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APLENZIN Drug Profile
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Which patents cover Aplenzin, and when can generic versions of Aplenzin launch?
Aplenzin is a drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-one patent family members in seventeen 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.
US ANDA Litigation and Generic Entry Outlook for Aplenzin
Aplenzin was eligible for patent challenges on December 31, 1968.
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 have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (bupropion hydrobromide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for APLENZIN
| International Patents: | 51 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 10 |
| Clinical Trials: | 1 |
| Patent Applications: | 51 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APLENZIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APLENZIN |
| DailyMed Link: | APLENZIN at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 4 |
| University of Bristol | Phase 4 |
| National Institute on Drug Abuse (NIDA) | Phase 4 |
Recent Litigation for APLENZIN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Valeant International (Barbados) SRL v. Paddock Laboratories, Inc. | 2010-04-15 |
| Valeant International, Bermuda v. Watson Pharmaceuticals Inc. | 2010-02-19 |
| Biovail Laboratories International SRL v. Watson Pharmaceuticals Inc. | 2010-02-18 |
Pharmacology for APLENZIN
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Synonyms for APLENZIN
| 2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide |
| 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide |
| 905818-69-1 |
| AKOS015917698 |
| Aplenzin (TN) |
| Aplenzin ER |
| bupropion HBr |
| Bupropion hydrobromide |
| Bupropion hydrobromide (USAN) |
| Bupropion hydrobromide [USAN] |
| CHEMBL1201735 |
| D07938 |
| I14-9201 |
| SCHEMBL636116 |
| WSTCENNATOVXKQ-UHFFFAOYSA-N |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 561375 | Start Trial |
| South Africa | 201000425 | Start Trial |
| Costa Rica | 11259 | Start Trial |
| Japan | 2010535740 | Start Trial |
| South Korea | 20100055402 | Start Trial |
| Mexico | 2010001449 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APLENZIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 2017C/064 | Belgium | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | CR 2017 00062 | Denmark | Start 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 | LUC00054 | Luxembourg | Start Trial | 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 |
| 0656775 | CR 2000 00018 | Denmark | Start Trial | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| 2316456 | 65/2017 | Austria | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330 |
| 2316456 | C201730057 | Spain | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
