LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Drug Patent Profile
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When do Linagliptin And Metformin Hydrochloride patents expire, and when can generic versions of Linagliptin And Metformin Hydrochloride launch?
Linagliptin And Metformin Hydrochloride is a drug marketed by Sunshine and Zydus Pharms and is included in two NDAs.
The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 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 And Metformin Hydrochloride
A generic version of LINAGLIPTIN AND METFORMIN HYDROCHLORIDE was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.
Summary for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Clinical Trials: | 59 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dong Wha Pharmaceutical Co. Ltd. | Phase 1 |
| Wuxi People's Hospital | N/A |
| The First Affiliated Hospital with Nanjing Medical University | N/A |
See all LINAGLIPTIN AND METFORMIN HYDROCHLORIDE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
US Patents and Regulatory Information for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sunshine | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | linagliptin; metformin hydrochloride | TABLET;ORAL | 208336-003 | Aug 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | linagliptin; metformin hydrochloride | TABLET;ORAL | 208449-003 | Mar 30, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sunshine | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE | linagliptin; metformin hydrochloride | TABLET;ORAL | 208336-001 | Aug 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim International GmbH | Jentadueto | linagliptin, metformin hydrochloride | EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. |
Authorised | no | no | no | 2012-07-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
