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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Citi
Federal Trade Commission
Baxter
Daiichi Sankyo
Cerilliant
Express Scripts
McKinsey
QuintilesIMS

Generated: January 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 nine patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and nine patent family members in forty-seven 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.
Summary for JANUMET XR
International Patents:209
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 12
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:JANUMET XR at DailyMed
Drug patent expirations by year for JANUMET XR
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Subscribe ➤ Subscribe
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 Submissiondate
➤ Subscribe Extended-release Tablets 100 mg/1000 mg ➤ Subscribe 10/22/2012
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe 3/16/2012

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
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
8,168,637 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes ➤ Subscribe
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
8,440,668 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes ➤ Subscribe
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
7,157,429 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for JANUMET XR

Supplementary Protection Certificates for JANUMET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00037 Denmark ➤ Subscribe 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
C/GB14/084 United Kingdom ➤ Subscribe PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
2007 00061 Denmark ➤ Subscribe
00709 Netherlands ➤ Subscribe PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
0287 Netherlands ➤ Subscribe 300287, 20220705, EXPIRES: 20220320
/2007 Austria ➤ Subscribe PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
2007 00040 Denmark ➤ Subscribe
1084705/04 Switzerland ➤ Subscribe PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
00287 Netherlands ➤ Subscribe PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
00706 Netherlands ➤ Subscribe PRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Merck
Citi
Colorcon
Baxter
Medtronic
McKinsey
Johnson and Johnson

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