Linagliptin; metformin hydrochloride - Generic Drug Details

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What are the generic 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:	61
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
Medanta, The Medicity, India	N/A
Dong Wha Pharmaceutical Co. Ltd.	Phase 1
The First Affiliated Hospital with Nanjing Medical University	N/A

See all linagliptin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG; 1G	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2.5MG; 850MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2.5MG; 500MG	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

Anatomical Therapeutic Chemical (ATC) Classes for linagliptin; metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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 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 XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	201281-003	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	⤷ Sign Up	⤷ Sign Up
>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
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)	⤷ Sign Up
Taiwan	I520738		⤷ Sign Up
Japan	6139004		⤷ Sign Up
Taiwan	200944209	8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions	⤷ Sign Up
Japan	2006503013		⤷ Sign Up
>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	PA2012022	Lithuania	⤷ Sign Up	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	C300569	Netherlands	⤷ Sign Up	PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1532149	CA 2011 00030	Denmark	⤷ Sign Up
1532149	11C0052	France	⤷ Sign Up	PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110830
1532149	1190035-4	Sweden	⤷ Sign Up	PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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