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Generated: December 12, 2018

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RAZADYNE ER Drug Profile

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

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

This drug has forty-four patent family members in thirty-five countries.

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

Drug patent expirations by year for RAZADYNE ER
Pharmacology for RAZADYNE ER
Medical Subject Heading (MeSH) Categories for RAZADYNE ER
Synonyms for RAZADYNE ER
(-)-Galantamine
(-)-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[8.6.1.0(1),(1)(2).0?,(1)?]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),(1)(2).0?,(1)?]HEPTADECA-6(17),7,9,15-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
AK198672
AKOS015965330
AM62710
AN-133
AN-44509
ASUTZQLVASHGKV-JDFRZJQESA-
ASUTZQLVASHGKV-JDFRZJQESA-N
BDBM10404
BIDD:GT0517
Bodamine
BPBio1_000480
BRD-K49481516-004-03-5
BRD-K49481516-004-04-3
BRN 0093736
BSPBio_000436
BSPBio_003416
C08526
CAS-357-70-0
CCG-212961
CG0028
CHEBI:42944
CHEMBL659
CS-1217
CTK8F9985
D04292
D0R9VR
DB00674
DivK1c_000590
DR001054
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
NCGC00024731-02
NINDS_000590
Nivalin
Nivalin (TN)
NSC 100058
NSC-759861
NSC759861
Pharmakon1600-01501202
PL001680
PL054958
Prestwick0_000588
Prestwick1_000588
Prestwick2_000588
Prestwick3_000588
Probes1_000055
Probes2_000395
Razadyne
Razadyne (TN)
Razadyne ER (TN)
Reminyl
Reminyl (TN)
SBI-0051689.P002
SCHEMBL2577
SCHEMBL3293474
SDCCGMLS-0066737.P001
SMP1_000131
SPBio_002655
Spectrum_001271
Spectrum3_001738
Spectrum4_000839
Spectrum5_001673
STOCK1N-46108
Tox21_110807
UNII-0D3Q044KCA
UNII-1T835Z585R component ASUTZQLVASHGKV-JDFRZJQESA-N
W-5162
ZINC491073

US Patents and Regulatory Information for RAZADYNE ER

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 ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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 RAZADYNE ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 ➤ 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 RAZADYNE ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 16 mg and 24 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 8 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for RAZADYNE ER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00140 Netherlands ➤ Sign Up PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Julphar
Harvard Business School
US Army
Colorcon
Baxter
UBS
Fuji
Dow

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