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Last Updated: January 22, 2020

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Paroxetine hydrochloride - Generic Drug Details

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What are the generic sources for paroxetine hydrochloride and what is the scope of freedom to operate?

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 is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Paroxetine hydrochloride has one hundred and fifty-seven patent family members in thirty-eight countries.

There are thirty drug master file entries for paroxetine hydrochloride. Forty suppliers are listed for this compound.

Recent Clinical Trials for paroxetine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical GroupN/A
Noam SoreniPhase 3
Central South UniversityN/A

See all paroxetine hydrochloride clinical trials

Recent Litigation for paroxetine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC.2017-07-06
IN RE SEBELA PATENT LITIGATION2014-10-16
Ferring B v. v. Watson Laboratories Inc.2014-04-17

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,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
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 (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)-
S-2491
S3005
SCHEMBL33348
SDB 7175
SMR001307264
SPECTRUM1504085
SR-01000759305
SR-01000759305-6
ST24025708
SW197457-4
TC-137947
TL8005348
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
Teva PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076618-003 Aug 15, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078194-002 Jun 29, 2007 DISCN 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

Expired US Patents for paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Dow
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Colorcon

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