RAZADYNE ER Drug Patent Profile

When do Razadyne Er patents expire, and what generic alternatives are available?

Razadyne Er is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in RAZADYNE ER 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Razadyne Er

A generic version of RAZADYNE ER was approved as galantamine hydrobromide by BARR on August 28^th, 2008.

Summary for RAZADYNE ER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	21
Patent Applications:	4,377
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RAZADYNE ER
DailyMed Link:	RAZADYNE ER at DailyMed

See drug prices for RAZADYNE ER

Recent Clinical Trials for RAZADYNE ER

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Vanderbilt University	Phase 1/Phase 2
Doris Duke Charitable Foundation	Phase 1/Phase 2

See all RAZADYNE ER clinical trials

Pharmacology for RAZADYNE ER

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RAZADYNE ER

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

Paragraph IV (Patent) Challenges for RAZADYNE ER

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

US Patents and Regulatory Information for RAZADYNE ER

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 ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005	AB	RX	Yes	Yes
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005	AB	RX	Yes	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005	AB	RX	Yes	No

Expired US Patents for RAZADYNE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005

International Patents for RAZADYNE ER

See the table below for patents covering RAZADYNE ER around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I262079
Germany	3856594
European Patent Office	0236684	GALANTHAMINE OR ANALOGUES THEREOF FOR TREATING ALZHEIMER'S DISEASE
China	1331596

Supplementary Protection Certificates for RAZADYNE ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236684	SPC/GB00/033	United Kingdom		PRODUCT NAME: GALANTHAMINE OR ACID ADDITION SALTS THEREOF; REGISTERED: SE 15561 20000301; SE 15562 20000301; SE 15563 20000301; SE 15565 20000301; UK PL08557/0039 20000914; UK PL08557/0040 20000914; UK PL08557/0041 20000914; UK PL08557/0042 20000914
0236684	C300140	Netherlands		PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
0236684	2001C/007	Belgium		PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684	C00236684/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH