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Last Updated: June 16, 2021

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JENTADUETO XR Drug 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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-two 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. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Jentadueto Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 6, 2033. This may change due to patent challenges or generic licensing.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (linagliptin; metformin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JENTADUETO XR
Drug Prices for JENTADUETO XR

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for JENTADUETO XR
Generic Entry Date for JENTADUETO XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JENTADUETO XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boehringer IngelheimPhase 1

See all JENTADUETO XR clinical trials

Pharmacology for JENTADUETO XR
Paragraph IV (Patent) Challenges for JENTADUETO XR
Tradename Dosage Ingredient NDA Submissiondate
JENTADUETO XR TABLET, EXTENDED RELEASE;ORAL linagliptin; metformin hydrochloride 208026 2018-03-28

US Patents and Regulatory Information for JENTADUETO XR

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   Get Started Free   Get Started Free Y   Get Started Free
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 208026-002 May 27, 2016   Get Started Free   Get Started Free
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016   Get Started Free   Get Started Free
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JENTADUETO XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 SPC/GB14/086 United Kingdom   Get Started Free PRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
1084705 C01084705/01 Switzerland   Get Started Free PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
0896538 07C0035 France   Get Started Free PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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