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Last Updated: November 22, 2019

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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 patent protection?

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

Topiramate has fifty-eight patent family members in thirty-three countries.

There are twenty-six drug master file entries for topiramate. Thirty-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for TOPIRAMATE

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Drug Sales Revenue Trends for TOPIRAMATE

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Recent Clinical Trials for TOPIRAMATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Tongji Hospital, Tongji University School of MedicineN/A
Huadong HospitalN/A
Shanghai Mental Health CenterN/A

See all TOPIRAMATE clinical trials

Recent Litigation for TOPIRAMATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Upsher-Smith Laboratories, Inc. v. Glenmark Pharmaceuticals Limited2017-05-26
Upsher-Smith Laboratories Inc. v. Zydus Pharmaceuticals (USA) Inc.2016-04-11
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16

See all TOPIRAMATE litigation

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;ORAL
  Start Trial  Start Trial50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
[(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 (non-preferred name)
0H73WJJ391
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-b-D-fructopyranose sulfamate
2,3:4,5-Di-O-isopropylidene-beta-D-fructopyranose sulfamate
240T794
3hku
3lxe
97240-79-4
AB0007831
AB00639961_09
AB00639961_10
AB00639961-06
AB00639961-08
AB1009630
ACT09031
AKOS000424547
ALBB-022457
AN-14917
API0004451
BDBM10887
beta-D-Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, sulfamate
BIDD:GT0854
BIDD:PXR0127
BRN 5988957
BSPBio_002306
C-20295
C07502
C12H21NO8S
CAS-97240-79-4
CBChromo1_000352
CC-35104
CCG-100940
CHEBI:63631
CHEMBL220492
CPD000466325
CS-1885
D00537
DB00273
DSSTox_CID_3688
DSSTox_GSID_23688
DSSTox_RID_77148
DTXSID8023688
Epitomax
FRU009
GTPL6849
HMS1922H06
HMS2051L09
HMS2093D20
HMS2232H21
HMS3715I12
HSDB 7531
HY-B0122
KB-61804
KJADKKWYZYXHBB-XBWDGYHZSA-N
KM3440
KS-1122
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
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
SR-01000759409
SR-01000759409-4
Sulfamate 7
SW197570-3
Tipiramate
Tipiramate [French]
Tipiramato
Tipiramato [Spanish]
TL8006021
Topamax
Topamax (TN)
Topamax Sprinkle
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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
topiramate tablet
Topiramate, >=98% (HPLC), solid
Topiramate, 98%
Topiramate, Pharmaceutical Secondary Standard; Certified Reference Material
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
Paragraph IV (Patent) Challenges for TOPIRAMATE
Tradename Dosage Ingredient NDA Submissiondate
QUDEXY XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 205122 2015-12-24
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-05-12
TROKENDI XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 201635 2014-04-03
TOPAMAX TABLET;ORAL topiramate 020505 2005-09-08
TOPAMAX CAPSULE;ORAL topiramate 020844 2005-09-07
TOPAMAX SPRINKLE CAPSULE;ORAL topiramate 020844 2005-09-07
TOPAMAX TABLET;ORAL topiramate 020505 2001-12-26

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
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics TOPIRAMATE topiramate TABLET;ORAL 077627-002 Mar 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Roxane TOPIRAMATE topiramate TABLET;ORAL 076306-004 Mar 27, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Teva TOPIRAMATE topiramate TABLET;ORAL 076317-003 Mar 27, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs TOPIRAMATE topiramate TABLET;ORAL 078499-002 Jan 7, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TOPIRAMATE

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

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Express Scripts
McKesson
Medtronic
Colorcon
McKinsey

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