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Last Updated: June 16, 2021

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JANUVIA Drug Profile


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Which patents cover Januvia, and what generic alternatives are available?

Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and twenty-seven patent family members in forty-six countries.

The generic ingredient in JANUVIA is sitagliptin phosphate. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Januvia

Januvia was eligible for patent challenges on October 16, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $7.2bn, indicating a strong incentive for generic entry.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are nine tentative approvals for the generic drug (sitagliptin phosphate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JANUVIA
Drug Prices for JANUVIA

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Drug Sales Revenue Trends for JANUVIA

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for JANUVIA
Generic Entry Date for JANUVIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Recent Clinical Trials for JANUVIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rabin Medical CenterPhase 2
University of PennsylvaniaPhase 4
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2

See all JANUVIA clinical trials

Pharmacology for JANUVIA
Paragraph IV (Patent) Challenges for JANUVIA
Tradename Dosage Ingredient NDA Submissiondate
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-11-06
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-25
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2012-06-19
JANUVIA TABLET;ORAL sitagliptin phosphate 021995 2010-10-18

US Patents and Regulatory Information for JANUVIA

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 JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for JANUVIA

Supplementary Protection Certificates for JANUVIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 PA2014045 Lithuania   Get Started Free PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 CA 2014 00062 Denmark   Get Started Free PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1412357 C300357 Netherlands   Get Started Free PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357 C20070004 00113 Estonia   Get Started Free PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007
1084705 CA 2014 00065 Denmark   Get Started Free PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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