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Serving leading biopharmaceutical companies globally:

Baxter
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Dow
Covington
Fuji
Healthtrust
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Cerilliant
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021995

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NDA 021995 describes JANUVIA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from four suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JANUVIA profile page.

The generic ingredient in JANUVIA is sitagliptin phosphate. There are twenty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
Summary for 021995
Tradename:JANUVIA
Applicant:Merck Sharp Dohme
Ingredient:sitagliptin phosphate
Patents:7
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 021995
Medical Subject Heading (MeSH) Categories for 021995
Suppliers and Packaging for NDA: 021995
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUVIA sitagliptin phosphate TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)
JANUVIA sitagliptin phosphate TABLET;ORAL 021995 NDA Merck Sharp & Dohme Corp. 0006-0112 0006-0112-28 100 BLISTER PACK in 1 CARTON (0006-0112-28) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Oct 16, 2006TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Apr 24, 2017Product Flag?Substance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Jul 26, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV INHIBITOR
Patent:➤ SubscribePatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021995

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Harvard Business School
Queensland Health
Fuji
Boehringer Ingelheim
AstraZeneca
Cipla
Farmers Insurance

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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