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Last Updated: December 6, 2023

JANUMET XR Drug Patent Profile


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Which patents cover Janumet Xr, and when can generic versions of Janumet Xr launch?

Janumet Xr is a drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and twenty-seven patent family members in forty-six countries.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Janumet Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $548mm indicating the motivation for generic entry (peak sales were $1.1bn in 2018).

There have been twenty-eight 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 (metformin hydrochloride; sitagliptin phosphate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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

See drug prices for JANUMET XR

Drug Sales Revenue Trends for JANUMET XR

See drug sales revenues for JANUMET XR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JANUMET XR
Generic Entry Date for JANUMET 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 JANUMET XR

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

SponsorPhase
Eva PharmaPhase 1
Genuine Research Center, EgyptPhase 1
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2

See all JANUMET XR clinical trials

Pharmacology for JANUMET XR
Paragraph IV (Patent) Challenges for JANUMET XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 100 mg/1000 mg 202270 1 2012-10-22
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 202270 1 2012-03-16

US Patents and Regulatory Information for JANUMET XR

JANUMET XR is protected by three US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUMET XR is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  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.

Patents protecting JANUMET XR

Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting JANUMET XR

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
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
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes 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

Expired US Patents for JANUMET XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for JANUMET XR

See the table below for patents covering JANUMET XR around the world.

Country Patent Number Title Estimated Expiration
Germany 59703959 ⤷  Try a Trial
Australia 2004253889 Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor ⤷  Try a Trial
Japan 2010248253 METHOD FOR REGULATING GLUCOSE METABOLISM AND REAGENT RELATED THERETO ⤷  Try a Trial
European Patent Office 1520582 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JANUMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 106 4-2007 Slovakia ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321
1412357 342 Finland ⤷  Try a Trial
1084705 C01084705/03 Switzerland ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
1506211 42/2014 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Medtronic
Moodys
Johnson and Johnson
Harvard Business School

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.