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Last Updated: August 6, 2020

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RAZADYNE Drug Profile

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Which patents cover Razadyne, and what generic alternatives are available?

Razadyne is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in RAZADYNE 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.

Drug patent expirations by year for RAZADYNE
Drug Prices for RAZADYNE

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Recent Clinical Trials for RAZADYNE

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SponsorPhase
Vanderbilt University Medical CenterPhase 1
Doris Duke Charitable FoundationPhase 1/Phase 2
Vanderbilt UniversityPhase 1/Phase 2

See all RAZADYNE clinical trials

Pharmacology for RAZADYNE
Paragraph IV (Patent) Challenges for RAZADYNE
Tradename Dosage Ingredient NDA Submissiondate
RAZADYNE TABLET;ORAL galantamine hydrobromide 021169 2005-02-28

US Patents and Regulatory Information for RAZADYNE

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 SOLUTION;ORAL 021224-001 Jun 22, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-003 Feb 28, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 AB RX Yes 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 RAZADYNE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide SOLUTION;ORAL 021224-001 Jun 22, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-001 Feb 28, 2001   Start Trial   Start Trial
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001   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

Supplementary Protection Certificates for RAZADYNE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0236684 SPC/GB00/033 United Kingdom   Start Trial 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 2001C/007 Belgium   Start Trial PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684 C00236684/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0236684 C300140 Netherlands   Start Trial 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 3/2001 Austria   Start Trial PRODUCT NAME: GALANTAMIN ODER SAEUREADDITIONSSALZE DAVON; NAT. REGISTRATION NO/DATE: 1-23748, 1-23749, 1-23750, 1-23751 20000822; FIRST REGISTRATION: SE 15561, 15562, 15563,15565 20000301
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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