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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Chubb
US Department of Justice
Moodys
Fuji
Colorcon
Federal Trade Commission
Teva

Generated: July 15, 2018

DrugPatentWatch Database Preview

GALANTAMINE HYDROBROMIDE - Generic Drug Details

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What are the generic drug sources for galantamine hydrobromide and what is the scope of galantamine hydrobromide patent protection?

Galantamine hydrobromide
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharma Global, Watson Labs, Janssen Pharms, West-ward Pharms Int, Actavis Elizabeth, Apotex Inc, Dr Reddys Labs Ltd, Sandoz, Teva Pharms, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Galantamine hydrobromide has forty-four patent family members in thirty-five countries.

There are fifteen drug master file entries for galantamine hydrobromide. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for GALANTAMINE HYDROBROMIDE
Medical Subject Heading (MeSH) Categories for GALANTAMINE HYDROBROMIDE
Synonyms for GALANTAMINE HYDROBROMIDE
(+/-)-Galantamine hydrobromide
(+/-)-Galanthamine hydrobromide
(1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0^{1,12}.0^{6,17}]heptadeca-6(17),7,9,15-tetraen-14-ol hydrobromide
(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 hydrobromide
(4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol hydrobromide
(4aS,6R,8aS)-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide
1,2,3,4,6,7,7a,11c-Octahydro-9-methoxy-2-methyl-benzofuro(4,3,2-efg)(2)benzazocin-6-ol HBr
193146-85-9
1953-04-4
4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, hydrobromide (1:1), (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-, hydrobromide (1:1), (4aS,6R,8aS)-
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, hydrobromide, (4aalpha,6beta,8ar*)-
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, hydrobromide, (4aS,6R,8aS)-
6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-,hydrobromide, (4aS,6R,8aS)-
953G044
AC-469
AC1L3T0P
AC1Q23LL
AK146319
AKOS007930166
AKOS015960209
Ambap1953-04-4
anti-Alzheimer
AS-12155
BC200303
Benzofuro(4,3,2-efg)(2)benzazocin-6-ol, 1,2,3,4,6,7,7a,11c-octahydro-9-methoxy-2-methyl-, hydrobromide
C17H22BrNO3
CCG-38829
CG0027
CHEMBL1555
CPD000449267
CS-0378
D02173
DTXSID4052768
EINECS 217-780-5
FT-0082629
G0293
Galantamine hydrobromide (JAN/USAN)
Galantamine hydrobromide (racemic)
Galantamine hydrobromide [USAN:USP]
Galantamine hydrobromide [USAN]
Galantamine hydrobromide, (+/-)-
Galanthamine (hydrobromide)
Galanthamine HBr
Galanthamine hydrobromide
Galanthamine hydrobromide from Lycoris sp., >=94% (TLC)
Galanthamine hydrogen bromide
GALANTHAMINEHYDROBROMIDE
galanthaminhydrobromid(1:1)
GP-37267
HMS1569F18
HMS1921P21
HY-A0009
J10353
Jilcon hydrobromide
LS-185021
LS-35389
Lycoremine hydrobromide
MCULE-7403371703
MFCD00067672
MJ4PTD2VVW
MLS000758283
MLS001401401
MolPort-003-665-621
NC00061
Nivalin
Nivaline (C17 pharmaceutical)
Nivaline (pharmaceutical)
Prestwick_236
PubChem13654
QORVDGQLPPAFRS-XPSHAMGMSA-N
R-113675
Razadyne
Razadyne (TN)
Reminyl XL
Reminyl, 69353-21-5
s1339
SAM001246978
SCHEMBL177993
SMR000449267
SPECTRUM1501202
ST24047324
UNII-5N4SA4KQX9 component QORVDGQLPPAFRS-XPSHAMGMSA-N
UNII-MJ4PTD2VVW
W-5061
Z1558572528
Tentative approvals for GALANTAMINE HYDROBROMIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up4MGTABLET; ORAL
➤ Sign Up➤ Sign Up12MGTABLET; ORAL
➤ Sign Up➤ Sign Up8MGTABLET; ORAL

US Patents and Regulatory Information for GALANTAMINE HYDROBROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077593-002 Sep 11, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077603-002 Aug 28, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Yabao Pharm GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077604-001 Feb 6, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077605-003 Aug 28, 2008 AB RX 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 GALANTAMINE HYDROBROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for GALANTAMINE HYDROBROMIDE

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:

Baxter
Express Scripts
QuintilesIMS
US Department of Justice
UBS
Healthtrust
Harvard Business School
Argus Health
Fish and Richardson

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