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Last Updated: July 12, 2020

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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 one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in forty-five 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.

US ANDA Litigation and 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 November 24, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $5.2bn, indicating a strong incentive for generic entry (peak sales were $5.6bn in 2016).

There have been eight 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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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
University of PennsylvaniaPhase 4
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2
University of DundeeN/A

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   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006   Start Trial   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JANUVIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 SPC/GB07/046 United Kingdom   Start Trial PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323
1084705 C300706 Netherlands   Start Trial PRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
1084705 C300709 Netherlands   Start Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Johnson and Johnson
Moodys
Merck
AstraZeneca

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