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Linagliptin - Generic Drug Details
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What are the generic drug sources for linagliptin and what is the scope of freedom to operate?
Linagliptin
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and is included in three 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 three hundred and seventeen 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 five tentative approvals for this compound.
Summary for linagliptin
International Patents: | 317 |
US Patents: | 15 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 19 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 78 |
Clinical Trials: | 129 |
Patent Applications: | 1,893 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Oslo | Phase 2 |
Norwegian Diabetes Association | Phase 2 |
University Hospital, Akershus | Phase 2 |
Generic filers with tentative approvals for LINAGLIPTIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5MG | TABLET;ORAL |
Start Trial | Start Trial | 2.5MG;1GM | TABLET;ORAL |
Start Trial | Start Trial | 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
Paragraph IV (Patent) Challenges for LINAGLIPTIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
TRADJENTA | TABLET;ORAL | linagliptin | 201280 | 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 | Start Trial | Start Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for linagliptin
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 1812438 | Start Trial |
European Patent Office | 2308878 | Start Trial |
European Patent Office | 2015754 | Start Trial |
Eurasian Patent Organization | 202091999 | Start Trial |
Mexico | 2011006936 | Start Trial |
Poland | 403104 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for linagliptin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | SPC/GB12/006 | United Kingdom | Start 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 | C01532149/01 | Switzerland | Start Trial | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
1084705 | C01084705/04 | Switzerland | Start Trial | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
1532149 | C300504 | Netherlands | Start Trial | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN ZOUT; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824 |
2187879 | 2017/018 | Ireland | Start Trial | PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111 |
1532149 | C20110018 00046 | Estonia | Start Trial | PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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