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BRISDELLE Drug Profile

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When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?

Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in thirty-two countries.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

Summary for BRISDELLE

International Patents:	63
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	9
Clinical Trials:	4
Patent Applications:	75
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRISDELLE
DailyMed Link:	BRISDELLE at DailyMed

Pharmacology for BRISDELLE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Synonyms for BRISDELLE

(-)-(3S,4R)-4-(p-Fluorophenyl)-3-((3,4-(methylenedioxy)phenoxy)methyl)piperidine

(-)-(3S,4R)-4-(p-Fluorophenyl)-3-((3,4-methylenedioxy)phenoxy)methyl)piperidine

(-)-Paroxetine

(-)-trans-4-(4-Fluorophenyl)-3-(3,4-methylenedioxyphenoxymethyl)piperidine

(-)-trans-4-(p-fluorophenyl)-3-[[3,4-(methylenedioxy)phenoxy]methyl]-piperidine

(3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine

(3S-trans)-3-[(1,3-Benzodioxol-5-yl-oxy)methyl]-4-(4-fluorophenyl)piperidine

(3s,4r)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine

(3S,4R)-3-((Benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine methanesulfonate

(3S,4R)-3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine

(3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine

(3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine

[3H]Paroxetine

110429-35-1

110429-35-1 (HCl hemihydrate)

217797-14-3

3-(Benzo[1,3]Dioxol-5-Yl-Oxymethyl)-4-(4-Fluoro-Phenyl)-Piperidine Hydrochloride

3h-paroxetine

41VRH5220H

61869-08-7

63952-24-9

64006-44-6 (maleate)

72471-80-8 (acetate)

78246-49-8 (hydrochloride)

869P087

8PR

AB00053704_22

AB00053704_23

AB00053704-21

AB00514724

AC-8185

AC1L2AKL

AC1Q1H18

AC1Q4LV6

AHOUBRCZNHFOSL-YOEHRIQHSA-N

AJ-23329

AK310474

AK501459

AKOS015888636

AKOS027321054

AN-8247

Aropax

BDBM22416

BDBM50331515

BIDD:GT0673

BPBio1_000949

BRD-K37991163-003-02-7

Brisdelle (TN)

BRL 29060

BRL-29060

BRL-29060A

BSPBio_000861

C-19975

C07415

C19H20FNO3

CAS-61869-08-7

Casbol

CC-33477

CHEBI:7936

CHEMBL1200609

CHEMBL1708

CHEMBL490

D02362

D05375

D06GDY

D06VML

DB00715

DivK1c_006884

DR001531

DSSTox_CID_3425

DSSTox_GSID_23425

DSSTox_RID_77022

DTXSID3023425

FG 7051

FG-7051

Frosinor

FT-0085087

GTPL4790

HE295209

HMS2090H05

HSDB 7175

I14-7752

KB-277026

KB-302613

KBio1_001828

KBio2_002232

KBio2_004800

KBio2_007368

KBioSS_002232

KS-00000JK2

LDMP

LS-114249

M711N184JE

MolPort-003-849-791

Motivan

NCGC00025355-02

NCGC00025355-03

NCGC00025355-04

NCGC00025355-05

NCGC00025355-06

NCGC00025355-07

NCGC00025355-08

NCGC00025355-09

NCGC00025355-12

NCGC00182968-01

NNC-20-7051

Paroxetin HCL

Paroxetina

Paroxetina [INN-Spanish]

paroxetine

Paroxetine (TN)

Paroxetine (USP/INN)

Paroxetine [USAN:INN:BAN]

Paroxetine Hcl

PAROXETINE HCL HEMIHYDRATE

paroxetine hydrochloride (anhydrous or hemihydrate)

Paroxetine Hydrochloride Anhydrous

Paroxetine hydrochloride hemihydrate

Paroxetine hydrochloride hydrate

Paroxetine Mesilate

Paroxetine Mesylate

Paroxetine mesylate (USAN)

Paroxetine Mesylate [USAN]

Paroxetine methanesulphonate

Paroxetine.HCl

Paroxetinum

Paroxetinum [INN-Latin]

Paxetil

Paxil

Paxil (TN)

Paxil CR

Paxil, Pexeva

PaxPar

Pexeva

Pexeva (TN)

Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, (3S-trans)-

Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, (3S,4R)-

Piperidine, 3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, (3S-trans)-

piperidine, 3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, (3S,4R)-

Piperidine,3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, (3S,4R)-

Piperidine,3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-,(3S,4R)-

POT.mes

Prestwick3_000851

SBI-0051908.P002

SC-16100

SC-22977

SCHEMBL143905

SCHEMBL27799

Seroxat

Seroxat (TN)

Seroxat CR

SHIJTGJXUHTGGZ-RVXRQPKJSA-N

SpecPlus_000788

Spectrum_001752

Spectrum5_001665

TL8003967

Tox21_113123

Tox21_113123_1

UNII-41VRH5220H

UNII-M711N184JE

ZINC527386

US Patents and Regulatory Information for BRISDELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes			Y	Y
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes				Y
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes			Y	Y
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes

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Expired US Patents for BRISDELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013

Paragraph IV (Patent) Challenges for BRISDELLE

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	7.5 mg		2014-04-07

Non-Orange Book US Patents for BRISDELLE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,805,270	Video segmentation techniques
5,874,447	4-Phenylpiperidine compounds for treating depression
9,436,876	Video segmentation techniques
8,859,576	Method of treating thermoregulatory dysfunction with paroxetine

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International Patents for BRISDELLE

Country	Document Number	Estimated Expiration
South Korea	20090040453
Canada	2659577
Brazil	9714787
World Intellectual Property Organization (WIPO)	2008019010