Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

JANUMET XR Drug Profile

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When do Janumet Xr patents expire, and what generic alternatives are available?

Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-three patent family members in forty-five countries.

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

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

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Drug Sales Revenue Trends for JANUMET XR

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Recent Clinical Trials for JANUMET XR

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SponsorPhase
Population Health Research InstitutePhase 3
University Medical Centre LjubljanaPhase 4
Woman'sPhase 4

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Recent Litigation for JANUMET XR

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District Court Litigation
Case NameDate
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc.2019-02-13
Merck Sharp & Dohme Corp. v. Sandoz Inc.2019-02-13

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PTAB Litigation
PetitionerDate
Endo Pharmaceutical Inc.2014-04-17
Purdue Pharma L.P.2014-01-24

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Pharmacology for JANUMET XR

US Patents and Regulatory Information for JANUMET XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for JANUMET XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 100 mg/1000 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for JANUMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 PA2014026 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1532149 92128 Luxembourg   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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