LINAGLIPTIN Drug Patent Profile
✉ Email this page to a colleague
When do Linagliptin patents expire, and when can generic versions of Linagliptin launch?
Linagliptin is a drug marketed by Invagen Pharms, Sunshine, and Zydus Pharms. and is included in five NDAs.
The generic ingredient in LINAGLIPTIN is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Linagliptin
A generic version of LINAGLIPTIN was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LINAGLIPTIN?
- What are the global sales for LINAGLIPTIN?
- What is Average Wholesale Price for LINAGLIPTIN?
Summary for LINAGLIPTIN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 142 |
| Patent Applications: | 1,600 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINAGLIPTIN |
| 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 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Invagen Pharms | LINAGLIPTIN | linagliptin | TABLET;ORAL | 208423-001 | Sep 3, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | linagliptin; metformin hydrochloride | TABLET;ORAL | 208449-003 | Mar 30, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sunshine | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | linagliptin; metformin hydrochloride | TABLET;ORAL | 208336-003 | Aug 30, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
