DrugPatentWatch Database Preview
GLYXAMBI Drug Profile
Which patents cover Glyxambi, and what generic alternatives are available?
Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and eighty-six 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. Two suppliers are listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.
Summary for GLYXAMBI
| International Patents: | 486 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| 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.
Recent Litigation for GLYXAMBI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited | 2019-08-28 |
| Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited | 2019-07-11 |
| Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited | 2018-11-08 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2016-08-10 |
| Mylan Pharmaceuticals Inc. | 2016-08-10 |
Pharmacology for GLYXAMBI
Synonyms for GLYXAMBI
| Empagliflozin / Linagliptin |
| Empagliflozin and Linagliptin |
| Empagliflozin mixture with Linagliptin |
| Linagliptin and Empagliflozin |
| S900006430 |
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
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | 206073-002 | Jan 30, 2015 | Start Trial | Start Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | Start Trial | Start Trial |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLYXAMBI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2606650 | Start Trial |
| Hungary | S1700020 | Start Trial |
| Ecuador | SP109977 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GLYXAMBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | PA2014035,C1730131 | Lithuania | Start Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | 200 5026-2014 | Slovakia | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
| 1532149 | 91889 | Luxembourg | Start Trial | 91889, EXPIRES: 20260824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
