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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. Fifteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
US ANDA 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 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 18 |
| Patent Applications: | 4,097 |
| 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 |
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 | 021615-001 | Apr 1, 2005 | Start Trial | Start Trial |
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RAZADYNE ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2755403 | Start Trial |
| South Korea | 100195399 | Start Trial |
| Croatia | P20010463 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RAZADYNE ER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 |
