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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
US Army
Farmers Insurance
Harvard Business School
Express Scripts
McKesson
Boehringer Ingelheim
Cerilliant

Generated: October 22, 2018

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JANUMET XR Drug 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 Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

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.

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
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 202270-002 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
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

Supplementary Protection Certificates for JANUMET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014026 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
128 Luxembourg ➤ Try a Free 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
2008013,C1412357 Lithuania ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
US Army
Farmers Insurance
Harvard Business School
Express Scripts
McKesson
Boehringer Ingelheim
Cerilliant

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