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Galantamine hydrobromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for galantamine hydrobromide?

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.

This ingredient has eighty-three patent family members in thirty-five countries.

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.

Summary for Generic Name: galantamine hydrobromide

Tradenames:3
Patents:4
Applicants:15
NDAs:22
Drug Master File Entries: see list15
Suppliers / Packagers: see list21
Bulk Api Vendors: see list50
Clinical Trials: see list45
Patent Applications: see list332
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL4MG
► Subscribe► SubscribeTABLET; ORAL8MG
► Subscribe► SubscribeTABLET; ORAL12MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
SOLUTION;ORAL078185-001Jan 30, 2009RXNoYes► Subscribe► Subscribe
Mylan
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077590-002May 29, 2009RXNoNo► Subscribe► Subscribe
Actavis Elizabeth
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077585-001Sep 15, 2009DISCNNoNo► Subscribe► Subscribe
Yabao Pharm
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL077604-003Feb 6, 2009DISCNNoNo► Subscribe► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-001Feb 28, 2001RXYesYes6,358,527► 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 ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-001Apr 1, 20054,663,318► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-001Feb 28, 20014,663,318► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 20014,663,318► Subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
SOLUTION;ORAL021224-001Jun 22, 20014,663,318► Subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-002Apr 1, 20054,663,318► Subscribe
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International Patent Family for Ingredient: galantamine hydrobromide

Country Document Number Estimated Expiration
African Regional IP Organization (ARIPO)1414► Subscribe
Portugal915701► Subscribe
Japan2002533396► Subscribe
China1331596► Subscribe
Germany69912311► 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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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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