DrugPatentWatch Database Preview
GLYXAMBI Drug Profile
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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.
This drug has four hundred and twenty-three patent family members in forty-six countries.
The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.
Summary for GLYXAMBI
| International Patents: | 423 |
| US Patents: | 13 |
| 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
*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
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | 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 |
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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 | ➤ Sign Up |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for GLYXAMBI
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,321,791 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions | ➤ Sign Up |
| 7,687,469 | Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture | ➤ Sign Up |
| 6,803,357 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 8,513,190 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for GLYXAMBI
Supplementary Protection Certificates for GLYXAMBI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 90035-4 | Sweden | ➤ Sign Up | PRODUCT NAME: LINAGLIPTIN, DESS ENANTIOMERER OCH SALTER DAERAV; REG. NO/DATE: EU/1/11/707/001 20110824 |
| /2014 | Austria | ➤ Sign Up | PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527 |
| 2011 00030 | Denmark | ➤ Sign Up | PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830 |
| 00569 | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
