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, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Janssen Pharms, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, 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. Thirteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for galantamine hydrobromide

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	22
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	22
Drug Prices:	Drug price trends for galantamine hydrobromide
What excipients (inactive ingredients) are in galantamine hydrobromide?	galantamine hydrobromide excipients list
DailyMed Link:	galantamine hydrobromide at DailyMed

See drug prices for galantamine hydrobromide

Recent Clinical Trials for galantamine hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Duke University	Phase 4
Ortho-McNeil Neurologics, Inc.	Phase 4

See all galantamine hydrobromide clinical trials

Generic filers with tentative approvals for GALANTAMINE HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	4MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	12MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	8MG	TABLET; 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

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for galantamine hydrobromide

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for galantamine hydrobromide

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	090900-001	Jan 24, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077608-002	Feb 11, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077608-001	Feb 11, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yabao Pharm	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	TABLET;ORAL	077604-001	Feb 6, 2009	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	078484-003	May 27, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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