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. 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 | ||||
>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 | 021169-003 | 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 |
Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-002 | Feb 28, 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 |
---|---|---|---|
Hungary | 226132 | FAST-DISSOLVING GALANTHAMINE HYDROBROMIDE TABLET | ⤷ Try a Trial |
Australia | 3174397 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9747304 | ⤷ 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 | SPC/GB00/033 | United Kingdom | ⤷ Try a 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 |
0236684 | C00236684/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |