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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Summary for APLENZIN
| International Patents: | 52 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 2 |
| Patent Applications: | 99 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APLENZIN |
| Drug Sales Revenues: | Drug sales revenues for APLENZIN |
| What excipients (inactive ingredients) are in APLENZIN? | APLENZIN excipients list |
| DailyMed Link: | APLENZIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for APLENZIN
*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
| Sponsor | Phase |
|---|---|
| Bausch Health Americas, Inc. | Phase 4 |
| Valeant Pharmaceuticals International, Inc. | Phase 4 |
| University of Bristol | Phase 4 |
Pharmacology for APLENZIN
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007002597 | ⤷ Sign Up | |
| Japan | 2011500865 | ⤷ Sign Up | |
| Japan | 2010535740 | ⤷ Sign Up | |
| South Africa | 200711123 | Modified-release formulations of a bupropion salt | ⤷ Sign Up |
| Russian Federation | 2485942 | БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF) | ⤷ Sign Up |
| Canada | 2700733 | BROMHYDRATE DE BUPROPION ET APPLICATIONS THERAPEUTIQUES (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 | CA 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 | SPC/GB17/078 | United Kingdom | ⤷ 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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | LUC00054 | Luxembourg | ⤷ 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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | 300918 | Netherlands | ⤷ Sign Up | 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 |
| 2316456 | 122017000109 | Germany | ⤷ Sign Up | 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.
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