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Generated: December 10, 2018

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APLENZIN Drug Profile

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When do Aplenzin patents expire, and what generic alternatives are available?

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.

Drug patent expirations by year for APLENZIN
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.

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
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
Valeant Pharms North 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

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Paragraph IV (Patent) Challenges for APLENZIN
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 522 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 348 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 174 mg ➤ Subscribe ➤ Sign Up

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
2000 00018 Denmark ➤ Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: 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
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
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
C/GB00/019 United Kingdom ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Dow
Merck
Farmers Insurance
UBS
Harvard Business School
Express Scripts
Chubb

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