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Colorcon
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Healthtrust
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Generated: July 17, 2018

DrugPatentWatch Database Preview

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 thirteen 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 eighteen drug master file entries for this compound. Three suppliers are 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:13
Formulation / Manufacturing:see details
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
Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
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 N 0597-0270-12
JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0270 N 0597-0270-73

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM
Approval Date:May 27, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
Patent:➤ Sign UpPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN

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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Teva
Julphar
Farmers Insurance
Accenture
McKesson
Covington
Fish and Richardson

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