Patent Information                                 CONFIDENTIAL                                           1

 

Patent Information

 

Pursuant to 21.C.F.R. §§314.53

 

for

 

Wellbutrin XL^TM (bupropion hydrochloride) Extended-Release Tablets

 

NDA 21-515

 

 

The following is provided in accord with the Drug Price Competition and Patent Term Restoration Act of 1984:

 

Trade Name:                 Wellbutrin XL^TM

 

Active Ingredient:          bupropion hydrochloride

 

Strength:                       150mg, 300mg

 

Dosage Form:               tablet, oral

 

 

Applicable Patent Numbers and Expiration Dates:

 

Patent No:                    US 6,096,341

 

Expires:                        30 October 2018

 

Owner:                         Pharma Pass LLC

                                    Licensed to Biovail Corporation

                                    Sublicensed to GlaxoSmithKline

 

Type of Patent:             Drug product

 

 

 

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