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Generated: September 21, 2018

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GALANTAMINE HYDROBROMIDE - Generic Drug Details

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What are the generic 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.

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 Up12MGTABLET; ORAL
➤ Sign Up➤ Sign Up8MGTABLET; ORAL
➤ Sign Up➤ Sign Up4MGTABLET; 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
Watson Labs GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 079028-001 Dec 15, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077590-001 May 29, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077587-002 Jul 9, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077589-002 Jun 22, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 078189-001 Sep 15, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077608-002 Feb 11, 2009 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 021169-003 Feb 28, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 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 021169-001 Feb 28, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide SOLUTION;ORAL 021224-001 Jun 22, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 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:

Accenture
Colorcon
Cipla
Chubb
Mallinckrodt
US Department of Justice
Boehringer Ingelheim
Argus Health
Federal Trade Commission

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.