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Last Updated: November 2, 2024

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APLENZIN Drug Patent 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-two 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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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 Loss of Exclusivity (LOE) 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
Bausch Health Americas, Inc.Phase 4
Valeant Pharmaceuticals International, Inc.Phase 4
University of BristolPhase 4

See all APLENZIN clinical trials

Paragraph IV (Patent) Challenges for APLENZIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
APLENZIN Extended-release Tablets bupropion hydrobromide 522 mg 022108 1 2009-12-24
APLENZIN Extended-release Tablets bupropion hydrobromide 174 mg 022108 1 2009-09-28
APLENZIN Extended-release Tablets bupropion hydrobromide 348 mg 022108 1 2009-09-24

US Patents and Regulatory Information for APLENZIN

APLENZIN is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of APLENZIN is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting APLENZIN

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modified release formulations of a bupropion salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for APLENZIN

When does loss-of-exclusivity occur for APLENZIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06261788
Patent: Modified-release formulations of a bupropion salt
Estimated Expiration: ⤷  Sign Up

Patent: 08285660
Patent: Bupropion hydrobromide and therapeutic applications
Estimated Expiration: ⤷  Sign Up

Patent: 08320915
Patent: Bupropion hydrobromide and therapeutic applications
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 78626
Patent: FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT)
Estimated Expiration: ⤷  Sign Up

Patent: 55596
Patent: SYSTEME DE DELIVRANCE OSMOTIQUE MULTIPARTICULAIRE (MULTIPARTICULATE OSMOTIC DELIVERY SYSTEM)
Estimated Expiration: ⤷  Sign Up

Patent: 99588
Patent: BROMHYDRATE DE BUPROPIONE ET SES APPLICATIONS THERAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 00733
Patent: BROMHYDRATE DE BUPROPION ET APPLICATIONS THERAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1534808
Patent: Modified-release formulations of a bupropion salt
Estimated Expiration: ⤷  Sign Up

Patent: 1784266
Patent: Bupropion hydrobromide and therapeutic applications
Estimated Expiration: ⤷  Sign Up

Patent: 1903016
Patent: Bupropion hydrobromide and therapeutic applications
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51360
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS
Estimated Expiration: ⤷  Sign Up

Patent: 70385
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 09
Patent: FORMULACIONES DE UNA SAL DE BUPROPION DE LIBERACION MODIFICADA
Estimated Expiration: ⤷  Sign Up

Patent: 259
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPUETICAS
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 077999
Patent: FORMULACIONES DE UNA SAL DE BUPROPION DE LIBERACIÓN MODIFICADA
Estimated Expiration: ⤷  Sign Up

Patent: 109923
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPÉUTICAS
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 96002
Patent: FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT)
Estimated Expiration: ⤷  Sign Up

Patent: 32124
Patent: SYSTÈME DE DÉLIVRANCE OSMOTIQUE MULTIPARTICULAIRE (MULTIPARTICULATE OSMOTIC DELIVERY SYSTEM)
Estimated Expiration: ⤷  Sign Up

Patent: 85139
Patent: BROMHYDRATE DE BUPROPION ET APPLICATIONS THÉRAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 14650
Patent: BROMHYDRATE DE BUPROPIONE ET SES APPLICATIONS THÉRAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 74308
Patent: Formulations pharmaceutiques contenant l'hydrobromure de bupropion (Pharmaceutical formulations containing bupropion hydrobromide)
Estimated Expiration: ⤷  Sign Up

Patent: 02621
Patent: Formes cristallines de bupropine HBr (Crystalline forms of bupropion HBr)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 42811
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5760
Patent: הרכבים של מלח בופרופיון בעלי שחרור מותאמים (Modified-release formulations of a bupropion salt)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 95615
Estimated Expiration: ⤷  Sign Up

Patent: 08546841
Estimated Expiration: ⤷  Sign Up

Patent: 10535740
Estimated Expiration: ⤷  Sign Up

Patent: 11500865
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10001449
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS. (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 10003872
Patent: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS. (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 1375
Patent: Bupropion hydrobromide, and crystalline forms, compositions, and uses of this compound
Estimated Expiration: ⤷  Sign Up

Patent: 2925
Patent: Use of bubropion hydrobromide for the prevention of seizures associated with bupropion administration
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1000015
Patent: BROMHIDRATO DE BUPROPIÓN Y APLICACIONES TERAPÉUTICAS
Estimated Expiration: ⤷  Sign Up

Patent: 1000044
Patent: BROMHIDRATO DE BUPROPIÓN Y APLICACIONES TERAPÉUTICAS
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 08368
Patent: ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (MODIFIED RELEASE BUPROPION SALT PREPARATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 85942
Patent: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 85943
Patent: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 07147343
Patent: ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ
Estimated Expiration: ⤷  Sign Up

Patent: 10107843
Patent: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 10116863
Patent: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3695
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0711123
Patent: Modified-release formulations of a bupropion salt
Estimated Expiration: ⤷  Sign Up

Patent: 1000425
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

Patent: 1003036
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1306635
Estimated Expiration: ⤷  Sign Up

Patent: 080026098
Patent: MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT
Estimated Expiration: ⤷  Sign Up

Patent: 100055402
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

Patent: 100077182
Patent: BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APLENZIN around the world.

Country Patent Number Title Estimated Expiration
Colombia 6251360 BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS ⤷  Sign Up
Japan 2011500865 ⤷  Sign Up
South Korea 20100055402 BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS ⤷  Sign Up
Mexico 2010003872 BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS. (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS.) ⤷  Sign Up
Russian Federation 2485942 БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF) ⤷  Sign Up
European Patent Office 2214650 BROMHYDRATE DE BUPROPIONE ET SES APPLICATIONS THÉRAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APLENZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017/059 Ireland ⤷  Sign Up 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; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 132017000142109 Italy ⤷  Sign Up PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 CR 2017 00062 Denmark ⤷  Sign Up 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 C201730057 Spain ⤷  Sign Up PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456 17C1058 France ⤷  Sign Up PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 2017C/064 Belgium ⤷  Sign Up PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.