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Last Updated: May 28, 2020

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PAROXETINE HYDROCHLORIDE Drug Profile


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

Paroxetine Hydrochloride is a drug marketed by Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma 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 eighteen NDAs.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Paroxetine Hydrochloride

A generic version of PAROXETINE HYDROCHLORIDE was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.

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Drug patent expirations by year for PAROXETINE HYDROCHLORIDE
Recent Clinical Trials for PAROXETINE HYDROCHLORIDE

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SponsorPhase
Spaulding Clinical Research LLCPhase 1
Food and Drug Administration (FDA)Phase 1
Leiden University Medical CenterPhase 1

See all PAROXETINE HYDROCHLORIDE clinical trials

Recent Litigation for PAROXETINE HYDROCHLORIDE

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District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC.2017-07-06
Sebela International Limited v. ACTAVIS LABORATORIES FL, INC.2017-06-28

See all PAROXETINE HYDROCHLORIDE litigation

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 hemihydrate
(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-[(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
78246-49-8
AB0008509
AB1004558
AK-49032
AKOS015849162
AKOS015907108
ANW-49202
API0003757
Aropax
Aropax 20
AX8022605
BG0380
BR-49032
BRL 29060 hydrochloride
BRL 29060A
BRL-29060A
BRL29060 hydrochloride
BRL29060A
C19H20FNO3.HCl
C19H21ClFNO3
CCG-39866
CHEBI:7944
CHEMBL1708
CS-2611
D05374
DTXSID50228914
EU-0100095
FG-7051
GELRVIPPMNMYGS-RVXRQPKJSA-N
H29P351
HMS1922B11
HSDB 7175
HY-B0492
J10285
KS-00000JOT
KS-5097
LP00095
LS-114251
MFCD03658863
MLS002222322
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 Anhydrous
Paroxetine hydrochloride hemihydrate
Paroxetine hydrochloride hemihydrate (MW = 374.83)
Paroxetine or other medication - algorithm used
Paroxetine, HCl
Paxil
Paxil (TN)
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)-
Q27257245
S-2491
S3005
SCHEMBL33348
SDB 7175
Seroxat
SMR001307264
SPECTRUM1504085
SR-01000759305
SR-01000759305-6
ST24025708
SW197457-4
TC-137947
Tox21_500095
UNII-3I3T11UD2S
YF10047
Z1741971218
Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2009-05-19
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2005-09-09
PAXIL SUSPENSION;ORAL paroxetine hydrochloride 020710 2005-02-10
PAXIL CAPSULE;ORAL paroxetine hydrochloride 020885
PAXIL TABLET;ORAL paroxetine hydrochloride 020031

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
Roxane PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078026-004 Jun 29, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075716-003 Mar 8, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Teva PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076618-004 Aug 15, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms Usa PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584-003 Mar 7, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Harvard Business School
Medtronic
AstraZeneca
Johnson and Johnson

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