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Last Updated: August 14, 2020

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Galantamine hydrobromide - Generic Drug Details

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What are the generic sources for galantamine hydrobromide and what is the scope of freedom to operate?

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, Hikma, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for galantamine hydrobromide

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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

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
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
Yabao Pharm GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077604-003 Feb 6, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077593-001 Sep 11, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma GALANTAMINE HYDROBROMIDE galantamine hydrobromide SOLUTION;ORAL 078185-001 Jan 30, 2009 RX No Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 090957-001 Mar 29, 2011 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 021615-003 Apr 1, 2005   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001   Start Trial   Start Trial
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 021169-003 Feb 28, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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