TRIJARDY XR Drug Patent Profile
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Which patents cover Trijardy Xr, and when can generic versions of Trijardy Xr launch?
Trijardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and eighty-four patent family members in forty-eight countries.
The generic ingredient in TRIJARDY XR is empagliflozin; linagliptin; 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; linagliptin; metformin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Trijardy Xr
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 21, 2030. This may change due to patent challenges or generic licensing.
There have been twenty-one 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 TRIJARDY XR
| International Patents: | 484 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRIJARDY XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRIJARDY XR |
| What excipients (inactive ingredients) are in TRIJARDY XR? | TRIJARDY XR excipients list |
| DailyMed Link: | TRIJARDY XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRIJARDY XR
Generic Entry Date for TRIJARDY 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.
Pharmacology for TRIJARDY XR
Anatomical Therapeutic Chemical (ATC) Classes for TRIJARDY XR
Paragraph IV (Patent) Challenges for TRIJARDY XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TRIJARDY XR | Extended-release Tablets | empagliflozin; linagliptin; metformin hydrochloride | 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g | 212614 | 1 | 2020-05-26 |
US Patents and Regulatory Information for TRIJARDY XR
TRIJARDY XR is protected by seventeen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIJARDY XR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 TRIJARDY XR
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
Pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
Pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 AND LINAGLIPTIN
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-002 | Jan 27, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-004 | Jan 27, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 TRIJARDY XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-002 | Jan 27, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-001 | Jan 27, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-002 | Jan 27, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-001 | Jan 27, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRIJARDY XR
When does loss-of-exclusivity occur for TRIJARDY XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1175
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09232043
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0911273
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 20450
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 09000809
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1983073
Estimated Expiration: ⤷ Try a Trial
Patent: 3083672
Estimated Expiration: ⤷ Try a Trial
Patent: 6215190
Estimated Expiration: ⤷ Try a Trial
Patent: 3648422
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 51277
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 85410
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010489
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 9395
Estimated Expiration: ⤷ Try a Trial
Patent: 8435
Estimated Expiration: ⤷ Try a Trial
Patent: 1001577
Estimated Expiration: ⤷ Try a Trial
Patent: 1300121
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 85410
Estimated Expiration: ⤷ Try a Trial
Patent: 53403
Estimated Expiration: ⤷ Try a Trial
Patent: 44374
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 49485
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 41649
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 88428
Estimated Expiration: ⤷ Try a Trial
Patent: 22068
Estimated Expiration: ⤷ Try a Trial
Patent: 11516456
Estimated Expiration: ⤷ Try a Trial
Patent: 13237707
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 1232
Estimated Expiration: ⤷ Try a Trial
Patent: 10010819
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 200
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7747
Estimated Expiration: ⤷ Try a Trial
Patent: 9580
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 091730
Estimated Expiration: ⤷ Try a Trial
Patent: 140960
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 85410
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1005664
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1611314
Estimated Expiration: ⤷ Try a Trial
Patent: 1775942
Estimated Expiration: ⤷ Try a Trial
Patent: 110005690
Estimated Expiration: ⤷ Try a Trial
Patent: 160042174
Estimated Expiration: ⤷ Try a Trial
Patent: 170056021
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 96124
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 27816
Estimated Expiration: ⤷ Try a Trial
Patent: 0946534
Estimated Expiration: ⤷ Try a Trial
Patent: 1509941
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000431
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1818886
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 4136
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 747
Estimated Expiration: ⤷ Try a Trial
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 TRIJARDY XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2683366 | COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE LA METFORMINE ET UN INHIBITEUR DE DPP-4 OU UN INHIBITEUR DE SGLT-2 (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR) | ⤷ Try a Trial |
| Eurasian Patent Organization | 036618 | СПОСОБ ТЕРАПЕВТИЧЕСКОГО ЛЕЧЕНИЯ ВЫРАЖЕННОГО ДИАБЕТА 2 ТИПА С ПОМОЩЬЮ ИНГИБИТОРА DPP IV (METHOD OF THERAPEUTIC TREATMENT OF MANIFEST TYPE 2 DIABETES USING DPP IV INHIBITOR) | ⤷ Try a Trial |
| European Patent Office | 1294363 | COMPRIMES DESTINES A ACCROITRE LA RETENTION GASTRIQUE DE FORMES POSOLOGIQUES ORALES GONFLANTES A LIBERATION CONTROLEE (TABLET SHAPES TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORMS) | ⤷ Try a Trial |
| Canada | 2908635 | USAGES THERAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) | ⤷ Try a Trial |
| Chile | 2015002940 | Usos terapéuticos de empaglifozina. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRIJARDY XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2187879 | 2017020 | Norway | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209 |
| 1730131 | CA 2014 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522 |
| 1532149 | CA 2013 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
| 1532149 | CR 2011 00030 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830 |
| 1532149 | 621 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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