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Generated: July 16, 2019

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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 paroxetine hydrochloride 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. Fifty-four 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,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
Generic filers with tentative approvals for PAROXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free TrialEQ 40MG BASETABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 30MG BASETABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 20MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Apotex Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride SUSPENSION;ORAL 077395-001 Dec 5, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Prinston Inc PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854-003 Oct 31, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077082-004 Jun 29, 2007 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077082-002 Jun 29, 2007 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902-001 Mar 13, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Citi
QuintilesIMS
Boehringer Ingelheim
Teva

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