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Generated: October 15, 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 ➤ 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
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 ➤ 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 ➤ 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 202270-003 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
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 202270-001 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 202270-002 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

Supplementary Protection Certificates for JANUMET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00569 Netherlands ➤ Sign Up PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
C/GB07/046 United Kingdom ➤ Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/046 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT SITAGLIPTIN PHOSPHATE MONOHYDRATE, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6212 DATED 11/06/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/03/2022.
/2012 Austria ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
9 5017-2014 Slovakia ➤ Sign Up PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
90041-8 Sweden ➤ Sign Up PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Accenture
Express Scripts
Argus Health
Chinese Patent Office
McKinsey
Daiichi Sankyo
Deloitte
Federal Trade Commission

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