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

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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020358

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NDA 020358 describes WELLBUTRIN SR, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two suppliers. Additional details are available on the WELLBUTRIN SR profile page.

The generic ingredient in WELLBUTRIN SR is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 020358
Tradename:WELLBUTRIN SR
Applicant:Glaxosmithkline
Ingredient:bupropion hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020358
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358 NDA GlaxoSmithKline LLC 0173-0135 0173-0135-55 60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55)
WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358 NDA GlaxoSmithKline LLC 0173-0722 0173-0722-00 60 TABLET, FILM COATED in 1 BOTTLE (0173-0722-00)
Paragraph IV (Patent) Challenges for 020358
Tradename Dosage Ingredient NDA Submissiondate
WELLBUTRIN SR TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020358

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Oct 4, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Oct 4, 1996TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Oct 4, 1996TE:AB1RLD:Yes

Expired US Patents for NDA 020358

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
AstraZeneca
McKinsey
Mallinckrodt
Colorcon

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