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 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 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 six tentative approvals for this compound.
Summary for LINAGLIPTIN
International Patents: | 417 |
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 | 201281-003 | Jan 30, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | 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 | |||
>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 |
---|---|---|---|
Japan | 2013199505 | USE OF DPP-IV INHIBITOR | ⤷ Try a Trial |
China | 102846619 | Uses of DPP-IV inhibitors | ⤷ Try a Trial |
Argentina | 077875 | 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS | ⤷ Try a Trial |
Germany | 50312295 | ⤷ 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 |
---|---|---|---|---|
2187879 | 276 10-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
1532149 | PA2012022 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
1532149 | PA2011013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011 08 24 EU/1/11/707/002, 2011 08 24 EU/1/11/707/003, 2011 08 24 EU/1/11/707/004, 2011 08 24 EU/1/11/707/005, 2011 08 24 EU/1/11/707/006, 2011 08 24 EU/1/11/707/007, 2011 08 24 EU/1/11/707/008, 2011 08 24 EU/1/11/707/00 2011082 |
2187879 | PA2017014 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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