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Last Updated: May 19, 2022

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-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

See drug prices for APLENZIN

Drug Sales Revenue Trends for APLENZIN

See drug sales revenues for APLENZIN

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
Valeant Pharmaceuticals International, Inc.Phase 4
Bausch Health Americas, Inc.Phase 4
SRI InternationalPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release formulations of a bupropion salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS

Modified release formulations of a bupropion salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release formulations of a bupropion salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Bupropion hydrobromide and therapeutic applications
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release formulations of a bupropion salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release formulations of a bupropion salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Bupropion hydrobromide and therapeutic applications
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Patent: 08285660
Estimated Expiration: See Plans and Pricing

Patent: 08320915
Estimated Expiration: See Plans and Pricing

Canada

Patent: 78626
Estimated Expiration: See Plans and Pricing

Patent: 55596
Estimated Expiration: See Plans and Pricing

Patent: 99588
Estimated Expiration: See Plans and Pricing

Patent: 00733
Estimated Expiration: See Plans and Pricing

China

Patent: 1534808
Estimated Expiration: See Plans and Pricing

Patent: 1784266
Estimated Expiration: See Plans and Pricing

Patent: 1903016
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51360
Estimated Expiration: See Plans and Pricing

Patent: 70385
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 09
Estimated Expiration: See Plans and Pricing

Patent: 259
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 077999
Estimated Expiration: See Plans and Pricing

Patent: 109923
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96002
Estimated Expiration: See Plans and Pricing

Patent: 32124
Estimated Expiration: See Plans and Pricing

Patent: 85139
Estimated Expiration: See Plans and Pricing

Patent: 14650
Estimated Expiration: See Plans and Pricing

Patent: 74308
Estimated Expiration: See Plans and Pricing

Patent: 02621
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 42811
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5760
Estimated Expiration: See Plans and Pricing

Patent: 8989
Estimated Expiration: See Plans and Pricing

Japan

Patent: 95615
Estimated Expiration: See Plans and Pricing

Patent: 08546841
Estimated Expiration: See Plans and Pricing

Patent: 10535740
Estimated Expiration: See Plans and Pricing

Patent: 11500865
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10001449
Estimated Expiration: See Plans and Pricing

Patent: 10003872
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1375
Estimated Expiration: See Plans and Pricing

Patent: 2925
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1000015
Estimated Expiration: See Plans and Pricing

Patent: 1000044
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 08368
Estimated Expiration: See Plans and Pricing

Patent: 85942
Estimated Expiration: See Plans and Pricing

Patent: 85943
Estimated Expiration: See Plans and Pricing

Patent: 07147343
Estimated Expiration: See Plans and Pricing

Patent: 10107843
Estimated Expiration: See Plans and Pricing

Patent: 10116863
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3695
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0711123
Estimated Expiration: See Plans and Pricing

Patent: 1000425
Estimated Expiration: See Plans and Pricing

Patent: 1003036
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1306635
Estimated Expiration: See Plans and Pricing

Patent: 080026098
Estimated Expiration: See Plans and Pricing

Patent: 100055402
Estimated Expiration: See Plans and Pricing

Patent: 100077182
Estimated Expiration: See Plans and Pricing

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
Russian Federation 2485943 БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF) See Plans and Pricing
Colombia 6270385 BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009056550 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APLENZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 349 22-2017 Slovakia See Plans and Pricing PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 2017/059 Ireland See Plans and Pricing 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
0656775 CR 2000 00018 Denmark See Plans and Pricing PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
>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.