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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-002 | Jan 30, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-003 | Jan 30, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
---|---|---|---|
Chile | 2011001635 | Uso de un inhibidor de dpp-4 oral, el cual es 1-[(4-metilquinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(r)-amino-piperidin-1-il)xantina, en una cantidad de 1-10 mg, y metformina para preparar una composicion farmaceutica util para mejorar el control glicemico en pacientes con diabetes tipo 2. | ⤷ Try a Trial |
Brazil | PI0711308 | aplicações de inibidores de dpp iv | ⤷ Try a Trial |
Peru | 20140960 | FORMULACIONES QUE COMPRENDEN UN INHIBIDOR DE DPP4 | ⤷ Try a Trial |
South Korea | 20110107810 | TREATMENT FOR DIABETES IN PATIENTS WITH INADEQUATE GLYCEMIC CONTROL DESPITE METFORMIN THERAPY COMPRISING A DPP-IV INHIBITOR | ⤷ 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 | 8/2012 | Austria | ⤷ Try a Trial | 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 |
1532149 | 2011/039 | Ireland | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824 |
1532149 | CA 2013 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
1532149 | 91889 | Luxembourg | ⤷ Try a Trial | 91889, EXPIRES: 20260824 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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