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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.

Summary for paroxetine hydrochloride

International Patents:	157
US Patents:	1
Tradenames:	4
Applicants:	18
NDAs:	23
Drug Master File Entries:	30
Suppliers / Packagers:	54
Bulk Api Vendors:	85
Clinical Trials:	229
Patent Applications:	1,209
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paroxetine hydrochloride
DailyMed Link:	paroxetine hydrochloride at DailyMed

Pharmacology for paroxetine hydrochloride

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

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
		EQ 40MG BASE	TABLET;ORAL
		EQ 30MG BASE	TABLET;ORAL
		EQ 20MG BASE	TABLET;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
Prinston Inc	PAROXETINE	paroxetine hydrochloride	TABLET;ORAL	203854-003	Oct 31, 2014	AB	RX	No	No
Teva Pharms	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	077082-004	Jun 29, 2007		DISCN	No	No
Teva Pharms	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	077082-002	Jun 29, 2007		DISCN	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-001	Mar 13, 2008	AB	RX	No	No

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
Apotex Technologies	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999
Apotex Technologies	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998
Apotex Technologies	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997
Apotex Technologies	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998

International Patents for paroxetine hydrochloride

Country	Patent Number	Estimated Expiration
Portugal	1089996
Austria	251155
Belgium	1012403
European Patent Office	1020464
Portugal	102291