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Last Updated: May 21, 2022

SYNJARDY Drug Patent Profile


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

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

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

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Synjardy

Synjardy 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 August 1, 2028. This may change due to patent challenges or generic licensing.

There have been five 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 SYNJARDY
Drug Prices for SYNJARDY

See drug prices for SYNJARDY

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SYNJARDY
Generic Entry Date for SYNJARDY*:
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 SYNJARDY

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

SponsorPhase
Hikma PharmaPhase 1
Genuine Research Center, EgyptPhase 1

See all SYNJARDY clinical trials

Paragraph IV (Patent) Challenges for SYNJARDY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY Tablets empagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg 206111 4 2018-08-01

US Patents and Regulatory Information for SYNJARDY

SYNJARDY is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYNJARDY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SYNJARDY

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SYNJARDY

When does loss-of-exclusivity occur for SYNJARDY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8041
Estimated Expiration: See Plans and Pricing

Patent: 1845
Estimated Expiration: See Plans and Pricing

Patent: 7512
Estimated Expiration: See Plans and Pricing

Patent: 7513
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05225511
Estimated Expiration: See Plans and Pricing

Austria

Patent: 7938
Estimated Expiration: See Plans and Pricing

Patent: 7013
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0508830
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57801
Estimated Expiration: See Plans and Pricing

Patent: 87639
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10000775
Estimated Expiration: See Plans and Pricing

China

Patent: 30141
Estimated Expiration: See Plans and Pricing

Patent: 3030617
Estimated Expiration: See Plans and Pricing

Patent: 3435581
Estimated Expiration: See Plans and Pricing

Patent: 3450129
Estimated Expiration: See Plans and Pricing

Patent: 3467423
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120627
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12948
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 30131
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066855
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1158
Estimated Expiration: See Plans and Pricing

Patent: 0601584
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 30131
Estimated Expiration: See Plans and Pricing

Patent: 28216
Estimated Expiration: See Plans and Pricing

Patent: 95422
Estimated Expiration: See Plans and Pricing

Patent: 60164
Estimated Expiration: See Plans and Pricing

Patent: 60165
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004012676
Estimated Expiration: See Plans and Pricing

Patent: 2004040168
Estimated Expiration: See Plans and Pricing

Patent: 2004061145
Estimated Expiration: See Plans and Pricing

Patent: 2005009745
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 88775
Estimated Expiration: See Plans and Pricing

Patent: 88776
Estimated Expiration: See Plans and Pricing

Patent: 88777
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 400056
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7043
Estimated Expiration: See Plans and Pricing

Patent: 8714
Estimated Expiration: See Plans and Pricing

Japan

Patent: 81605
Estimated Expiration: See Plans and Pricing

Patent: 47314
Estimated Expiration: See Plans and Pricing

Patent: 47469
Estimated Expiration: See Plans and Pricing

Patent: 07246544
Estimated Expiration: See Plans and Pricing

Patent: 07522143
Estimated Expiration: See Plans and Pricing

Patent: 08208127
Estimated Expiration: See Plans and Pricing

Patent: 08524162
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 555
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1336
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 422
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0464
Estimated Expiration: See Plans and Pricing

Norway

Patent: 5264
Estimated Expiration: See Plans and Pricing

Patent: 14028
Estimated Expiration: See Plans and Pricing

Patent: 064201
Estimated Expiration: See Plans and Pricing

Patent: 140127
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060120
Estimated Expiration: See Plans and Pricing

Patent: 091588
Estimated Expiration: See Plans and Pricing

Patent: 091589
Estimated Expiration: See Plans and Pricing

Poland

Patent: 30131
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 30131
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 365
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 1271
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 30131
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0605511
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1174726
Estimated Expiration: See Plans and Pricing

Patent: 060133021
Estimated Expiration: See Plans and Pricing

Patent: 120007088
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14743
Estimated Expiration: See Plans and Pricing

Patent: 87881
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 23264
Estimated Expiration: See Plans and Pricing

Patent: 0538463
Estimated Expiration: See Plans and Pricing

Patent: 0635599
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 040
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 807
Estimated Expiration: See Plans and Pricing

Patent: 817
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SYNJARDY around the world.

Country Patent Number Title Estimated Expiration
Serbia 55588 FARMACEUTSKA KOMPOZICIJA, FARMACEUTSKI DOZNI OBLIK, POSTUPAK ZA NJIHOVO DOBIJANJE, POSTUPCI LEČENJA I NJIHOVA PRIMENA (PHARMACEUTICAL COMPOSITION, PHARMACEUTICAL DOSAGE FORM, PROCESS FOR THEIR PREPARATION, METHODS FOR TREATING AND USES THEREOF) See Plans and Pricing
Lithuania 2981271 See Plans and Pricing
Malaysia 142108 CRYSTALLINE FORM OF 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS See Plans and Pricing
South Korea 102318213 See Plans and Pricing
Spain 2314743 See Plans and Pricing
Cyprus 1118661 See Plans and Pricing
South Korea 101747152 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYNJARDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 PA2014035 Lithuania See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 C01730131/01 Switzerland See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131 SPC/GB14/070 United Kingdom See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 20140527
1730131 62/2014 Austria See Plans and Pricing PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527
1730131 92555 Luxembourg See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
1730131 122014000099 Germany See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 C 2014 039 Romania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
McKinsey
Dow
McKesson
Johnson and Johnson

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.