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Generated: April 27, 2017

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Repaglinide - Generic Drug Details

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What are the generic drug sources for repaglinide and what is the scope of freedom to operate?

Repaglinide
is the generic ingredient in two branded drugs marketed by Actavis Totowa, Standard Chem Pharm, Aurobindo Pharma Ltd, Gemini Labs Llc, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, and Paddock Llc, and is included in eight NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for repaglinide. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: repaglinide

Tradenames:2
Patents:1
Applicants:8
NDAs:8
Drug Master File Entries: see list16
Suppliers / Packagers: see list18
Bulk Api Vendors: see list66
Clinical Trials: see list12
Patent Applications: see list5,754
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:repaglinide at DailyMed

Pharmacology for Ingredient: repaglinide

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Tentative approvals for REPAGLINIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL0.5MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Totowa
REPAGLINIDE
repaglinide
TABLET;ORAL090008-001Jan 22, 2014ABRXNoNo► Subscribe► Subscribe
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-003Dec 22, 1997ABRXYesYes► Subscribe► Subscribe
Sun Pharm Inds Inc
REPAGLINIDE
repaglinide
TABLET;ORAL077571-003Jul 11, 2013ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
REPAGLINIDE
repaglinide
TABLET;ORAL090252-002Jan 22, 2014ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
REPAGLINIDE
repaglinide
TABLET;ORAL090252-003Jan 22, 2014ABRXNoNo► Subscribe► 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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