DrugPatentWatch Database Preview
BUPHENYL Drug Profile
Email this page to a colleague
» See Plans and PricingWhen do Buphenyl patents expire, and when can generic versions of Buphenyl launch?
Buphenyl is a drug marketed by Horizon Therap and is included in two NDAs.
The generic ingredient in BUPHENYL is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
US ANDA Litigation and Generic Entry Outlook for Buphenyl
A generic version of BUPHENYL was approved as sodium phenylbutyrate by ALVOGEN on November 18th, 2011.
Summary for BUPHENYL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 8 |
| Patent Applications: | 868 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BUPHENYL |
| DailyMed Link: | BUPHENYL at DailyMed |
Recent Clinical Trials for BUPHENYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 1/Phase 2 |
| Children's Hospital of Philadelphia | Phase 1/Phase 2 |
| University of Alabama at Birmingham | Phase 1/Phase 2 |
Pharmacology for BUPHENYL
| Drug Class | Nitrogen Binding Agent |
| Mechanism of Action | Ammonium Ion Binding Activity |
Synonyms for BUPHENYL
| 1716-12-7 |
| 4-PB |
| 4-Phenylbutyrate, Na |
| 4-phenylbutyric acid sodium |
| 4-Phenylbutyric Acid Sodium Salt |
| 4-phenylbutyric acid, sodium salt |
| 4PBA |
| A4107 |
| AB0013057 |
| AK-93011 |
| AKOS006344763 |
| AKOS015967141 |
| Ammonaps |
| Ammonapse |
| AMX-0035 COMPONENT SODIUM PHENYLBUTYRATE |
| AMX0035 COMPONENT SODIUM PHENYLBUTYRATE |
| AS-13914 |
| Benzenebutanoic acid, sodium salt |
| BG0653 |
| Buphenyl (TN) |
| C10H11NaO2 |
| C10H12O2.Na |
| CAS-1716-12-7 |
| CCG-213730 |
| CHEBI:75316 |
| CHEMBL1746 |
| CMK-304 |
| CS-1397 |
| CS0031 |
| CTK4F8662 |
| D05868 |
| DSSTox_CID_20948 |
| DSSTox_GSID_40948 |
| DSSTox_RID_79606 |
| DTXSID7040948 |
| EL-532 |
| FT-0619402 |
| H454 |
| HMS2089B22 |
| HMS3269N07 |
| HMS3413B10 |
| HMS3652K18 |
| HMS3677B10 |
| HY-15654 |
| J-010746 |
| J-524277 |
| KS-00000H29 |
| LS-173641 |
| Lunaphen |
| M-2491 |
| NaPb |
| NCGC00018113-03 |
| NCGC00018113-07 |
| NCGC00167830-01 |
| NSC 657802 |
| NSC-657802 |
| NT6K61736T |
| Phenylbutyric acid sodium salt |
| Q7553358 |
| s4125 |
| SCHEMBL125792 |
| sodium 4-phenylbutanoate |
| Sodium 4-phenylbutyrate |
| Sodium 4-Phenylbutyrate (Buphenyl) |
| Sodium 4-phenylbutyrate;TriButyrate |
| Sodium phenyl butirate |
| SODIUM PHENYLBUTYRATE |
| Sodium phenylbutyrate (JAN/USAN) |
| Sodium phenylbutyrate [USAN:BAN] |
| Sodium phenylbutyrate [USAN] |
| Sodium phenylbutyrate, >=98% (HPLC) |
| Sodium phenylbutyrate, European Pharmacopoeia (EP) Reference Standard |
| Sodium phenylbutyrate, United States Pharmacopeia (USP) Reference Standard |
| sodium-4-phenylbutyrate |
| sodium-phenylbutyrate |
| sodium;4-phenylbutanoate |
| SW219199-1 |
| Tox21_110826 |
| Tox21_110826_1 |
| TriButyrate |
| UNII-NT6K61736T |
| VP-101 |
| VPZRWNZGLKXFOE-UHFFFAOYSA-M |
US Patents and Regulatory Information for BUPHENYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Therap | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Horizon Therap | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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 BUPHENYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon Therap | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | Start Trial | Start Trial |
| Horizon Therap | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BUPHENYL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0177499 | Start Trial |
| World Intellectual Property Organization (WIPO) | 8504805 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BUPHENYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203431 | 2015/009 | Ireland | Start Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| 2932970 | 18C1043 | France | Start Trial | PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518 |
| 0145340 | 99C0005 | Belgium | Start Trial | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
| 0579826 | 02C0041 | France | Start Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 1259550 | 08C0052 | France | Start Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 2203431 | CR 2015 00014 | Denmark | Start Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
