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Last Updated: April 17, 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

See drug prices for APLENZIN

Drug Sales Revenue Trends for APLENZIN

See drug sales revenues for APLENZIN

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

Anatomical Therapeutic Chemical (ATC) Classes for APLENZIN
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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Modified release formulations of a bupropion salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release formulations of a bupropion salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release formulations of a bupropion salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modified release formulations of a bupropion salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 08285660
Estimated Expiration: ⤷  Try a Trial

Patent: 08320915
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 78626
Estimated Expiration: ⤷  Try a Trial

Patent: 55596
Estimated Expiration: ⤷  Try a Trial

Patent: 99588
Estimated Expiration: ⤷  Try a Trial

Patent: 00733
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1534808
Estimated Expiration: ⤷  Try a Trial

Patent: 1784266
Estimated Expiration: ⤷  Try a Trial

Patent: 1903016
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51360
Estimated Expiration: ⤷  Try a Trial

Patent: 70385
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 09
Estimated Expiration: ⤷  Try a Trial

Patent: 259
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 077999
Estimated Expiration: ⤷  Try a Trial

Patent: 109923
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 96002
Estimated Expiration: ⤷  Try a Trial

Patent: 32124
Estimated Expiration: ⤷  Try a Trial

Patent: 85139
Estimated Expiration: ⤷  Try a Trial

Patent: 14650
Estimated Expiration: ⤷  Try a Trial

Patent: 74308
Estimated Expiration: ⤷  Try a Trial

Patent: 02621
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 42811
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5760
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 95615
Estimated Expiration: ⤷  Try a Trial

Patent: 08546841
Estimated Expiration: ⤷  Try a Trial

Patent: 10535740
Estimated Expiration: ⤷  Try a Trial

Patent: 11500865
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10001449
Estimated Expiration: ⤷  Try a Trial

Patent: 10003872
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1375
Estimated Expiration: ⤷  Try a Trial

Patent: 2925
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1000015
Estimated Expiration: ⤷  Try a Trial

Patent: 1000044
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 08368
Estimated Expiration: ⤷  Try a Trial

Patent: 85942
Estimated Expiration: ⤷  Try a Trial

Patent: 85943
Estimated Expiration: ⤷  Try a Trial

Patent: 07147343
Estimated Expiration: ⤷  Try a Trial

Patent: 10107843
Estimated Expiration: ⤷  Try a Trial

Patent: 10116863
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3695
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0711123
Estimated Expiration: ⤷  Try a Trial

Patent: 1000425
Estimated Expiration: ⤷  Try a Trial

Patent: 1003036
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1306635
Estimated Expiration: ⤷  Try a Trial

Patent: 080026098
Estimated Expiration: ⤷  Try a Trial

Patent: 100055402
Estimated Expiration: ⤷  Try a Trial

Patent: 100077182
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 2502621 Formes cristallines de bupropine HBr (Crystalline forms of bupropion HBr) ⤷  Try a Trial
Israel 185760 הרכבים של מלח בופרופיון בעלי שחרור מותאמים (Modified-release formulations of a bupropion salt) ⤷  Try a Trial
Australia 2008320915 Bupropion hydrobromide and therapeutic applications ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APLENZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0656775 28/2000 Austria ⤷  Try a Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456 CR 2017 00062 Denmark ⤷  Try a 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 122017000109 Germany ⤷  Try a Trial 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
>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.