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Last Updated: May 8, 2021

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APLENZIN Drug Profile

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When do Aplenzin patents expire, and what generic alternatives are available?

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

This drug has fifty-three patent family members in eighteen 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.

DrugPatentWatch® Generic Entry Outlook for Aplenzin

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2026. This may change due to patent challenges or generic licensing.

There are three Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

There is one tentative approval for the generic drug (bupropion hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for APLENZIN
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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DrugPatentWatch® Estimated 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

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
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 122017000109 Germany   Get Started for $10 PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 132017000142109 Italy   Get Started for $10 PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 CR 2017 00062 Denmark   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Dow
Moodys
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Merck

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