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Generated: October 15, 2018

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Paroxetine hydrochloride - Generic Drug Details

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What are the generic drug sources for paroxetine hydrochloride and what is the scope of paroxetine hydrochloride patent protection?

Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex Technologies, Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Prinston Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher-smith Labs, and Zydus Pharms Usa, and is included in twenty-three NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for paroxetine hydrochloride. Fifty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for paroxetine hydrochloride
Synonyms for paroxetine hydrochloride
(-)-(3S,4R)-4-(p-Fluorophenyl)-3-((3,4-methylenedioxy)phenoxy)-methyl)piperidine hydrochloride
(-)-trans-4-(-4-fluorophenyl)-3-(3,4-methylenedioxy-phenoxymethyl)-piperidine hydrochloride
(-)-trans-4-(-4-fluorophenyl)-3-(3,4-methylenedioxyphenoxymethyl)-piperidine hydrochloride
(-)-trans-4-(4-fluorophenyl)-3-(3,4-methylene dioxyphenoxymethyl)-piperidine hydrochloride
(-)-trans-paroxetine hydrochloride
(-)TRANS-3-[(1,3-BENZODIOXOL-5-YLOXY) METHYL]-4-(4-FLUOROPHENYL) PAROXETINE HYDROCHLORIDE
(3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-piperidine hydrochloride
(3S-TRANS)-3-[(1,3-BENZODIOXOL-5-YLOXY)METHYL]-4-(4-FLUOROPHENYL)PIPERIDINE HYDROCHLORIDE
(3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride; Paroxetine Hydrochloride Anhydrous; (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; 3-[(1,3-benzodioxol-5-yl
(3S,4R)-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine Hydrochloride
(3S,4R)-3-((BENZO[D][1,3]DIOXOL-5-YLOXY)METHYL)-4-(4-FLUOROPHENYL)PIPERIDINE HCL
(3S,4R)-3-((Benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine hydrochloride
(3S,4R)-3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine hydrochloride
(3S,4R)-3-[(1,3-BENZODIOXOL-5-YLOXY)METHYL]-4-(4-FLUOROPHENYL)-PIPERIDINE HYDROCHLORIDE
(3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride
(S)-3-(BENZO[1,3]DIOXOL-5-YLOXYMETHYL)-4-(4-FLUORO-PHENYL)-PIPERIDINE HYDROCHLORIDE
110429-35-1
110429-35-1(hemihydrate) 61869-08-7
3I3T11UD2S
61869-08-7 (Parent)
78246-49-8
AB0008509
AB1004558
AC1L1XYV
AK-49032
AKOS015849162
AKOS015907108
AN-15600
ANW-49202
API0003757
Aropax 20
AX8022605
BG0380
BR-49032
BRL 29060 hydrochloride
BRL 29060A
BRL29060A
C19H20FNO3.HCl
C19H21ClFNO3
CCG-39866
CHEBI:7944
CHEMBL1708
CS-2611
D05374
DTXSID50228914
EU-0100095
GELRVIPPMNMYGS-RVXRQPKJSA-N
H29P351
HMS1922B11
HSDB 7175
HY-B0492
J10285
KS-00000JOT
KS-5097
LP00095
LS-114251
MFCD03658863
MLS002222322
MolPort-003-666-523
NCGC00093597-01
NCGC00260780-01
NSC-758654
NSC758654
P1977
Paroxat
paroxatene
PAROXETIN HYDROCHLORIDE
paroxetine (hydrochloride)
paroxetine (Paxil)
Paroxetine Hcl
Paroxetine hydrochloride (USP)
Paroxetine hydrochloride [USAN]
Paroxetine hydrochloride [USP]
Paroxetine hydrochloride hemihydrate
Paroxetine hydrochloride hemihydrate (MW = 374.83)
Paroxetine or other medication - algorithm used
paroxetinehydrochloride
Pharmakon1600-01504085
Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride, (3S-trans)-
Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride, (3S,4R)-
Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride,(3S-trans)-
S-2491
S3005
SCHEMBL33348
SDB 7175
SMR001307264
SPECTRUM1504085
ST24025708
ST51054156
TC-137947
TL8005348
Tox21_500095
UNII-3I3T11UD2S
YF10047
Z1741971218
Tentative approvals for PAROXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 30MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 20MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 10MG BASETABLET;ORAL

US Patents and Regulatory Information for paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854-002 Oct 31, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078194-003 Jun 29, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jubilant Generics PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 205528-004 Nov 27, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076618-002 Aug 15, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077082-002 Jun 29, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 204134-001 Jan 20, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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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Expired US Patents for paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Army
Fish and Richardson
QuintilesIMS
Accenture
Colorcon
Medtronic
Moodys
UBS

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