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Last Updated: July 2, 2020

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RAZADYNE ER Drug Profile


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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.

Drug patent expirations by year for RAZADYNE ER
Drug Prices for RAZADYNE ER

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Recent Clinical Trials for RAZADYNE ER

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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 ER clinical trials

Pharmacology for RAZADYNE ER
Paragraph IV (Patent) Challenges for RAZADYNE ER
Tradename Dosage Ingredient NDA Submissiondate
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 2006-03-11
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 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   Start Trial   Start Trial   Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 AB RX Yes 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
>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 ER

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

Supplementary Protection Certificates for RAZADYNE ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Moodys
Harvard Business School
Boehringer Ingelheim
Merck

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