DrugPatentWatch Database Preview
GLYXAMBI Drug Profile
» See Plans and Pricing
When do Glyxambi patents expire, and what generic alternatives are available?
Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and fifty-three 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.
US ANDA Litigation and 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 October 14, 2029. This may change due to patent challenges or generic licensing.
There have been eight 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 is one tentative approval for the generic drug (empagliflozin; linagliptin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for GLYXAMBI
International Patents: | 453 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for GLYXAMBI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLYXAMBI |
DailyMed Link: | GLYXAMBI at DailyMed |


Generic Entry Opportunity Date for GLYXAMBI
Generic Entry Date for GLYXAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
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
Paragraph IV (Patent) Challenges for GLYXAMBI
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
GLYXAMBI | TABLET;ORAL | empagliflozin; linagliptin | 206073 | 2018-08-01 |
US Patents and Regulatory Information for GLYXAMBI
Expired US Patents for GLYXAMBI
International Patents for GLYXAMBI
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | E044308 | Start Trial |
Hong Kong | 1081552 | Start Trial |
Austria | 407938 | Start Trial |
Brazil | PI0508830 | Start Trial |
Japan | 2006503013 | Start Trial |
Brazil | 122012026540 | Start Trial |
Germany | 122010000020 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GLYXAMBI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | CA 2014 00065 | Denmark | Start Trial | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824 |
2187879 | LUC00017 | Luxembourg | Start Trial | PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115 |
1084705 | C01084705/04 | Switzerland | Start Trial | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
1730131 | 14C0074 | France | Start Trial | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
1532149 | PA2012022 | Lithuania | Start Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
2187879 | 122017000024 | Germany | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111 |
1084705 | C300707 | Netherlands | Start Trial | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |