JENTADUETO XR Drug Patent Profile
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Which patents cover Jentadueto Xr, and what generic alternatives are available?
Jentadueto Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and thirty-one patent family members in forty-five countries.
The generic ingredient in JENTADUETO XR 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 Jentadueto Xr
A generic version of JENTADUETO XR was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.
Summary for JENTADUETO XR
International Patents: | 331 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 1 |
Patent Applications: | 34 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JENTADUETO XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JENTADUETO XR |
What excipients (inactive ingredients) are in JENTADUETO XR? | JENTADUETO XR excipients list |
DailyMed Link: | JENTADUETO XR at DailyMed |
Recent Clinical Trials for JENTADUETO XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boehringer Ingelheim | Phase 1 |
Pharmacology for JENTADUETO XR
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for JENTADUETO XR
Paragraph IV (Patent) Challenges for JENTADUETO XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JENTADUETO XR | Extended-release Tablets | linagliptin; metformin hydrochloride | 2.5 mg/1000 mg 5 mg/1000 mg | 208026 | 1 | 2018-03-28 |
US Patents and Regulatory Information for JENTADUETO XR
JENTADUETO XR is protected by eight US patents and two FDA Regulatory Exclusivities.
Patents protecting JENTADUETO XR
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Uses of DPP-IV inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Uses of DPP IV inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting JENTADUETO XR
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | 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 JENTADUETO XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for JENTADUETO XR
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 |
International Patents for JENTADUETO XR
When does loss-of-exclusivity occur for JENTADUETO XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0269
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 13229538
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 66421
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14002325
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4220049
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1400986
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 22544
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 04953
Estimated Expiration: ⤷ Try a Trial
India
Patent: 01DEN2014
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 15509519
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 14010560
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014501984
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201405509U
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 140131950
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1400144
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering JENTADUETO XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 200802204 | ПРИМЕНЕНИЕ ИНГИБИТОРОВ DPP IV | ⤷ Try a Trial |
Spain | 2213108 | ⤷ Try a Trial | |
Japan | 2010248252 | METHOD FOR REGULATING GLUCOSE METABOLISM AND REAGENT RELATED THERETO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JENTADUETO XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | SPC/GB12/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830 |
0896538 | CA 2007 00030 | Denmark | ⤷ Try a Trial | |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |