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Details for New Drug Application (NDA): 202270

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NDA 202270 describes JANUMET XR, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the JANUMET XR profile page.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-seven drug master file entries for this compound. Three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

Summary for NDA: 202270

Tradename:
JANUMET XR
Applicant:
Merck Sharp Dohme
Ingredient:
metformin hydrochloride; sitagliptin phosphate
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 202270

Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 202270

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL 202270 NDA Merck Sharp & Dohme Corp. 0006-0078 0006-0078-28 2 BOTTLE in 1 CARTON (0006-0078-28) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL 202270 NDA Merck Sharp & Dohme Corp. 0006-0078 0006-0078-61 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 50MG BASE
Approval Date:Feb 2, 2012TE:RLD:No
Patent:6,340,475Patent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,635,280Patent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,699,871Patent Expiration:Jul 26, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE

Expired Orange Book Patents for NDA: 202270

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 20126,635,280► subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 20126,340,475► subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 20126,340,475► subscribe
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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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