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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Deloitte
Healthtrust
UBS
Johnson and Johnson
Boehringer Ingelheim
Fuji
Express Scripts
Cantor Fitzgerald

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077537

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NDA 077537 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Pharmadax Inc, Teva, Zydus Pharms Usa Inc, Dava Pharms Inc, Hikma, Mylan, Sandoz, and Sanofi Aventis Us, and is included in twenty-one NDAs. It is available from thirty-six suppliers. Additional details are available on the GLYBURIDE profile page.

The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for 077537

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 077537

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 077537

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE glyburide TABLET;ORAL 077537 ANDA Citron Pharma LLC 57237-020 57237-020-01 100 TABLET in 1 BOTTLE (57237-020-01)
GLYBURIDE glyburide TABLET;ORAL 077537 ANDA Citron Pharma LLC 57237-020 57237-020-50 50 TABLET in 1 BOTTLE (57237-020-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Oct 18, 2007TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 18, 2007TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 18, 2007TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Medtronic
UBS
Daiichi Sankyo
Cipla
Cantor Fitzgerald
Farmers Insurance
Novartis
AstraZeneca

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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