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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Medtronic
Fuji
Cerilliant
Cipla
Chinese Patent Office
Johnson and Johnson
Daiichi Sankyo
Fish and Richardson
Dow
Harvard Business School

Generated: November 17, 2017

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

Galantamine hydrobromide has eighty-eight patent family members in thirty-five countries and one supplementary protection certificate in one country.

There are fifteen drug master file entries for galantamine hydrobromide. Twenty-one 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

Tentative approvals for GALANTAMINE HYDROBROMIDE

Applicant Application No. Strength Dosage Form
u► Subscribe4MGTABLET; ORAL
u► Subscribe12MGTABLET; ORAL
u► Subscribe8MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yabao Pharm
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077604-003Feb 6, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077587-002Jul 9, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Barr
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL078189-003Sep 15, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077585-003Sep 15, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL090178-001Feb 2, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-003Feb 28, 2001ABRXYesNo► Subscribe► Subscribe ► Subscribe
Watson Labs
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL079028-001Dec 15, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL078484-003May 27, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL204895-001Aug 5, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077603-002Aug 28, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: galantamine hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-001Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-003Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-001Apr 1, 2005► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
SOLUTION;ORAL021224-001Jun 22, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-003Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-001Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-003Apr 1, 2005► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-002Apr 1, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: galantamine hydrobromide

Country Document Number Estimated Expiration
Argentina022008► Subscribe
Australia2100600► Subscribe
China1222077► Subscribe
Slovakia284620► Subscribe
World Intellectual Property Organization (WIPO)9747304► Subscribe
Canada2358062► Subscribe
Slovenia0915701► Subscribe
South Korea100358676► Subscribe
Japan4172820► Subscribe
Spain2235234► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GALANTAMINE HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00140Netherlands► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Express Scripts
Johnson and Johnson
Cantor Fitzgerald
Accenture
Fuji
Chubb
US Army
McKinsey
McKesson

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.

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