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RAZADYNE ER

NDA

GALANTAMINE HYDROBROMIDE | N021615 | JANSSEN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Exhibit Tabs 1 through 13 FDA-2014-P-1615 · 4 docket documents Spectrum Pharmaceuticals, through Vice President of Regulatory Affairs Cynthia Letizia, filed this petition requesting that the FDA amend the approval date for NDA 21-615 for galantamine hydrobromide extended release capsules (Razadyne ER) in strengths of 8, 16, and 24 mg from December 22, 2004 to A	Other	2014-10-15	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

82 trials from ClinicalTrials.gov, 1 active, 67 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vagal Stimulation in POTS NCT03124355	Phase 1	Active	Vanderbilt University Medical Center	11	2017-09-30 → 2026-12
Galantamine Effects in Patients With Metabolic Syndrome NCT02283242	Phase 4	Completed	University of Sao Paulo	60	2014-03 → 2017-02
Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia NCT00509067	Phase 2	Completed	Georgetown University	43	2007-11 → 2011-03
Galantamine Versus Placebo in Childhood Autism NCT00252603	Phase 3	Completed	University of Medicine and Dentistry of New Jersey	20	2004-04 → 2007-04
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease NCT00814801	Phase 3	Completed	Janssen Pharmaceutical K.K.	580	2007-02 → 2008-09
Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil NCT01478633	Phase 4	Completed	Janssen Pharmaceutical K.K.	102	2011-09 → 2013-06
Discontinuation of Cholinesterase Inhibitors for the Treatment of Severe Alzheimer's Disease NCT02035982	Phase 3	Completed	Sunnybrook Health Sciences Centre	40	2010-07 → 2015-09
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine NCT02420327	N/A	Completed	University of Maryland, Baltimore	43	2014-09 → 2017-03
A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.NCT00077727	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	107	2003-03 → 2005-02
A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease NCT00216502	Phase 3	Completed	Janssen-Cilag S.p.A.	254	2001-08 → 2005-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs7 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

SCINOPHARM TAIWAN LTDGALANTAMINE HYDROBROMIDE USP

DMF 178632004

DR REDDYS LABORATORIES LTDGALANTAMINE HYDROBROMIDE

DMF 180132005

APITORIA PHARMA PRIVATE LTDGALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 219342008

JUBILANT BIOSYS LTDGALANTAMINE HYDROBROMIDE

DMF 219892008

SANOCHEMIA PHARMAZEUTIKA AGGALANTAMINE HYDROBROMIDE

DMF 266432012

SCINOPHARM TAIWAN LTDGALANTAMINE

DMF 275642013

JANSSEN PHARMACEUTICA NVInactiveGALANTAMINE HYDROBROMIDE

DMF 144251999

JANSSEN PHARMACEUTICA NVInactiveGALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)

DMF 153842001

WUHAN SHIJI PHARMACEUTICAL CO LTDInactiveGALANTAMINE HYDROBROMIDE

DMF 179672005

MACFARLAN SMITH LTDInactiveGALANTAMINE HYDROBROMIDE

DMF 180782005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGALANTAMINE HYDROBROMIDE USP

DMF 181142005

SA AJINOMOTO OMNICHEM NVInactiveGALANTAMINE HYDROBROMIDE

DMF 181522005

JIANGSU SUNNY HEALTH INDUSTRY CO LTDInactiveGALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE)

DMF 191342006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Sep 27, 2022	SUPPL -27	View Letter (PDF)
Aug 4, 2021	SUPPL -26	View Letter (PDF)
Mar 23, 2020	SUPPL -25	View Letter (PDF)
Feb 25, 2020	SUPPL -24	View Letter (PDF)
Feb 16, 2017	SUPPL -23	View Letter (PDF)
Dec 17, 2015	SUPPL -22	View Letter (PDF)
Feb 12, 2015	SUPPL -21	View Letter (PDF)
Jul 2, 2013	SUPPL -16	View Letter (PDF)
Mar 5, 2012	SUPPL -9	View Letter (PDF)
Mar 5, 2012	SUPPL -8	View Letter (PDF)
Mar 5, 2012	SUPPL -18	View Letter (PDF)
May 1, 2006	SUPPL -1	View Letter (PDF)
May 1, 2006	SUPPL -5	View Letter (PDF)
May 1, 2006	SUPPL -4	View Letter (PDF)
May 1, 2006	SUPPL -3	View Letter (PDF)
May 3, 2005	SUPPL -2	View Letter (PDF)
Dec 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 1, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 1, 2005

#003 — EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 1, 2005