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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Citi
McKinsey
Colorcon
Chubb
Cipla
Harvard Business School
UBS
Fish and Richardson
Daiichi Sankyo

Generated: August 16, 2017

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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 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-four patent family members in thirty-five countries.

There are fifteen drug master file entries for galantamine hydrobromide. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: galantamine hydrobromide

Tradenames:3
Patents:3
Applicants:15
NDAs:22
Drug Master File Entries: see list15
Suppliers / Packagers: see list20
Bulk Api Vendors: see list53
Clinical Trials: see list147
Patent Applications: see list571
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:galantamine hydrobromide at DailyMed

Pharmacology for Ingredient: galantamine hydrobromide

Tentative approvals for GALANTAMINE HYDROBROMIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe4MGTABLET; ORAL
► Subscribe► Subscribe12MGTABLET; ORAL
► Subscribe► Subscribe8MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077781-002Sep 27, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL090178-001Feb 2, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077585-003Sep 15, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL090957-002Mar 29, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-003Apr 1, 2005ABRXYesNo► Subscribe► SubscribeY ► 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
TABLET;ORAL021169-001Feb 28, 2001► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: galantamine hydrobromide

Country Document Number Estimated Expiration
South Korea100437105► Subscribe
Denmark1140105► Subscribe
African Regional IP Organization (ARIPO)200102219► Subscribe
World Intellectual Property Organization (WIPO)0038686► Subscribe
Ukraine79578► 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 500+ biopharmaceutical companies globally:

Mallinckrodt
Novartis
Moodys
Daiichi Sankyo
Dow
Fish and Richardson
UBS
Julphar
Accenture
Baxter

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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