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BUPHENYL Drug Profile
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When do Buphenyl patents expire, and what generic alternatives are available?
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 launched as sodium phenylbutyrate by ALVOGEN on December 14th, 2019.
Summary for BUPHENYL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 67 |
| 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 |
| 1821-12-1 (Parent) |
| 4-PB |
| 4-Phenylbutyrate, Na |
| 4-phenylbutyric acid sodium |
| 4-Phenylbutyric Acid Sodium Salt |
| 4-phenylbutyric acid, sodium salt |
| 4PBA |
| A4107 |
| AB0013057 |
| AC1L1JY9 |
| AC1Q1V7N |
| AC1Q1V7P |
| AK-93011 |
| AKOS006344763 |
| AKOS015967141 |
| Ammonaps |
| Ammonapse |
| AN-49757 |
| 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 |
| HMS3652K18 |
| HY-15654 |
| I01-7248 |
| IN1087 |
| J-010746 |
| J-524277 |
| KS-00000H29 |
| LS-173641 |
| Lunaphen |
| M-2491 |
| MolPort-003-986-518 |
| NaPb |
| natrium-4-phenylbutanoat |
| NCGC00018113-03 |
| NCGC00018113-07 |
| NCGC00167830-01 |
| NSC 657802 |
| NT6K61736T |
| phenyl n-butyrate sodium salt |
| Phenylbutyric acid sodium salt |
| RL02207 |
| s4125 |
| SCHEMBL125792 |
| sodium 4-phenylbutanoate |
| Sodium 4-phenylbutyrate |
| Sodium 4-Phenylbutyrate (Buphenyl) |
| 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;4-phenylbutanoate |
| SW219199-1 |
| TL8001350 |
| 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 |
