DrugPatentWatch Database Preview
GLYXAMBI Drug Patent Profile
Email this page to a colleague
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 thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has five hundred and forty-seven 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 October 14, 2029. This may change due to patent challenges or generic licensing.
There have been ten 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 two 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: | 547 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 12 |
| 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 |
DrugPatentWatch® Estimated 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
Anatomical Therapeutic Chemical (ATC) Classes 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
GLYXAMBI is protected by fourteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GLYXAMBI is ⤷ Sign up for a Free Trial.
This potential generic entry date is based on patent ⤷ Sign up for a Free Trial.
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
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2
DPP IV inhibitor formulations
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
Uses of DPP-IV inhibitors
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Uses of DPP IV inhibitors
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2
FDA Regulatory Exclusivity protecting GLYXAMBI
ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Exclusivity Expiration: ⤷ Sign up for a Free Trial
INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Exclusivity Expiration: ⤷ Sign up for a Free Trial
| 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 | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | RX | Yes | No | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | Y | ⤷ Sign up for a Free Trial | ||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | RX | Yes | No | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free 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 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLYXAMBI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20190015625 | ⤷ Sign up for a Free Trial |
| Spain | 2348576 | ⤷ Sign up for a Free Trial |
| Croatia | P20050157 | ⤷ Sign up for a Free Trial |
| European Patent Office | 1852108 | ⤷ Sign up for a Free Trial |
| Mexico | 358618 | ⤷ Sign up for a Free Trial |
| Poland | 2015754 | ⤷ Sign up for a Free Trial |
| Singapore | 151271 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GLYXAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0896538 | CA 2007 00030 | Denmark | ⤷ Sign up for a Free Trial | |
| 1730131 | CR 2014 00054 | Denmark | ⤷ Sign up for a Free Trial | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527 |
| 1730131 | C01730131/01 | Switzerland | ⤷ Sign up for a Free Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014 |
| 1532149 | 91889 | Luxembourg | ⤷ Sign up for a Free Trial | 91889, EXPIRES: 20260824 |
| 1730131 | 1490061-7 | Sweden | ⤷ Sign up for a Free Trial | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
| 1730131 | 568 | Finland | ⤷ Sign up for a Free Trial | |
| 1532149 | C 2012 003 | Romania | ⤷ Sign up for a Free Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
