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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Harvard Business School
McKesson
Medtronic
Dow
Deloitte
Colorcon
Fuji
Farmers Insurance

Generated: December 16, 2017

DrugPatentWatch Database Preview

APLENZIN Drug Profile

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Which patents cover Aplenzin, and when can generic versions of Aplenzin launch?

Aplenzin is a drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.

This drug has forty-nine patent family members in seventeen countries and three supplementary protection certificates in three countries.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupropion hydrobromide profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for APLENZIN

Drugname Dosage Strength RLD Submissiondate
bupropion hydrobromideExtended-release Tablets522 mgAplenzin12/24/2009
bupropion hydrobromideExtended-release Tablets174 mgAplenzin9/28/2009
bupropion hydrobromideExtended-release Tablets348 mgAplenzin9/24/2009

Non-Orange Book Patents for Tradename: APLENZIN

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
8,354,453Bupropion hydrobromide and therapeutic applications► Subscribe
7,553,992Modified release formulations of a bupropion salt► Subscribe
8,932,628Modified release formulations of a bupropion salt► Subscribe
9,504,640Modified release formulations of a bupropion salt► Subscribe
7,884,136Modified-release formulations of a bupropion salt► Subscribe
7,579,380Modified release formulations of a bupropion salt► Subscribe
7,645,901Modified release formulations of a bupropion salt► Subscribe
7,569,611Modified release formulations of a bupropion salt► Subscribe
7,563,823Modified release formulations of a bupropion salt► 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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International Patent Family for Tradename: APLENZIN

Country Document Number Estimated Expiration
Canada2655596► Subscribe
Canada2578626► Subscribe
South Korea20080026098► Subscribe
Canada2699588► Subscribe
European Patent Office2474308► Subscribe
World Intellectual Property Organization (WIPO)2009056550► Subscribe
Israel228989► Subscribe
Japan2010535740► Subscribe
Canada2700733► Subscribe
Russian Federation2010116863► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: APLENZIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Daiichi Sankyo
Farmers Insurance
Queensland Health
Citi
Harvard Business School
McKinsey
Julphar
Moodys

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.

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