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

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021515

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NDA 021515 describes WELLBUTRIN XL, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from one supplier. Additional details are available on the WELLBUTRIN XL profile page.

The generic ingredient in WELLBUTRIN XL 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 021515
Tradename:WELLBUTRIN XL
Applicant:Valeant Intl
Ingredient:bupropion hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021515
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515 NDA Bausch Health Americas, Inc. 0187-0730 0187-0730-07 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0730-07)
WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515 NDA Bausch Health Americas, Inc. 0187-0730 0187-0730-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0730-30)
Paragraph IV (Patent) Challenges for 021515
Tradename Dosage Ingredient NDA Submissiondate
WELLBUTRIN XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 021515 2004-09-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 28, 2003TE:AB3RLD:Yes

Expired US Patents for NDA 021515

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003   Start Trial   Start Trial
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003   Start Trial   Start Trial
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003   Start Trial   Start Trial
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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