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Last Updated: August 11, 2020

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GALANTAMINE HYDROBROMIDE Drug Profile

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When do Galantamine Hydrobromide patents expire, and when can generic versions of Galantamine Hydrobromide launch?

Galantamine Hydrobromide is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc. and is included in nineteen NDAs.

The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

US ANDA Litigation and Generic Entry Outlook for Galantamine Hydrobromide

A generic version of GALANTAMINE HYDROBROMIDE was approved as galantamine hydrobromide by BARR on August 28th, 2008.

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Drug patent expirations by year for GALANTAMINE HYDROBROMIDE
Drug Prices for GALANTAMINE HYDROBROMIDE

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Recent Clinical Trials for GALANTAMINE HYDROBROMIDE

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

See all GALANTAMINE HYDROBROMIDE clinical trials

Pharmacology for GALANTAMINE HYDROBROMIDE
Medical Subject Heading (MeSH) Categories for GALANTAMINE HYDROBROMIDE
Paragraph IV (Patent) Challenges for GALANTAMINE HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 2006-03-11
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 2006-03-02
RAZADYNE TABLET;ORAL galantamine hydrobromide 021169 2005-02-28

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
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077590-001 May 29, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077585-001 Sep 15, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077589-003 Jun 22, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077590-003 May 29, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Yabao Pharm GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077604-001 Feb 6, 2009 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

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