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.
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.
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 |


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 |
Pharmacology for RAZADYNE ER
Drug Class | Cholinesterase Inhibitor |
Mechanism of Action | Cholinesterase Inhibitors |
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 |