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Last Updated: May 10, 2024

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for linagliptin; metformin hydrochloride and what is the scope of patent protection?

Linagliptin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Sunshine, and Zydus Pharms, and is included in four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Linagliptin; metformin hydrochloride has three hundred and eighty-nine patent family members in forty-five countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

International Patents:	389
US Patents:	11
Tradenames:	3
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	59
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	LINAGLIPTIN; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Dong Wha Pharmaceutical Co. Ltd.	Phase 1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	N/A
Wuxi People's Hospital	N/A

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	2.5MG; 850MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	2.5MG; 500MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	2.5MG; 1G	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO XR	Extended-release Tablets	linagliptin; metformin hydrochloride	2.5 mg/1000 mg 5 mg/1000 mg	208026	1	2018-03-28
JENTADUETO	Tablets	linagliptin; metformin hydrochloride	2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg	201281	8	2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sunshine	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208336-003	Aug 30, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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 LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jentadueto	linagliptin, metformin hydrochloride	EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.	Authorised	no	no	no	2012-07-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Australia	2013202252	8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments	⤷ Try a Trial
South Korea	20090021152	USE OF DPP-IV INHIBITORS	⤷ Try a Trial
Poland	2285410		⤷ Try a Trial
New Zealand	606538	Treatment of diabetes in patients with inadequate glycemic control despite metformin therapy comprising a dpp-iv inhibitor	⤷ Try a Trial
Japan	2013237707	NEW FORMULATION, TABLET COMPRISING THE FORMULATION, THE USE AND PROCESS FOR THE PREPARATION	⤷ Try a Trial
Portugal	2287164		⤷ Try a Trial
Taiwan	I469783		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2011013	Lithuania	⤷ Try a Trial	PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011 08 24 EU/1/11/707/002, 2011 08 24 EU/1/11/707/003, 2011 08 24 EU/1/11/707/004, 2011 08 24 EU/1/11/707/005, 2011 08 24 EU/1/11/707/006, 2011 08 24 EU/1/11/707/007, 2011 08 24 EU/1/11/707/008, 2011 08 24 EU/1/11/707/00 2011082
1532149	PA2011013,C1532149	Lithuania	⤷ Try a Trial	PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
1532149	621	Finland	⤷ Try a Trial
1532149	1190035-4	Sweden	⤷ Try a Trial	PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
2187879	2017020	Norway	⤷ Try a Trial	PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209
1532149	11C0052	France	⤷ Try a Trial	PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110830
1532149	PA2012022	Lithuania	⤷ Try a Trial	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
>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.