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Last Updated: February 29, 2020

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JARDIANCE Drug Profile


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

Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-two patent family members in forty-four countries.

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.

US ANDA Litigation and Generic Entry Outlook for Jardiance

Jardiance was eligible for patent challenges on August 1, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 14, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $1.4bn, indicating a strong incentive for generic entry.

There have been three 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 JARDIANCE
Drug Prices for JARDIANCE

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Drug Sales Revenue Trends for JARDIANCE

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Generic Entry Opportunity Date for JARDIANCE
Generic Entry Date for JARDIANCE*:
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 JARDIANCE

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

SponsorPhase
VU University Medical CenterPhase 4
Mario Negri Institute for Pharmacological ResearchPhase 2
Centro Universitario de Ciencias de la Salud, MexicoPhase 3

See all JARDIANCE clinical trials

Recent Litigation for JARDIANCE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited2018-11-08

See all JARDIANCE litigation

Pharmacology for JARDIANCE
Synonyms for JARDIANCE
(1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol
(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol
(1S)-1,5-anhydro-1-C-{4-chloro-3-((4-{((3S)-oxolan-3-yl)oxy}phenyl)methyl)phenyl}-D-glucitol
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-chloro-3-({4-[(3S)-oxolan-3-yloxy]phenyl}methyl)phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
(2S,3R,4R,5S,6R)-2-[4-CHLORO-3-[[4-[(3S)-OXOLAN-3-YL]OXYPHENYL]METHYL]PHENYL]-6-(HYDROXYMETHYL)OXANE-3,4,5-TRIOL
(2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-tetrahydrofuran-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol
(S)-Empagliflozin D4
1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene
1314556-33-6
4CH-023469
864070-44-0
AC-27643
AJ-93046
AK160980
AKOS024464680
AX8293990
BBL104150
BC600492
BDBM150162
BI 10773
BI-10773
BI-10773;Empagliflozin
BI10773
C23H27ClO7
CE0108
CHEBI:82720
CHEMBL2107830
CS-0940
D10459
DB09038
DS-9824
Empagliflozin
Empagliflozin (BI-10773;BI 10773;BI10773)
Empagliflozin (BI 10773)
Empagliflozin (BI10773)
Empagliflozin (JAN/USAN/INN)
Empagliflozin [USAN:INN]
EX-A414
GTPL4754
HDC1R2M35U
HY-15409
Jardiance (TN)
KB-76792
KS-0000072W
MolPort-027-720-828
PB23119
Q-4526
s8022
SC-15843
SCHEMBL899986
ST24046679
STL557964
SW219120-1
Tube106
UNII-HDC1R2M35U
US8980829, EMPAGLIFLOZIN
VA10802
X5927
ZINC36520252
Paragraph IV (Patent) Challenges for JARDIANCE
Tradename Dosage Ingredient NDA Submissiondate
JARDIANCE TABLET;ORAL empagliflozin 204629 2018-08-01

US Patents and Regulatory Information for JARDIANCE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 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 JARDIANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/01 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131 C 2014 039 Romania   Start Trial PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
1730131 C01730131/02 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2187879 122017000024 Germany   Start Trial PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879 CA 2017 00019 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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