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Generated: May 26, 2018

DrugPatentWatch Database Preview

TOPAMAX Drug Profile

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When do Topamax patents expire, and what generic alternatives are available?

Topamax is a drug marketed by Janssen Pharms and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has thirty-nine patent family members in thirty-one countries.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Drug patent expirations by year for TOPAMAX
Synonyms for TOPAMAX
((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 (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 TOPAMAX

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 CAPSULE;ORAL 020844-001 Oct 26, 1998 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-001 Dec 24, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for TOPAMAX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 50 mg ➤ Subscribe 2005-09-08
➤ Subscribe Capsules 15 mg and 25 mg ➤ Subscribe 2005-09-07
➤ Subscribe Tablets 25 mg, 100 mg and 200 mg ➤ Subscribe 2001-12-26

Non-Orange Book US Patents for TOPAMAX

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
6,696,091 Pharmaceutical composition of topiramate ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TOPAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/028 United Kingdom ➤ Sign Up 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:

Julphar
Daiichi Sankyo
Fuji
Express Scripts
Teva
Queensland Health
AstraZeneca
Covington
Cerilliant

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