EMPAGLIFLOZIN; LINAGLIPTIN - Generic Drug Details
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What are the generic sources for empagliflozin; linagliptin and what is the scope of freedom to operate?
Empagliflozin; linagliptin
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Empagliflozin; linagliptin has five hundred and sixty-two patent family members in forty-seven countries.
One supplier is listed for this compound. There are three tentative approvals for this compound.
Summary for EMPAGLIFLOZIN; LINAGLIPTIN
International Patents: | 562 |
US Patents: | 19 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 23 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; LINAGLIPTIN |
DailyMed Link: | EMPAGLIFLOZIN; LINAGLIPTIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN
Generic Entry Date for EMPAGLIFLOZIN; LINAGLIPTIN*:
Constraining patent/regulatory exclusivity:
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 Clinical Trials for EMPAGLIFLOZIN; LINAGLIPTIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Diabetes & Endocrinology Foundation | N/A |
Medanta, The Medicity, India | N/A |
Wuxi People's Hospital | N/A |
Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 25MG;5MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG/5MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG/5MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for EMPAGLIFLOZIN; LINAGLIPTIN
Drug Class | Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN; LINAGLIPTIN
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GLYXAMBI | Tablets | empagliflozin; linagliptin | 10 mg/5 mg and 25 mg/5 mg | 206073 | 9 | 2018-08-01 |
US Patents and Regulatory Information for EMPAGLIFLOZIN; LINAGLIPTIN
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 | 206073-001 | Jan 30, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-001 | Jan 27, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-004 | Jan 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-001 | Jan 27, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 |
Expired US Patents for EMPAGLIFLOZIN; LINAGLIPTIN
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 |
Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Glyxambi | empagliflozin, linagliptin | EMEA/H/C/003833 Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin. |
Authorised | no | no | no | 2016-11-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for EMPAGLIFLOZIN; LINAGLIPTIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20050058375 | 8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS | ⤷ Sign Up |
Poland | 2277509 | ⤷ Sign Up | |
Mexico | 2020009911 | USOS DE INHIBIORES DE DPP IV. (USES OF DPP-IV INHIBITORS.) | ⤷ Sign Up |
Brazil | 0313648 | 8-[3-amino-piperidin-1-il]-xantinas, a preparação das mesmas e uso das mesmas como medicamento | ⤷ Sign Up |
Argentina | 087287 | 8-[3-AMINO-PIPERIDIN-1-IL]-XANTINAS, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | PA2012022 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
2187879 | 276 10-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
2187879 | 17C1016 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
1532149 | 621 | Finland | ⤷ Sign Up | |
1532149 | C300569 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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