SYNJARDY XR Drug Patent Profile
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Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?
Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-six patent family members in forty countries.
The generic ingredient in SYNJARDY XR 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 Xr
Synjardy Xr 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 fifteen 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
Summary for SYNJARDY XR
| International Patents: | 166 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Patent Applications: | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SYNJARDY XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY XR |
| DailyMed Link: | SYNJARDY XR at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SYNJARDY XR
Generic Entry Date for SYNJARDY XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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 XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Genuine Research Center, Egypt | Phase 1 |
| Hikma Pharma | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for SYNJARDY XR
Paragraph IV (Patent) Challenges for SYNJARDY XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SYNJARDY XR | Extended-release Tablets | empagliflozin; metformin hydrochloride | 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | 208658 | 3 | 2018-08-01 |
US Patents and Regulatory Information for SYNJARDY XR
SYNJARDY XR is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYNJARDY XR 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 XR
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 compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
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
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
| 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 | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | 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 | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | 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 |
Expired US Patents for SYNJARDY XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SYNJARDY XR
When does loss-of-exclusivity occur for SYNJARDY XR?
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 XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 1294363 | 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 |
| Lithuania | 2981271 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 0197783 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY XR
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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