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Last Updated: October 27, 2020

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Details for New Drug Application (NDA): 208026

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NDA 208026 describes JENTADUETO XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JENTADUETO XR profile page.

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.
Summary for 208026
Tradename:JENTADUETO XR
Applicant:Boehringer Ingelheim
Ingredient:linagliptin; metformin hydrochloride
Patents:11
Generic Entry Opportunity Date for 208026
Generic Entry Date for 208026*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 208026
Suppliers and Packaging for NDA: 208026
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0270 0597-0270-12 1 BOTTLE in 1 CARTON (0597-0270-12) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0270 0597-0270-73 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73)
Paragraph IV (Patent) Challenges for 208026
Tradename Dosage Ingredient NDA Submissiondate
JENTADUETO XR TABLET, EXTENDED RELEASE;ORAL linagliptin; metformin hydrochloride 208026 2018-03-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM
Approval Date:May 27, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Regulatory Exclusivity Expiration:Jul 3, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Patent:  Start TrialPatent Expiration:Apr 2, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 208026

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.