RAZADYNE Drug Patent Profile
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When do Razadyne patents expire, 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. Twelve 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.
Summary for RAZADYNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 21 |
| Patent Applications: | 4,168 |
| Formulation / Manufacturing: | see details |
| 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 |
| Vanderbilt University | Phase 1/Phase 2 |
| Doris Duke Charitable Foundation | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for RAZADYNE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-003 | Feb 28, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-001 | Feb 28, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-001 | Feb 28, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-001 | Feb 28, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-002 | Feb 28, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | RAZADYNE | galantamine hydrobromide | SOLUTION;ORAL | 021224-001 | Jun 22, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Germany | 3779149 | ⤷ Try a Trial | |
| Spain | 2235234 | ⤷ Try a Trial | |
| Argentina | 070670 | TABLETA DE HIDROBROMURO DE GALANTAMINA DE DISOLUCION RAPIDA Y PROCESO PARA PREPARARLA | ⤷ Try a Trial |
| Hungary | 226132 | FAST-DISSOLVING GALANTHAMINE HYDROBROMIDE TABLET | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RAZADYNE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0236684 | 3/2001 | Austria | ⤷ Try a Trial | 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 | ⤷ Try a Trial | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| 0236684 | 2001C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301 |
| 0236684 | C300140 | Netherlands | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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