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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
Queensland Health
Medtronic
UBS
Dow
Accenture
McKesson
Chinese Patent Office

Generated: July 22, 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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 202270-003 Feb 2, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe ➤ Try a Free Trial

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 ➤ Try a Free Trial
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
8,168,637 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes ➤ Try a Free Trial
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
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
0080004 00019 Estonia ➤ Try a Free Trial PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
C0041 France ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
2014026,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
00569 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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