Generic Tradjenta Availability

Last updated on Nov 7, 2023.

Tradjenta is a brand name of linagliptin, approved by the FDA in the following formulation(s):

TRADJENTA (linagliptin - tablet;oral)

Manufacturer: BOEHRINGER INGELHEIM
Approval date: May 2, 2011
Strength(s): 5MG ^[RLD] ^[AB]

Has a generic version of Tradjenta been approved?

A generic version of Tradjenta has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Tradjenta and have been approved by the FDA:

linagliptin tablet;oral

Manufacturer: SUNSHINE
Approval date: August 31, 2021
Strength(s): 5MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tradjenta. 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.

Treatment for diabetes in patients inappropriate for metformin therapy
Patent 10,034,877
Issued: July 31, 2018
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- August 5, 2029
  ✓
  Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT
Treatment for diabetes in patients inappropriate for metformin therapy
Patent 10034877*PE
Issued: July 31, 2018
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- February 5, 2030
DPP IV inhibitor formulations
Patent 11,033,552
Issued: June 15, 2021
Inventor(s): Kohlrausch Anja & Romer Patrick & Seiffert Gerd
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation and their use to treat diabetes mellitus.
Patent expiration dates:
- May 4, 2027
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  Drug product
DPP IV inhibitor formulations
Patent 11033552*PE
Issued: June 15, 2021
Inventor(s): Kohlrausch Anja & Romer Patrick & Seiffert Gerd
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation and their use to treat diabetes mellitus.
Patent expiration dates:
- November 4, 2027
Patent 7,407,955
Issued: November 30, -0001
Patent expiration dates:
- May 2, 2025
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  Drug substance
  ✓
  Drug product
Patent 7407955*PED
Issued: November 30, -0001
Patent expiration dates:
- November 2, 2025
  ✓
  Pediatric exclusivity
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent 8,119,648
Issued: February 21, 2012
Inventor(s): Himmelsbach Frank & Langkopf Elke & Eckhardt Matthias & Mark Michael & Maier Roland & Lotz Ralf
Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG
The present invention relates to substituted xanthines of general formula
Patent expiration dates:
- August 12, 2023
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
- August 12, 2023
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  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent 8,178,541
Issued: May 15, 2012
Inventor(s): Himmelsbach Frank & Langkopf Elke & Eckhardt Matthias & Mark Michael & Maier Roland & Lotz Ralf & Tadayyon Mohammad
Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG
The present invention relates to substituted xanthines of general formula
Patent expiration dates:
- August 12, 2023
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONYLUREA
- August 12, 2023
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  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
- August 12, 2023
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  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE
- August 12, 2023
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  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
Uses of DPP-IV inhibitors
Patent 8,673,927
Issued: March 18, 2014
Inventor(s): Dugi Klaus & Himmelsbach Frank & Mark Michael
Assignee(s): Boehringer Ingelheim International GmbH
The specification describes the use of selected DPP IV inhibitors for the treatment of physiological functional disorders and for reducing the risk of the occurrence of such functional disorders in at-risk patient groups. In addition, the use of the above-mentioned DPP IV inhibitors in conjunction with other active substances is described, by means of which improved treatment outcomes can be achieved. These applications may be used to prepare corresponding medicaments.
Patent expiration dates:
- May 4, 2027
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
  ✓
  Sponsor has requested patent be delisted
Uses of DPP-IV inhibitors
Patent 8673927*PED
Issued: March 18, 2014
Inventor(s): Dugi Klaus & Himmelsbach Frank & Mark Michael
Assignee(s): Boehringer Ingelheim International GmbH
The specification describes the use of selected DPP IV inhibitors for the treatment of physiological functional disorders and for reducing the risk of the occurrence of such functional disorders in at-risk patient groups. In addition, the use of the above-mentioned DPP IV inhibitors in conjunction with other active substances is described, by means of which improved treatment outcomes can be achieved. These applications may be used to prepare corresponding medicaments.
Patent expiration dates:
- November 4, 2027
  ✓
  Pediatric exclusivity
Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Patent 8,846,695
Issued: September 30, 2014
Inventor(s): Dugi Klaus
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for improving glycemic control in type 2 diabetes patients with inadequate glycemic control despite metformin therapy.
Patent expiration dates:
- June 4, 2030
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
  ✓
  Sponsor has requested patent be delisted
Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Patent 8846695*PED
Issued: September 30, 2014
Inventor(s): Dugi Klaus
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for improving glycemic control in type 2 diabetes patients with inadequate glycemic control despite metformin therapy.
Patent expiration dates:
- December 4, 2030
  ✓
  Pediatric exclusivity
Treatment for diabetes in patients inappropriate for metformin therapy
Patent 8,853,156
Issued: October 7, 2014
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- March 5, 2031
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN
  ✓
  Drug product
Treatment for diabetes in patients inappropriate for metformin therapy
Patent 8853156*PED
Issued: October 7, 2014
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- September 5, 2031
  ✓
  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
Treatment for diabetes in patients inappropriate for metformin therapy
Patent 9,486,526
Issued: November 8, 2016
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- August 5, 2029
  ✓
  Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND WHO ARE INELIGIBLE FOR METFORMIN THERAPY BY ADMINISTERING LINAGLIPTIN
Treatment for diabetes in patients inappropriate for metformin therapy
Patent 9486526*PED
Issued: November 8, 2016
Inventor(s): Dugi Klaus & Graefe-Mody Eva Ulrike & Harper Ruth & Woerle Hans-Juergen
Assignee(s): Boehringer Ingelheim International GmbH
The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Patent expiration dates:
- February 5, 2030
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- March 30, 2023 - ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
- June 20, 2026 - REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
- December 20, 2026 - PEDIATRIC EXCLUSIVITY

More about Tradjenta (linagliptin)

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.
AB	Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

3.3 / 10

73 Reviews

Images

Tradjenta 5 mg (D5 Logo)