DrugPatentWatch Database Preview
APLENZIN Drug Profile
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.
Summary for APLENZIN
| International Patents: | 51 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| Clinical Trials: | 1 |
| Patent Applications: | 50 |
| 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 |
|---|---|
| SRI International | Phase 4 |
| Johns Hopkins University | Phase 4 |
| University of Bristol | 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 | 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 | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | Start Trial | Start Trial | 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 | |||
| >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 |
|---|---|---|
| Russian Federation | 2010107843 | Start Trial |
| Russian Federation | 2485943 | Start Trial |
| New Zealand | 582925 | Start Trial |
| Israel | 228989 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APLENZIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 300918 | Netherlands | Start Trial | 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 |
| 0467488 | SPC/GB00/019 | United Kingdom | Start Trial | PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607 |
| 2316456 | 1790064-8 | Sweden | 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; REG. NO/DATE: EU/1/14/988 20150330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
