CEREBYX Drug Patent Profile
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When do Cerebyx patents expire, and when can generic versions of Cerebyx launch?
Cerebyx is a drug marketed by Parke Davis and is included in one NDA.
The generic ingredient in CEREBYX is fosphenytoin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cerebyx
A generic version of CEREBYX was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6th, 2007.
Summary for CEREBYX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 1 |
| Patent Applications: | 2,656 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CEREBYX |
| What excipients (inactive ingredients) are in CEREBYX? | CEREBYX excipients list |
| DailyMed Link: | CEREBYX at DailyMed |
Recent Clinical Trials for CEREBYX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Phase 4 |
| UCB Pharma | Phase 4 |
Pharmacology for CEREBYX
Anatomical Therapeutic Chemical (ATC) Classes for CEREBYX
US Patents and Regulatory Information for CEREBYX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | AP | RX | Yes | Yes | ⤷ 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 CEREBYX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CEREBYX
See the table below for patents covering CEREBYX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | T61198 | ⤷ Try a Trial | |
| Singapore | 64881 | Stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester | ⤷ Try a Trial |
| Czechoslovakia | 9002566 | INJECTABLE AQUEOUS PHARMACEUTICAL FOR CONVULSIVE CONDITIONS' THERAPY AND TREATMENT | ⤷ Try a Trial |
| Norway | 914582 | ⤷ Try a Trial | |
| Canada | 2067122 | ⤷ Try a Trial | |
| Netherlands | 980045 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CEREBYX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0473687 | 3/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204 |
| 0473687 | C980045 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204 |
| 0473687 | SPC/GB98/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
| 0473687 | 99C0008 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204 |
| 0145340 | 99C0005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
| >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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