DrugPatentWatch Database Preview
APLENZIN Drug Profile
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Which patents cover Aplenzin, and when can generic versions of Aplenzin launch?
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: | 47 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,413 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APLENZIN |
| DailyMed Link: | APLENZIN at DailyMed |
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
| .alpha.-(tert-Butylamino)-m-chloropropiophenone |
| ( -)-2-(tert-Butylamino)-3'-chloropropiophenone |
| ( -)-2-(tert-Butylamino)-3'-chlorpropiophenon |
| (-)-2-(tert-butylamino)-3'-chloropropiophenone |
| (-)-2-(tert-Butylamino)-3'-chlorpropiophenon |
| (.+/-.)-2-(tert-Butylamino)-3'-chloropropiophenone |
| (.+/-.)-Bupropion |
| (+-)-1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone |
| (+-)-2-(tert-Butylamino)-3'-chloropropiophenone |
| (+-)-2-(tert-Butylamino)-3'-chlorpropiophenon |
| (+-)-Bupropion |
| (+/-)-bupropion |
| 1-(3-Chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone |
| 1-(3-CHLOROPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-1-PROPANONE |
| 1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]propan-1-one |
| 1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)- |
| 1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, (.+/-.)- |
| 1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, (+-)- |
| 1-Propanone, 1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl)amino]- |
| 2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone # |
| 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one |
| 2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide |
| 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide |
| 2-(Tert-Butylamino)-3'-chloropropiophenone |
| 2-tert-Butylamino-1-(3-chlorophenyl)propan-1-one |
| 3'-Chloro-alpha-(tert-butylamino)propiophenone |
| 34841-39-9 |
| 34911-55-2 |
| 8068AH |
| 905818-69-1 |
| AB00053756 |
| AB00053756_20 |
| AB00053756_21 |
| AB00053756-16 |
| AB00053756-18 |
| AB00053756-19 |
| AC-197 |
| AC1L198Y |
| ACM34841399 |
| ACM34911552 |
| AK-34646 |
| AK-75761 |
| AKOS015917698 |
| AKOS015961770 |
| alpha-(tert-butylamino)-m-chloropropiophenone |
| AM807634 |
| Amfebutamon |
| Amfebutamona |
| Amfebutamona [INN-Spanish] |
| Amfebutamone |
| AMFEBUTAMONE HCl |
| amfebutamonum |
| Amfebutamonum [INN-Latin] |
| AN-16060 |
| API0008795 |
| Aplenzin ER |
| AX8020179 |
| BBL029065 |
| BC219839 |
| BDBM50048392 |
| BPBio1_000042 |
| BRD-A05186015-003-05-7 |
| BRN 2101062 |
| BSPBio_000038 |
| BSPBio_002247 |
| Budeprion (Salt/Mix) |
| bupropion |
| bupropion (amfebutamone) |
| Bupropion (INN) |
| Bupropion (Old RN) |
| Bupropion (USAN) |
| Bupropion [INN:BAN] |
| bupropion HBr |
| Bupropion hydrobromide |
| Bupropion hydrobromide (USAN) |
| Bupropion hydrobromide [USAN] |
| Bupropion hydrocloride |
| Bupropion SR |
| Bupropion+naltrexone |
| bupropionhydrochloride |
| BW-323 |
| C-6222 |
| C06860 |
| CCG-100858 |
| CCG-204261 |
| CHEBI:3219 |
| CHEMBL1201735 |
| CHEMBL894 |
| Contrave (TN) |
| CPD000472526 |
| D01TMQ |
| D07591 |
| D07938 |
| D0X4ZR |
| DB01156 |
| DivK1c_007050 |
| DR000564 |
| DTXSID7022706 |
| Elont |
| Elontril |
| FT-0630586 |
| GTPL7135 |
| HMS2051G10 |
| HMS2089G14 |
| HMS2232P04 |
| HMS3369P11 |
| HMS3393G10 |
| HSDB 6988 |
| I14-9201 |
| Jsp006301 |
| KB-213778 |
| KBio1_001994 |
| KBio2_002143 |
| KBio2_004711 |
| KBio2_007279 |
| KBio3_001467 |
| KBioGR_001168 |
| KBioSS_002143 |
| L000725 |
| Lopac0_000166 |
| LS-122817 |
| MLS001424015 |
| MRF-0000143 |
| NC00108 |
| NCGC00015122-03 |
| NCGC00015122-04 |
| NCGC00015122-06 |
| NCGC00015122-07 |
| NCGC00015122-09 |
| NCGC00089751-02 |
| NCI60_002714 |
| NSC315851 |
| OR261068 |
| Prestwick0_000249 |
| Prestwick1_000249 |
| Prestwick2_000249 |
| Prestwick3_000249 |
| Propiophenone, 2-(tert-butylamino)-3'-chloro- |
| SAM001246699 |
| SBI-0050154.P003 |
| SCHEMBL38777 |
| SCHEMBL636116 |
| SMR000472526 |
| SNPPWIUOZRMYNY-UHFFFAOYSA-N |
| SPBio_001817 |
| SPBio_002257 |
| SpecPlus_000954 |
| Spectrum_001663 |
| Spectrum2_001659 |
| Spectrum3_000644 |
| Spectrum4_000614 |
| Spectrum5_001406 |
| STL373006 |
| TL8002604 |
| Wellbatrin |
| Wellbutrin (Salt/Mix) |
| Wellbutrin, Zyban |
| WSTCENNATOVXKQ-UHFFFAOYSA-N |
| Zyban |
| Zyban (Salt/Mix) |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | 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 |
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Paragraph IV (Patent) Challenges for APLENZIN
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 522 mg | ➤ Subscribe | 2009-12-24 |
| ➤ Subscribe | Extended-release Tablets | 174 mg | ➤ Subscribe | 2009-09-28 |
| ➤ Subscribe | Extended-release Tablets | 348 mg | ➤ Subscribe | 2009-09-24 |
Non-Orange Book US Patents for APLENZIN
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,354,453 | Bupropion hydrobromide and therapeutic applications | ➤ Sign Up |
| 7,569,611 | Modified release formulations of a bupropion salt | ➤ Sign Up |
| 7,553,992 | Modified release formulations of a bupropion salt | ➤ Sign Up |
| 7,884,136 | Modified-release formulations of a bupropion salt | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for APLENZIN
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2474308 | ➤ Sign Up |
| Costa Rica | 11259 | ➤ Sign Up |
| European Patent Office | 2214650 | ➤ Sign Up |
| Australia | 2008320915 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for APLENZIN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| /2000 | Austria | ➤ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
| 0918 | 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 |
| C/GB00/019 | United Kingdom | ➤ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607 |
| 2017000109 | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
