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Last Updated: November 13, 2019

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RAZADYNE Drug Profile

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Which patents cover Razadyne, and what generic alternatives are available?

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

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Drug patent expirations by year for RAZADYNE
Drug Prices for RAZADYNE

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Recent Clinical Trials for RAZADYNE

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

SponsorPhase
Vanderbilt University Medical CenterPhase 1
Doris Duke Charitable FoundationPhase 1/Phase 2
Vanderbilt UniversityPhase 1/Phase 2

See all RAZADYNE clinical trials

Recent Litigation for RAZADYNE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Pharmaceutica N V v. Sandoz Inc.2008-08-13
ELI LILLY AND COMPANY v. ACTAVIS ELIZABETH LLC2007-08-09
The Holmes Group, Inc. v. West Bend Housewares, LLC2005-06-28

See all RAZADYNE litigation

Pharmacology for RAZADYNE
Synonyms for RAZADYNE
(-)-Galantamine
(-)-Galanthamine
(-)Galanthamine
(+/-)-Galantamine
(+/-)-Galanthamine
(1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0^{1,12}.0^{6,17}]heptadeca-6,8,10(17),15-tetraen-14-ol
(1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0;{1,12}.0;{6,17}]heptadeca-6,8,10(17),15-tetraen-14-ol
(1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol
(4aS,6R,8aS)-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol
(4aS,6R,8aS)-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol
(4aS,6R,8aS)-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofurol[3a,3,2,-ef][2]benzazepin-6-ol
0D3Q044KCA
1008759-59-8
1354-74-1
1551-02-6
1dx6
1qti
23173-12-8
27501-22-0
357-70-0
357G700
4-27-00-02184 (Beilstein Handbook Reference)
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aalpha,6beta,8ar*)-
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aR,6S,8aR)-rel-
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)-
6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)-
6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-ol,4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)-
736-79-8
AB00053614_10
AB00053614-09
AC-20240
AC1L1TIM
AJ-23165
AKOS015965330
AM62710
AN-133
AN-44509
ASUTZQLVASHGKV-JDFRZJQESA-
ASUTZQLVASHGKV-JDFRZJQESA-N
BCP28966
BDBM10404
BIDD:GT0517
Bodamine
BPBio1_000480
BRD-K49481516-004-03-5
BRD-K49481516-004-04-3
BRD-K49481516-004-09-2
BRN 0093736
BSPBio_000436
BSPBio_003416
C08526
CAS-357-70-0
CCG-212961
CG0028
CHEBI:42944
CHEMBL659
CS-1217
CTK8F9985
D04292
DB00674
DivK1c_000590
DSSTox_CID_25606
DSSTox_GSID_45606
DSSTox_RID_80999
DTXSID2045606
Galantamin
Galantamin(NSC 100058)
Galantamina
Galantamina [INN-Spanish]
Galantamine
Galantamine (USAN/INN)
Galantamine [USAN:INN:BAN]
Galantamine [USAN:INN]
Galantamine, (+/-)-
Galantaminum
Galantaminum [INN-Latin]
galanthamine
Galanthamine base
Galanthamine HBr
Galanthamine, (+/-)-
Galanthamine, 12
Galanthaminum
GNT
GTPL6693
HMS2089H03
HSDB 7361
HY-76299
IDI1_000590
InChI=1/C17H21NO3/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17/h3-6,12,14,19H,7-10H2,1-2H3/t12-,14-,17-/m0/s1
Jilkon
KBio1_000590
KBio2_001751
KBio2_004319
KBio2_006887
KBio3_002636
KBioGR_001417
KBioSS_001751
KS-000000IN
LS-71039
Lycoremin
Lycoremine
MCULE-7156449246
MCULE-7226205054
MolPort-002-521-885
NCGC00017256-04
NCGC00017256-05
NCGC00017256-11
NCGC00024731-02
NINDS_000590
Nivalin
NSC 100058
NSC-759861
NSC759861
Pharmakon1600-01501202
Prestwick0_000588
Prestwick1_000588
Prestwick2_000588
Prestwick3_000588
Probes1_000055
Probes2_000395
Razadyne ER
Reminyl (TN)
SBI-0051689.P002
SCHEMBL2577
SCHEMBL3293474
SDCCGMLS-0066737.P001
SMP1_000131
SPBio_002655
Spectrum_001271
Spectrum3_001738
Spectrum4_000839
Spectrum5_001673
SR-05000001783
SR-05000001783-4
Tox21_110807
UNII-0D3Q044KCA
UNII-1T835Z585R component ASUTZQLVASHGKV-JDFRZJQESA-N
W-5162
ZINC491073
Paragraph IV (Patent) Challenges for RAZADYNE
Tradename Dosage Ingredient NDA Submissiondate
RAZADYNE TABLET;ORAL galantamine hydrobromide 021169 2005-02-28

US Patents and Regulatory Information for RAZADYNE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms RAZADYNE galantamine hydrobromide SOLUTION;ORAL 021224-001 Jun 22, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 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 RAZADYNE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide SOLUTION;ORAL 021224-001 Jun 22, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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