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Last Updated: March 19, 2024

Galantamine hydrobromide - Generic Drug Details


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What are the generic drug 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, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Janssen Pharms, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, 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 twelve drug master file entries for galantamine hydrobromide. Twelve 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
⤷  Try a Trial⤷  Try a Trial12MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial8MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
RAZADYNE ER Extended-release Capsules galantamine hydrobromide 16 mg and 24 mg 021615 1 2006-03-11
RAZADYNE ER Extended-release Capsules galantamine hydrobromide 8 mg 021615 1 2006-03-02
RAZADYNE Tablets galantamine hydrobromide 4 mg, 8 mg and 12 mg 021169 14 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
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharma GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077585-002 Sep 15, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 090957-002 Mar 29, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077603-002 Aug 28, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 090900-001 Jan 24, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 078484-003 May 27, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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