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JANUVIA Drug Profile

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Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from six suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in JANUVIA is sitagliptin phosphate. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the sitagliptin phosphate profile page.

Summary for Tradename: JANUVIA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Drug Prices: :see details

Pharmacology for Tradename: JANUVIA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXNo6,699,871► subscribeYY ► subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYes7,326,708► subscribeYY ► subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXNo6,699,871► subscribeYY ► subscribe
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Paragraph IV activity for: JANUVIA

Drugname Dosage Strength RLD Submissiondate
sitagliptin phosphateTablets25 mg, 50 mg and 100 mgJanuvia10/18/2010

Non-Orange Book Patents for Tradename: JANUVIA

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
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: JANUVIA

Country Document Number Estimated Expiration
Georgia, Republic ofP20084489► subscribe
Norway335371► subscribe
Netherlands300287► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: JANUVIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008Austria► subscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
C/GB14/082United Kingdom► subscribePRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
0287Netherlands► subscribe300287, 20220705, EXPIRES: 20220320
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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