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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
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McKinsey
Moodys
AstraZeneca

Last Updated: October 23, 2019

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Galantamine hydrobromide - Generic Drug Details

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

Galantamine hydrobromide is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Janssen Pharms, West-ward Pharms Int, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, 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. Seventeen suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for galantamine hydrobromide

See drug prices for galantamine hydrobromide

Recent Clinical Trials for galantamine hydrobromide

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

SponsorPhase
Vanderbilt University Medical CenterPhase 1
Ortho-McNeil Neurologics, Inc.Phase 4
Duke UniversityPhase 4

See all galantamine hydrobromide clinical trials

Recent Litigation for galantamine hydrobromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Pharmaceutica N V v. Sandoz Inc.2008-08-13
Janssen L P v. KV Pharmaceutical Company2007-12-18
ELI LILLY AND COMPANY v. ACTAVIS ELIZABETH LLC2007-08-09

See all galantamine hydrobromide litigation

Generic filers with tentative approvals for GALANTAMINE HYDROBROMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12MGTABLET; ORAL
  Start Trial  Start Trial8MGTABLET; ORAL
  Start Trial  Start Trial4MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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)-
953G044
AC-469
AC1L3T0P
AC1Q23LL
AK146319
AKOS007930166
AKOS015960209
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 Hydrobromide,(S)
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
Reminyl (TN)
Reminyl XL
Reminyl, 69353-21-5
s1339
SAM001246978
SCHEMBL177993
SMR000449267
SPECTRUM1501202
SR-01000597844
SR-01000597844-1
SR-01000597844-5
SR-05000001783
SR-05000001783-3
ST24047324
UNII-5N4SA4KQX9 component QORVDGQLPPAFRS-XPSHAMGMSA-N
UNII-MJ4PTD2VVW
W-5061
Z1558572528

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
Heritage Pharma GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077585-001 Sep 15, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int GALANTAMINE HYDROBROMIDE galantamine hydrobromide SOLUTION;ORAL 078185-001 Jan 30, 2009 RX No Yes   Start Trial   Start Trial   Start Trial
Apotex Inc GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077781-002 Sep 27, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 078484-001 May 27, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 204895-003 Aug 5, 2016 AB RX No 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 galantamine hydrobromide

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   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for galantamine hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0236684 C300140 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Medtronic
McKinsey
Baxter
Moodys

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