LINAGLIPTIN - Generic Drug Details
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What are the generic sources for linagliptin and what is the scope of patent protection?
Linagliptin
is the generic ingredient in five branded drugs marketed by Invagen Pharms, Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in eight NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Linagliptin has four hundred and fifty-nine patent family members in forty-five countries.
There are nineteen drug master file entries for linagliptin. Three suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for LINAGLIPTIN
International Patents: | 459 |
US Patents: | 15 |
Tradenames: | 5 |
Applicants: | 4 |
NDAs: | 8 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 142 |
Patent Applications: | 3,298 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINAGLIPTIN |
What excipients (inactive ingredients) are in LINAGLIPTIN? | LINAGLIPTIN excipients list |
DailyMed Link: | LINAGLIPTIN at DailyMed |
Recent Clinical Trials for LINAGLIPTIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Diabetes & Endocrinology Foundation | N/A |
Medanta, The Medicity, India | N/A |
Generic filers with tentative approvals for LINAGLIPTIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 5MG | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 2.5MG; 1G | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 2.5MG; 850MG | 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
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for LINAGLIPTIN
Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN
Paragraph IV (Patent) Challenges for LINAGLIPTIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRADJENTA | Tablets | linagliptin | 5 mg | 201280 | 11 | 2015-05-04 |
US Patents and Regulatory Information for LINAGLIPTIN
Expired US Patents for LINAGLIPTIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LINAGLIPTIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Trajenta | linagliptin | EMEA/H/C/002110 Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. |
Authorised | no | no | no | 2011-08-23 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LINAGLIPTIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 358618 | USOS DE INHIBIDORES DE DPP IV. (USES OF DPP-IV INHIBITORS.) | ⤷ Subscribe |
Canada | 2651019 | UTILISATIONS D'INHIBITEURS DE L'ENZYME DPP IV (USES OF DPP-IV INHIBITORS) | ⤷ Subscribe |
Japan | 2008519005 | ⤷ Subscribe | |
Poland | 3029040 | ⤷ Subscribe | |
Malaysia | 148496 | DPP IV INHIBITOR FORMULATIONS | ⤷ Subscribe |
South Korea | 20090021152 | USE OF DPP-IV INHIBITORS | ⤷ Subscribe |
Norway | 20140234 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LINAGLIPTIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | C300708 | Netherlands | ⤷ Subscribe | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224 |
1532149 | C01532149/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
1532149 | C20110018 00046 | Estonia | ⤷ Subscribe | PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011 |
1084705 | CR 2014 00065 | Denmark | ⤷ Subscribe | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830 |
1532149 | CA 2013 00001 | Denmark | ⤷ Subscribe | 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 | 621 | Finland | ⤷ Subscribe | |
1532149 | SPC/GB12/006 | United Kingdom | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
LINAGLIPTIN Market Analysis and Financial Projection Experimental
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