RAZADYNE Drug Patent Profile
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Which patents cover Razadyne, and what generic alternatives are available?
Razadyne is a drug marketed by Janssen Pharms and is included in three NDAs.
The generic ingredient in RAZADYNE 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
A generic version of RAZADYNE was approved as galantamine hydrobromide by BARR on August 28th, 2008.
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Summary for RAZADYNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 21 |
| Patent Applications: | 4,904 |
| Drug Prices: | Drug price information for RAZADYNE |
| What excipients (inactive ingredients) are in RAZADYNE? | RAZADYNE excipients list |
| DailyMed Link: | RAZADYNE at DailyMed |
Recent Clinical Trials for RAZADYNE
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
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RAZADYNE | Tablets | galantamine hydrobromide | 4 mg, 8 mg and 12 mg | 021169 | 14 | 2005-02-28 |
US Patents and Regulatory Information for RAZADYNE
| 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 | galantamine hydrobromide | SOLUTION;ORAL | 021224-001 | Jun 22, 2001 | DISCN | No | 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 | ||||
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-003 | Feb 28, 2001 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | SOLUTION;ORAL | 021224-001 | Jun 22, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-001 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-002 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RAZADYNE
See the table below for patents covering RAZADYNE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 506836 | ⤷ Sign Up | |
| Poland | 189329 | ⤷ Sign Up | |
| Germany | 3779149 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RAZADYNE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 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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