Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Express Scripts

Last Updated: December 15, 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the topiramate profile page.

US ANDA Litigation and Generic Entry Outlook for Topamax

A generic version of TOPAMAX was launched as topiramate by ACCORD HLTHCARE on December 15th, 2019.

Drug patent expirations by year for TOPAMAX
Drug Prices for TOPAMAX

See drug prices for TOPAMAX

Drug Sales Revenue Trends for TOPAMAX

See drug sales revenues for TOPAMAX

Recent Clinical Trials for TOPAMAX

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

SponsorPhase
University of Colorado- Nutrition Obesity Research CenterPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Jaime Moore, MD MPHPhase 2

See all TOPAMAX clinical trials

Recent Litigation for TOPAMAX

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16
ORTHO-MCNEIL PHARMACEUTICAL, INC. v. MYLAN LABORATORIES INC.

See all TOPAMAX litigation

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
Paragraph IV (Patent) Challenges for TOPAMAX
Tradename Dosage Ingredient NDA Submissiondate
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 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   Start Trial   Start Trial Y   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 AB RX Yes 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 TOPAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-003 Dec 24, 1996   Start Trial   Start Trial
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Mallinckrodt
Johnson and Johnson
Harvard Business School
McKesson

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