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Generated: September 19, 2019

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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 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
[(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 (TN)
Topamax Sprinkle
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 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

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
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 AB RX Yes 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 CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 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 TABLET;ORAL 020505-003 Dec 24, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 ➤ 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 Date
➤ Subscribe Tablets 50 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 15 mg and 25 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 25 mg, 100 mg and 200 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for TOPAMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138441 SPC/GB95/028 United Kingdom ➤ Sign Up PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Baxter

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.