Pharmaceutical Business Intelligence

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Wellbutrin Xl is a drug marketed by Valeant Intl and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in WELLBUTRIN XL is bupropion hydrochloride. There are thirty-six drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for Tradename: WELLBUTRIN XL

Suppliers / Packagers: see list7
Bulk Api Vendors: see list79
Clinical Trials: see list20
Patent Applications: see list728
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:WELLBUTRIN XL at DailyMed

Pharmacology for Tradename: WELLBUTRIN XL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Intl
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL021515-001Aug 28, 2003RXYesNo6,096,341► subscribe ► subscribe
Valeant Intl
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL021515-002Aug 28, 2003RXYesYes6,096,341► subscribe ► subscribe
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Paragraph IV activity for: WELLBUTRIN XL

Drugname Dosage Strength RLD Submissiondate
bupropion hydrochlorideExtended-release Tablets150 mg and 300 mgWellbutrin XL9/21/2004

Non-Orange Book Patents for Tradename: WELLBUTRIN XL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,143,327 Delayed release coated tablet of bupropion hydrochloride► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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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.