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Cantor Fitzgerald
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Covington
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Cipla
Harvard Business School
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Generated: August 21, 2018

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PAXIL Drug Profile

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

Paxil is a drug marketed by Apotex Technologies and is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and fifty-eight patent family members in thirty-eight countries.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Drug patent expirations by year for PAXIL
Pharmacology for PAXIL
Synonyms for PAXIL
(-)-(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
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

US Patents and Regulatory Information for PAXIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 AB RX Yes 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 PAXIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for PAXIL
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 37.5 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 25 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Oral Suspension 10 mg/5 mL ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Healthtrust
Express Scripts
Mallinckrodt
Accenture
Federal Trade Commission
Chinese Patent Office
Chubb
Fuji

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