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QUDEXY XR Drug Profile

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

Qudexy Xr is a drug marketed by Upsher-smith Labs and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in QUDEXY XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for QUDEXY XR

International Patents:	7
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	69
Patent Applications:	4,293
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUDEXY XR
DailyMed Link:	QUDEXY XR at DailyMed

Pharmacology for QUDEXY XR

Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Synonyms for QUDEXY XR

((3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyltetrahydro-3aH-bis([1,3]dioxolo)[4,5-b:4',5'-d]pyran-3a-yl)methyl sulfamate

((3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyltetrahydro-3aH-bis[1,3]dioxolo[4,5-b:4',5'-d]pyran-3a-yl)methyl sulfamate

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0^{2,6}]dodecan-6-yl]methyl sulfamate

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0;{2,6}]dodecan-6-yl]methyl sulfamate

[(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate

[(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[5,4-b:5',3'-d]pyran-3a-yl]methyl sulfamate

[(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyltetrahydro-3aH-bis[1,3]dioxolo[4,5-b:4',5'-d]pyran-3a-yl]methyl sulfamate

0H73WJJ391

2,?3:4,?5-?BIS-?O-?(1-?METHYLETHYLIDENE)-?BETA-?D-?FRUCTOPYRANOSE 1-?SULFAMATE

2,3-4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

2,3:4,5-Bis-O-(1-methylethylidene) .beta.-D-fructopyranose sulfamate

2,3:4,5-Bis-O-(1-methylethylidene)-?-D-fructopyranose sulfamate

2,3:4,5-Bis-O-(1-methylethylidene)-36-D-fructo-pyranose sulfamate

2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

2,3:4,5-Di- O -isopropylidene-(beta)-D-fructopyranose sulfamate

2,3:4,5-di-o-isopropylidene-(beta)-d-fructopyranose sulfamate

2,3:4,5-Di-O-isopropylidene-b-D-fructopyranose sulfamate

2,3:4,5-Di-O-isopropylidene-beta-D-fructopyranose sulfamate

240T794

3hku

3lxe

5H-Bis[1,3]dioxolo[4,5-b:4',5'-d]pyran, beta

97240-79-4

AB0007831

AB00639961_09

AB00639961_10

AB00639961-06

AB00639961-08

AB1009630

ACT09031

AK163578

AKOS000424547

ALBB-022457

AN-14917

API0004451

BDBM10887

beta-D-Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, sulfamate

Beta-D-Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, sulfamate (9CI)

beta.-D-Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, 1-sulfamate

BIDD:GT0854

BIDD:PXR0127

BRN 5988957

BSPBio_002306

C-20295

C07502

C12H21NO8S

CA004198

CA012560

CAS-97240-79-4

CBChromo1_000352

CC-35104

CCG-100940

CHEBI:63631

CHEMBL220492

Cilag brandof topiramate

CPD000466325

CS-1885

D00537

D07VDZ

DB00273

DR001668

DSSTox_CID_3688

DSSTox_GSID_23688

DSSTox_RID_77148

DTXSID8023688

Epitoma

Epitomax

FRU009

GTPL6849

HMS1922H06

HMS2051L09

HMS2093D20

HMS2232H21

HSDB 7531

HY-B0122

Janssen brand of topiramate

KB-61804

KJADKKWYZYXHBB-XBWDGYHZSA-N

KM3440

KS-1122

KW-6485

LS-187392

LS-69764

McN 4853

McN-4853

MCULE-9403222429

MFCD00865320

MLS000759431

MLS001424070

MolPort-001-615-062

NC00190

NCGC00095181-01

NCGC00178714-01

NCGC00178714-04

NCGC00255221-01

NSC-759251

NSC759251

Ortho brand of topiramate

Pharmakon1600-01505801

Q-201845

RWJ 17021

RWJ-17021

RWJ-17021-000

s1438

SAM001246601

SBI-0206907.P001

SC-16371

SCHEMBL34631

SMR000466325

SPBio_000995

SPECTRUM1505801

Spectrum2_001128

STOCK1N-71037

Sulfamate 7

Tipiramate

Tipiramate [French]

Tipiramato

Tipiramato [Spanish]

TL8006021

Topamac

Topamax

Topamax (TN)

Topamax Sprinkle

Topamax, Topiramate

Topax

Topimax

Topina

Topiragen

topiramate

Topiramate (JAN/USAN/INN)

Topiramate (TPM)

Topiramate [USAN:BAN:INN]

Topiramate [USAN:USP:INN:BAN]

Topiramate / Placebo

Topiramate 1.0 mg/ml in Acetonitrile

topiramate tablet

Topiramate, >=98% (HPLC), solid

Topiramate, pharmaceutical secondary standard: traceable to USP

Topiramate, United States Pharmacopeia (USP) Reference Standard

Topiramato

Topiramato [INN-Spanish]

Topiramatum

Topiramatum [INN-Latin]

topiramatum [Latin]

Topiramic acid

Topomax

TOR

Tox21_111472

Tox21_111472_1

Tox21_302401

Trokendi XR

Trokendi xr (TN)

UNII-0H73WJJ391

USL 255

USL-255

USL255

W-60376

Z1522553470

ZINC95616603

US Patents and Regulatory Information for QUDEXY XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher-smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014		RX	Yes	No			Y
Upsher-smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014		RX	Yes	Yes			Y
Upsher-smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014		RX	Yes	No			Y
Upsher-smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014		RX	Yes	No			Y

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Paragraph IV (Patent) Challenges for QUDEXY XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Capsules	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg

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International Patents for QUDEXY XR

Country	Document Number	Estimated Expiration
European Patent Office	2968177
Israel	241053
South Korea	20160124930
South Korea	101674509

Supplementary Protection Certificates for QUDEXY XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718