Linagliptin; metformin hydrochloride - Generic Drug Details
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What are the generic sources for linagliptin; metformin hydrochloride and what is the scope of freedom to operate?
Linagliptin; metformin hydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Sunshine, and Zydus Pharms, and is included in four NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Linagliptin; metformin hydrochloride has three hundred and forty-seven patent family members in forty-five countries.
One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for linagliptin; metformin hydrochloride
International Patents: | 347 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 59 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for linagliptin; metformin hydrochloride |
DailyMed Link: | linagliptin; metformin hydrochloride at DailyMed |
Recent Clinical Trials for linagliptin; metformin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dong Wha Pharmaceutical Co. Ltd. | Phase 1 |
Wuxi People's Hospital | N/A |
The First Affiliated Hospital with Nanjing Medical University | N/A |
See all linagliptin; metformin hydrochloride clinical trials
Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG; 1G | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG; 850MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG; 500MG | 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 linagliptin; metformin hydrochloride
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JENTADUETO XR | Extended-release Tablets | linagliptin; metformin hydrochloride | 2.5 mg/1000 mg 5 mg/1000 mg | 208026 | 1 | 2018-03-28 |
JENTADUETO | Tablets | linagliptin; metformin hydrochloride | 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg | 201281 | 8 | 2015-05-04 |
US Patents and Regulatory Information for linagliptin; metformin hydrochloride
Expired US Patents for linagliptin; metformin hydrochloride
EU/EMA Drug Approvals for linagliptin; metformin hydrochloride
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Jentadueto | linagliptin, metformin hydrochloride | EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. |
Authorised | no | no | no | 2012-07-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for linagliptin; metformin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 606538 | Treatment of diabetes in patients with inadequate glycemic control despite metformin therapy comprising a dpp-iv inhibitor | ⤷ Try a Trial |
Serbia | 52142 | 8-[3-AMINO-PIPERIDIN-1-IL]-KSANTINI, NJIHOVO DOBIJANJE I NJIHOVA PRIMENA KAO FARMACEUTSKIH KOMPOZICIJA (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS) | ⤷ Try a Trial |
European Patent Office | 3029040 | PROCEDE DE FABRICATION DE CHIRALE 8-(3-AMINO-PIPERIDINE-1-YL)-XANTHINE (METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL) -XANTHINES) | ⤷ Try a Trial |
Japan | 2011516456 | ⤷ Try a Trial | |
Luxembourg | 91889 | ⤷ Try a Trial | |
European Patent Office | 2287164 | Procédé pour la préparation des 8-(3-aminopiperidin-1-yl)-xanthines chirales (Process for the manufacture of chiral 8-(3-aminopiperidin-1-yl)-xanthines) | ⤷ Try a Trial |
Portugal | 1532149 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for linagliptin; metformin hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | C 2012 003 | Romania | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824 |
1730131 | C01730131/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017 |
1084705 | CR 2014 00065 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830 |
1532149 | SPC/GB12/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830 |
1532149 | CA 2011 00030 | Denmark | ⤷ Try a Trial | |
1532149 | CR 2011 00030 | Denmark | ⤷ Try a Trial | 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 |
1532149 | PA2011013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011 08 24 EU/1/11/707/002, 2011 08 24 EU/1/11/707/003, 2011 08 24 EU/1/11/707/004, 2011 08 24 EU/1/11/707/005, 2011 08 24 EU/1/11/707/006, 2011 08 24 EU/1/11/707/007, 2011 08 24 EU/1/11/707/008, 2011 08 24 EU/1/11/707/00 2011082 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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