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Last Updated: January 28, 2020

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ERLEADA Drug Profile

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When do Erleada patents expire, and what generic alternatives are available?

Erleada is a drug marketed by Janssen Biotech and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and sixty patent family members in thirty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Erleada

Erleada will be eligible for patent challenges on February 14, 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 June 4, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ERLEADA
Drug Prices for ERLEADA

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Generic Entry Opportunity Date for ERLEADA
Generic Entry Date for ERLEADA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 ERLEADA

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
NRG OncologyPhase 3

See all ERLEADA clinical trials

Recent Litigation for ERLEADA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Degui Chen v. Michael E. Jung2018-03-12

See all ERLEADA litigation

Synonyms for ERLEADA
1361232-32-7
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro(3.4)octan-5-yl)-2-fluoro-N-methylbenzamide
4-(7-(6-CYANO-5-(TRIFLUOROMETHYL)PYRIDIN-3-YL)-8-OXO-6-THIOXO-5,7-DIAZASPIRO[3.4]OCTAN-5-YL)-2-FLUORO-N-METHYLBENZAMIDE
4-(7-(6-cyano-5-(trifluoroMethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspirooctan-5-yl)-2-fluoro-N-MethylbenzaMide
4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-benzamide
4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide
4-{7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl}-2-fluoro-N-methylbenzamide
4T36H88UA7
956104-40-8
AB0008189
ABP001022
AC-27403
ACN-031562
AK174739
AKOS025401932
AMX10207
apalutamide
Apalutamide (JAN/INN)
Apalutamide [INN]
Apalutamide pound ARN509 pound(c)
AR509
AR509/AR-509
ARN 509
ARN-509
ARN509
AS-35181
BC600521
BCP05829
BDBM50094975
C21H15F4N5O2S
CHEMBL3183409
CS-0885
D11040
DB11901
DTXSID40241899
Erleada (TN)
EX-A089
GTPL9043
HJBWBFZLDZWPHF-UHFFFAOYSA-N
HMS3656N12
HY-16060
J-519596
JNJ 56021927
JNJ-56021927
KB-74733
KS-00000SN8
MLS006011109
MolPort-027-720-961
NCGC00346725-01
NCGC00346725-06
PB27306
QCR-211
RL06020
s2840
SCHEMBL909297
SMR004702891
SW220300-1
Tube705
UNII-4T36H88UA7
W-5908
Y0375
ZINC43174901

US Patents and Regulatory Information for ERLEADA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   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 ERLEADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 LUC00123 Luxembourg   Start Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550 2019C/529 Belgium   Start Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550 CR 2019 00029 Denmark   Start Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck

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