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 |
⤷ Sign Up | ⤷ Sign Up | 5MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG; 1G | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Norway | 20130968 | ⤷ Sign Up | |
European Patent Office | 2283819 | Compositions d'inhibiteurs de la DPP IV (DPP IV inhibitor formulations) | ⤷ Sign Up |
Poland | 216134 | ⤷ Sign Up | |
Eurasian Patent Organization | 201001167 | 8-[-3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Sign Up |
Hong Kong | 1134077 | -氨基-哌啶- -基 -黃嘌呤,其製備方法及作為藥物製劑的用途 (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS 8-[3---1-]-) | ⤷ Sign Up |
South Korea | 20140068267 | METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LINAGLIPTIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | 118 5013-2011 | Slovakia | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824 |
1532149 | C 2012 003 | Romania | ⤷ Sign Up | 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 |
2187879 | 20/2017 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115 |
2187879 | 122017000024 | Germany | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111 |
2187879 | CA 2017 00019 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115 |
1084705 | PA2014044 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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