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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Summary for RAZADYNE ER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 21 |
| Patent Applications: | 4,602 |
| 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 |
| Doris Duke Charitable Foundation | Phase 1/Phase 2 |
| Vanderbilt University Medical Center | Phase 1/Phase 2 |
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 | 021615-003 | 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 | 021615-002 | 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 |
|---|---|---|---|
| Germany | 69912311 | ⤷ Sign Up | |
| Austria | 76294 | ⤷ Sign Up | |
| Luxembourg | 90710 | ⤷ Sign Up | |
| Norway | 327988 | ⤷ Sign Up | |
| South Korea | 100195399 | ⤷ 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 | C00236684/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| 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 | 2001C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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