TRADJENTA Drug Patent Profile

When do Tradjenta patents expire, and what generic alternatives are available?

Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and fifteen patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tradjenta

A generic version of TRADJENTA was approved as linagliptin by SUNSHINE on August 31^st, 2021.

Summary for TRADJENTA

International Patents:	415
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	10
Patent Applications:	1,898
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRADJENTA
Drug Sales Revenues:	Drug sales revenues for TRADJENTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRADJENTA
What excipients (inactive ingredients) are in TRADJENTA?	TRADJENTA excipients list
DailyMed Link:	TRADJENTA at DailyMed

See drug prices for TRADJENTA

See drug sales revenues for TRADJENTA

Recent Clinical Trials for TRADJENTA

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

Sponsor	Phase
EMS	Phase 3
University of Miami	Phase 4
Northwell Health	Phase 4

See all TRADJENTA clinical trials

Pharmacology for TRADJENTA

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRADJENTA

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for TRADJENTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRADJENTA	Tablets	linagliptin	5 mg	201280	11	2015-05-04

US Patents and Regulatory Information for TRADJENTA

TRADJENTA is protected by fourteen US patents and three FDA Regulatory Exclusivities.

Patents protecting TRADJENTA

FDA Regulatory Exclusivity protecting TRADJENTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes

Expired US Patents for TRADJENTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011

EU/EMA Drug Approvals for TRADJENTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Trajenta	linagliptin	EMEA/H/C/002110 Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.	Authorised	no	no	no	2011-08-23

International Patents for TRADJENTA

When does loss-of-exclusivity occur for TRADJENTA?

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

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 TRADJENTA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1216468
Spain	2158562
Eurasian Patent Organization	201101037	ЛЕЧЕНИЕ ДИАБЕТА У ПАЦИЕНТОВ С НЕАДЕКВАТНЫМ ГЛИКЕМИЧЕСКИМ КОНТРОЛЕМ, НЕСМОТРЯ НА ЛЕЧЕНИЕ МЕТФОРМИНОМ
China	102526737	DPP IV inhibitor formulations
European Patent Office	3539956	PROCEDE DE FABRICATION DE CHIRALE 8-(3-AMINO-PIPERIDINE-1-YL)-XANTHINE (METHOD FOR PRODUCING CHIRAL 8- (3-AMINO-PIPERIDIN-1-YL) -XANTHINES)
Germany	50312295
Japan	2017105849	ＤＰＰ ＩＶインヒビターの使用 (USES OF DPP IV INHIBITORS)

Supplementary Protection Certificates for TRADJENTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	1790019-2	Sweden		PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
0896538	08C0008	France		PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
1084705	C300706	Netherlands		PRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
2187879	132017000050485	Italy		PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1532149	1190035-4	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
2187879	276 10-2017	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1084705	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323