Generic Trijardy XR Availability

Last updated on Oct 9, 2024.

Trijardy XR is a brand name of empagliflozin/linagliptin/metformin, approved by the FDA in the following formulation(s):

TRIJARDY XR (empagliflozin; linagliptin; metformin hydrochloride - tablet, extended release;oral)

Manufacturer: BOEHRINGER INGELHEIM
Approval date: January 27, 2020
Strength(s): 5MG;2.5MG;1GM ^[RLD], 10MG;5MG;1GM ^[RLD], 12.5MG;2.5MG;1GM ^[RLD], 25MG;5MG;1GM ^[RLD]

Has a generic version of Trijardy XR been approved?

No. There is currently no therapeutically equivalent version of Trijardy XR available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trijardy XR. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent 10,022,379
Issued: July 17, 2018
Inventor(s): Friedl Thomas & Braun Michael & Egusa Kenji & Fujita Hikaru & Maruyama Megumi & Nishioka Takaaki
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Patent expiration dates:
- April 2, 2029
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
  ✓
  Drug product
Pharmaceutical composition, methods for treating and uses thereof
Patent 10,258,637
Issued: April 16, 2019
Inventor(s): Broedl Uli Christian & Macha Sreeraj & von Eynatten Maximilian & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Patent expiration dates:
- April 3, 2034
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  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
Pharmaceutical composition, methods for treating and uses thereof
Patent 10258637*PE
Issued: April 16, 2019
Inventor(s): Broedl Uli Christian & Macha Sreeraj & von Eynatten Maximilian & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Patent expiration dates:
- October 3, 2034
Pharmaceutical composition, methods for treating and uses thereof
Patent 10,406,172
Issued: September 10, 2019
Inventor(s): Eickelmann Peter & Mark Michael & Seman Leo John & Thomas Leo & Broedl Uli & Grempler Rolf
Assignee(s): Boehringer Ingelheim International GmbH
The invention relates to a pharmaceutical composition according to the claim comprising an SGLT2 inhibitor, a DPPIV inhibitor and a third antidiabetic agent which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Patent expiration dates:
- June 15, 2030
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  Patent 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
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  Drug product
Pharmaceutical compositions
Patent 10,596,120
Issued: March 24, 2020
Inventor(s): Ito Masanori & Egusa Kenji & Messerschmid Roman & Schneider Peter
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and/or a SGLT-2 inhibitor drug, and metformin XR, processes for the preparation thereof, and their use to treat certain diseases.
Patent expiration dates:
- March 7, 2032
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  Patent 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
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  Drug product
- March 7, 2032
  ✓
  Patent 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
  ✓
  Drug product
Patent 11,090,323
Patent expiration dates:
- April 3, 2034
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
Patent 11090323*PE
Patent expiration dates:
- October 3, 2034
Patent 11,564,886
Patent expiration dates:
- March 7, 2032
  ✓
  Patent 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
  ✓
  Drug product
Patent 11,833,166
Patent expiration dates:
- April 3, 2034
  ✓
  Patent 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 <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
- April 3, 2034
  ✓
  Patent 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 <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
Patent 7,407,955
Patent expiration dates:
- May 2, 2025
  ✓
  Drug substance
  ✓
  Drug product
Patent 7407955*PED
Patent expiration dates:
- November 2, 2025
  ✓
  Pediatric exclusivity
Patent 7,579,449
Patent expiration dates:
- August 1, 2028
  ✓
  Drug substance
Patent 7579449*PED
Patent expiration dates:
- February 1, 2029
  ✓
  Pediatric exclusivity
Patent 7,713,938
Patent expiration dates:
- April 15, 2027
  ✓
  Drug substance
  ✓
  Drug product
Patent 7713938*PED
Patent expiration dates:
- October 15, 2027
  ✓
  Pediatric exclusivity
Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent 8,551,957
Issued: October 8, 2013
Inventor(s): Dugi Klaus & Mark Michael & Thomas Leo & Himmelsbach Frank
Assignee(s): Boehringer Ingelheim International GmbH
The invention relates to a pharmaceutical composition according to the claim comprising a glucopyranosyl-substituted benzene derivative in combination with a DPP IV inhibitor which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Patent expiration dates:
- October 14, 2029
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
  ✓
  Drug product
Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent 8551957*PED
Issued: October 8, 2013
Inventor(s): Dugi Klaus & Mark Michael & Thomas Leo & Himmelsbach Frank
Assignee(s): Boehringer Ingelheim International GmbH
The invention relates to a pharmaceutical composition according to the claim comprising a glucopyranosyl-substituted benzene derivative in combination with a DPP IV inhibitor which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Patent expiration dates:
- April 14, 2030
  ✓
  Pediatric exclusivity
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent 8,883,805
Issued: November 11, 2014
Inventor(s): Pfrengle Waldemar & Pachur Thorsten & Nicola Thomas & Duran Adil
Assignee(s): Boehringer Ingelheim International GmbH
The invention relates to an improved process for preparing enantiomerically pure 8-(3-aminopiperidin-1-yl)-xanthines.
Patent expiration dates:
- November 26, 2025
  ✓
  Drug product
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent 8883805*PED
Issued: November 11, 2014
Inventor(s): Pfrengle Waldemar & Pachur Thorsten & Nicola Thomas & Duran Adil
Assignee(s): Boehringer Ingelheim International GmbH
The invention relates to an improved process for preparing enantiomerically pure 8-(3-aminopiperidin-1-yl)-xanthines.
Patent expiration dates:
- May 26, 2026
  ✓
  Pediatric exclusivity
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent 9,155,705
Issued: October 13, 2015
Inventor(s): Friedl Thomas & Braun Michael & Egusa Kenji & Fujita Hikaru & Maruyama Megumi & Nishioka Takaaki
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Patent expiration dates:
- May 21, 2030
  ✓
  Drug product
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent 9,415,016
Issued: August 16, 2016
Inventor(s): Friedl Thomas & Braun Michael & Egusa Kenji & Fujita Hikaru & Maruyama Megumi & Nishioka Takaaki
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Patent expiration dates:
- April 2, 2029
  ✓
  Drug product
Pharmaceutical composition, methods for treating and uses thereof
Patent 9,949,998
Issued: April 24, 2018
Inventor(s): Broedl Uli Christian & Macha Sreeraj & von Eynatten Maximilian & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Patent expiration dates:
- June 11, 2034
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
Pharmaceutical composition, methods for treating and uses thereof
Patent 9949998*PED
Issued: April 24, 2018
Inventor(s): Broedl Uli Christian & Macha Sreeraj & von Eynatten Maximilian & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Patent expiration dates:
- December 11, 2034
  ✓
  Pediatric exclusivity

More about Trijardy XR (empagliflozin / linagliptin / metformin)

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.