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Last Updated: December 7, 2022

Empagliflozin; linagliptin; metformin hydrochloride - Generic Drug Details


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What are the generic drug sources for empagliflozin; linagliptin; metformin hydrochloride and what is the scope of freedom to operate?

Empagliflozin; linagliptin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin; metformin hydrochloride has four hundred and eighty-five patent family members in forty-eight countries.

One supplier is listed for this compound.

Recent Clinical Trials for empagliflozin; linagliptin; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityN/A
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A
Wuxi People's HospitalN/A

See all empagliflozin; linagliptin; metformin hydrochloride clinical trials

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIJARDY XR Extended-release Tablets empagliflozin; linagliptin; metformin hydrochloride 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g 212614 1 2020-05-26

US Patents and Regulatory Information for empagliflozin; linagliptin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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; metformin hydrochloride

International Patents for empagliflozin; linagliptin; metformin hydrochloride

Country Patent Number Title Estimated Expiration
Brazil 0313648 8-[3-amino-piperidin-1-il]-xantinas, a preparação das mesmas e uso das mesmas como medicamento See Plans and Pricing
New Zealand 555324 Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines See Plans and Pricing
Mexico 2010001696 COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO. (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTE D BENZENE DERIVATIVE.) See Plans and Pricing
Portugal 2287164 See Plans and Pricing
Egypt 25011 Amino-piperidin-1-yl-xanthines, the production thereof and the use of the same as medicaments. See Plans and Pricing
Serbia 58097 TERAPEUTSKE PRIMENE EMPAGLIFLOZINA (THERAPEUTIC USES OF EMPAGLIFLOZIN) See Plans and Pricing
Israel 241102 שימושים רפואיים באמפאגליפלוזין (Therapeutic uses of empagliflozin) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for empagliflozin; linagliptin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/03 Switzerland See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131 SPC/GB14/070 United Kingdom See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 20140527
2187879 132017000050485 Italy See Plans and Pricing PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1532149 621 Finland See Plans and Pricing
2187879 1790019-2 Sweden See Plans and Pricing PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
1730131 C01730131/04 Switzerland See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1532149 8/2012 Austria See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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