DrugPatentWatch Database Preview
GLYXAMBI Drug Profile
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.
The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-one 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
| 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 | ||||
| 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 | ➤ 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 |
Paragraph IV (Patent) Challenges for GLYXAMBI
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg/5 mg and 25 mg/5 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for GLYXAMBI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200700974 | ➤ Sign Up |
| Taiwan | 200944209 | ➤ Sign Up |
| Japan | 2005041885 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for GLYXAMBI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 90061-7 | Sweden | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522 |
| 2014000099 | Germany | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 555 | Luxembourg | ➤ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
