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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
McKesson
Harvard Business School
Mallinckrodt
Johnson and Johnson

Last Updated: November 17, 2019

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 fifty-one patent family members in seventeen countries.

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

Drug patent expirations by year for APLENZIN
Drug Prices for APLENZIN

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Drug Sales Revenue Trends for APLENZIN

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Generic Entry Opportunity Date for APLENZIN
Generic Entry Date for APLENZIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for APLENZIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SRI InternationalPhase 4
Johns Hopkins UniversityPhase 4
University of BristolPhase 4

See all APLENZIN clinical trials

Recent Litigation for APLENZIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International (Barbados) SRL v. Paddock Laboratories, Inc.2010-04-15
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19
Biovail Laboratories International SRL v. Watson Pharmaceuticals Inc.2010-02-18

See all APLENZIN litigation

Synonyms for APLENZIN
2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide
905818-69-1
AKOS015917698
Aplenzin (TN)
Aplenzin ER
bupropion HBr
Bupropion hydrobromide
Bupropion hydrobromide (USAN)
Bupropion hydrobromide [USAN]
CHEMBL1201735
D07938
I14-9201
SCHEMBL636116
WSTCENNATOVXKQ-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for APLENZIN
Tradename Dosage Ingredient NDA Submissiondate
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-12-24
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-28
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-24

US Patents and Regulatory Information for APLENZIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for APLENZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 CR 2017 00062 Denmark   Start Trial PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2316456 300918 Netherlands   Start Trial PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
0467488 SPC/GB00/019 United Kingdom   Start Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 1790064-8 Sweden   Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Colorcon
Moodys
Dow
Boehringer Ingelheim

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