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Last Updated: June 24, 2024

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. Thirteen 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 28th, 2008.

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

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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

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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ⤷  Sign Up ⤷  Sign Up
>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
Croatia P20010463 SMJESA S KONTROLIRANIM OTPUŠTANJEM KOJA SADRŽI GALANTAMIN (CONTROLLED RELEASE GALANTAMINE COMPOSITION) ⤷  Sign Up
European Patent Office 0236684 GALANTHAMINE OR ANALOGUES THEREOF FOR TREATING ALZHEIMER'S DISEASE ⤷  Sign Up
Austria 252386 ⤷  Sign Up
Estonia 200100319 ⤷  Sign Up
African Regional IP Organization (ARIPO) 1414 Controlled release galantamine composition. ⤷  Sign Up
Greece 3005447 ⤷  Sign Up
>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 ⤷  Sign Up 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 3/2001 Austria ⤷  Sign Up 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 2001C/007 Belgium ⤷  Sign Up PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684 C300140 Netherlands ⤷  Sign Up 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 C00236684/01 Switzerland ⤷  Sign Up FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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