89N35
HY-10619
JNJ-64091742
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
NCGC00346435-01
NCGC00346435-04
Niraparib
Niraparib (MK-4827)
Niraparib (USAN)
Niraparib [USAN:INN]
Q25326660
s2741
SB16547
SCHEMBL1421875
TC-150810
UNII-HMC2H89N35
W-5696
Zejula (TN)
ZINC43206370
ZL-2306

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
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 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

Supplementary Protection Certificates for ZEJULA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 S1500012 Hungary   Start Trial PRODUCT NAME: OLAPARIB
2109608 18C1019 France   Start Trial PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
1633724 596 Finland   Start Trial
2109608 2018C/017 Belgium   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Express Scripts
Colorcon
Mallinckrodt
Moodys

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.