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Serving hundreds of leading biopharmaceutical companies globally:

Covington
McKesson
Accenture
Healthtrust
Dow
Argus Health
US Army
Medtronic
Farmers Insurance

Generated: August 20, 2018

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-one patent family members in forty-five countries.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-eight 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
Generic Entry Opportunity 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.

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 202270-002 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for JANUMET XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 100 mg/1000 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for JANUMET XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,168,637 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes ➤ Sign Up
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for JANUMET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00037 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2012022 Lithuania ➤ Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
0287 Netherlands ➤ Sign Up 300287, 20220705, EXPIRES: 20220320
3 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Teva
Medtronic
McKesson
Fish and Richardson
Daiichi Sankyo
Cantor Fitzgerald
Julphar
Cipla

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