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Generated: September 26, 2018

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Topiramate - Generic Drug Details

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What are the generic sources for topiramate and what is the scope of topiramate patent protection?

Topiramate is the generic ingredient in five branded drugs marketed by Upsher-smith Labs, Zydus Pharms Usa Inc, Supernus Pharms, Janssen Pharms, Barr, Fosun Pharma, Mylan, Teva, Watson Labs, Accord Hlthcare, Actavis Totowa, Apotex Inc, Aurobindo Pharma, Cipla Ltd, Glenmark Generics, Invagen Pharms, Lupin, Pliva Hrvatska Doo, Roxane, Sun Pharm Inds Ltd, Sun Pharma Global, Torrent Pharms, Unichem Labs Ltd, Wockhardt Usa, and Hikma Pharms, and is included in thirty-three NDAs. There are fourteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for topiramate. Fifty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Synonyms for topiramate
((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
Qudexy XR
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 (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
Tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial200MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial100MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET;ORAL

US Patents and Regulatory Information for topiramate

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 205122-002 Mar 11, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lupin TOPIRAMATE topiramate TABLET;ORAL 078410-004 Sep 11, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-004 Aug 16, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Wockhardt Usa TOPIRAMATE topiramate TABLET;ORAL 090353-002 Sep 1, 2010 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-003 Aug 16, 2013 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-003 Aug 16, 2013 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-004 Aug 16, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for topiramate

Supplementary Protection Certificates for topiramate

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

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Colorcon
Dow
Accenture
Cerilliant
Deloitte
Daiichi Sankyo
Harvard Business School
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.