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GLYXAMBI Drug Patent Profile

Which patents cover Glyxambi, and when can generic versions of Glyxambi launch?

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

This drug has five hundred and sixty-two patent family members in forty-seven countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

DrugPatentWatch^® Generic Entry Outlook for Glyxambi

Glyxambi was eligible for patent challenges on May 2, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2030. This may change due to patent challenges or generic licensing.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (empagliflozin; linagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for GLYXAMBI

International Patents:	562
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLYXAMBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYXAMBI
What excipients (inactive ingredients) are in GLYXAMBI?	GLYXAMBI excipients list
DailyMed Link:	GLYXAMBI at DailyMed

See drug prices for GLYXAMBI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLYXAMBI

NDA:

206073

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for GLYXAMBI

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GLYXAMBI

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

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GLYXAMBI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLYXAMBI	Tablets	empagliflozin; linagliptin	10 mg/5 mg and 25 mg/5 mg	206073	9	2018-08-01

US Patents and Regulatory Information for GLYXAMBI

GLYXAMBI is protected by thirteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No			Y		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No					Y

Expired US Patents for GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015

EU/EMA Drug Approvals for GLYXAMBI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Glyxambi	empagliflozin, linagliptin	EMEA/H/C/003833 Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.	Authorised	no	no	no	2016-11-11

International Patents for GLYXAMBI

When does loss-of-exclusivity occur for GLYXAMBI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 GLYXAMBI around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	151271	GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF
Mexico	2020009911	USOS DE INHIBIORES DE DPP IV. (USES OF DPP-IV INHIBITORS.)
World Intellectual Property Organization (WIPO)	9740832
Japan	6564720
Eurasian Patent Organization	010303	8-[3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS)
World Intellectual Property Organization (WIPO)	2006117359
Hong Kong	1188775	吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)

Supplementary Protection Certificates for GLYXAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	PA2014042	Lithuania		PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
1532149	2011/039	Ireland		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
2187879	276 10-2017	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2187879	2017/018	Ireland		PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323