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Details for New Drug Application (NDA): 201281

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NDA 201281 describes JENTADUETO, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JENTADUETO profile page.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Summary for NDA: 201281

Boehringer Ingelheim
linagliptin; metformin hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 201281

Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 201281

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
linagliptin; metformin hydrochloride
TABLET;ORAL 201281 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0146 0597-0146-18 180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18)
linagliptin; metformin hydrochloride
TABLET;ORAL 201281 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0146 0597-0146-60 60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jan 30, 2012TE:RLD:No
Patent:7,407,955Patent Expiration:May 2, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:8,883,805Patent Expiration:Nov 26, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:9,155,705Patent Expiration:May 21, 2030Product Flag?YSubstance Flag?Delist Request?

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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.