Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050785

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NDA 050785 describes AUGMENTIN XR, which is a drug marketed by Neopharma and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AUGMENTIN XR profile page.

The generic ingredient in AUGMENTIN XR is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 050785
Tradename:AUGMENTIN XR
Applicant:Neopharma
Ingredient:amoxicillin; clavulanate potassium
Patents:5
Paragraph IV (Patent) Challenges for 050785
Tradename Dosage Ingredient NDA Submissiondate
AUGMENTIN XR TABLET, EXTENDED RELEASE;ORAL amoxicillin; clavulanate potassium 050785 2009-01-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 62.5MG BASE
Approval Date:Sep 25, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 4, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)

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