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Last Updated: May 28, 2022

RAZADYNE ER Drug Patent 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

See drug prices for RAZADYNE ER

Recent Clinical Trials for RAZADYNE ER

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

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

See all RAZADYNE ER clinical trials

Pharmacology for RAZADYNE ER
Anatomical Therapeutic Chemical (ATC) Classes for RAZADYNE ER
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021615-002 Apr 1, 2005 See Plans and Pricing See Plans and Pricing
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 See Plans and Pricing See Plans and Pricing
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 See Plans and Pricing See Plans and Pricing
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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 See Plans and Pricing
Germany 3856594 See Plans and Pricing
European Patent Office 0236684 GALANTHAMINE OR ANALOGUES THEREOF FOR TREATING ALZHEIMER'S DISEASE See Plans and Pricing
China 1331596 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAZADYNE ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0236684 SPC/GB00/033 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684 C00236684/01 Switzerland See Plans and Pricing FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.