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 five branded drugs marketed by Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in seven NDAs. There are fourteen 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 sixteen 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: | 416 |
US Patents: | 14 |
Tradenames: | 5 |
Applicants: | 3 |
NDAs: | 7 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 139 |
Patent Applications: | 3,853 |
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 |
---|---|
EMS | Phase 3 |
Huashan Hospital | Phase 3 |
The First Affiliated Hospital with Nanjing Medical University | N/A |
Generic filers with tentative approvals for LINAGLIPTIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 5MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG; 1G | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRADJENTA | Tablets | linagliptin | 5 mg | 201280 | 11 | 2015-05-04 |
US Patents and Regulatory Information for linagliptin
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 | 201281-001 | Jan 30, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
South Korea | 20190015625 | DPP-IV 억제제의 용도 (- Use of DPP-IV inhibitors) | ⤷ Try a Trial |
Mexico | PA05001684 | 8-[3-AMINO-PIPERIDIN-1-IL]-XANTINAS, LA PREPARACION DEL MISMO Y SU USO COMO COMPOSICIONES FARMACEUTICAS. (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS.) | ⤷ Try a Trial |
Ukraine | 84275 | 8-[3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ КАК ЛЕКАРСТВЕННЫХ СРЕДСТВ;8-[3-АМІНОПІПЕРИДИН-1-ІЛ]КСАНТИНИ, СПОСІБ ЇХ ОДЕРЖАННЯ ТА ЇХ ЗАСТОСУВАННЯ ЯК ЛІКАРСЬКИХ ЗАСОБІВ (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PREPARATION THEREOF AND THEIR USE AS PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
Ukraine | 107182 | ЛІКУВАННЯ ДІАБЕТУ У ПАЦІЄНТІВ, ДЛЯ ЯКИХ ЛІКУВАННЯ МЕТФОРМІНОМ Є НЕПРИЙНЯТНИМ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for linagliptin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
1084705 | C01084705/04 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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