Sodium phenylbutyrate - Generic Drug Details
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What are the generic drug sources for sodium phenylbutyrate and what is the scope of freedom to operate?
Sodium phenylbutyrate
is the generic ingredient in five branded drugs marketed by Acer, Medunik, Horizon Therap Us, Par Pharm, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, and Amylyx, and is included in ten NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium phenylbutyrate has twenty-five patent family members in twenty countries.
There are four drug master file entries for sodium phenylbutyrate. Six suppliers are listed for this compound.
Summary for sodium phenylbutyrate
International Patents: | 25 |
US Patents: | 8 |
Tradenames: | 5 |
Applicants: | 8 |
NDAs: | 10 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 38 |
Patent Applications: | 2,756 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in sodium phenylbutyrate? | sodium phenylbutyrate excipients list |
DailyMed Link: | sodium phenylbutyrate at DailyMed |
Recent Clinical Trials for sodium phenylbutyrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Maastricht University | Phase 4 |
Liminal BioSciences Ltd. | Phase 1 |
University of Nottingham | N/A |
Pharmacology for sodium phenylbutyrate
Drug Class | Nitrogen Binding Agent |
Mechanism of Action | Ammonium Ion Binding Activity |
US Patents and Regulatory Information for sodium phenylbutyrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sigmapharm Labs Llc | SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | POWDER;ORAL | 202819-001 | Mar 22, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-006 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-005 | Dec 22, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acer | OLPRUVA | sodium phenylbutyrate | FOR SUSPENSION;ORAL | 214860-002 | Dec 22, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | 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 sodium phenylbutyrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Horizon Therap Us | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Horizon Therap Us | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for sodium phenylbutyrate
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Eurocept International B. V. | Pheburane | sodium phenylbutyrate | EMEA/H/C/002500 Treatment of chronic management of urea-cycle disorders. |
Authorised | no | no | no | 2013-07-30 | |
Immedica Pharma AB | Ammonaps | sodium phenylbutyrate | EMEA/H/C/000219 Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy. |
Authorised | no | no | no | 1999-12-07 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sodium phenylbutyrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 3429559 | ⤷ Try a Trial | |
Japan | 2019509345 | フェニル酪酸ナトリウムを含む口当たりの良い組成物及びその使用 | ⤷ Try a Trial |
Hungary | E059630 | ⤷ Try a Trial | |
Canada | 3017573 | COMPOSITIONS AU GOUT AGREABLE COMPRENANT DU PHENYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF) | ⤷ Try a Trial |
Saudi Arabia | 518400020 | تركيبات مستساغة تتضمن فينيل بيوتيرات الصوديوم واستخداماتها (Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium phenylbutyrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1874117 | SPC/GB14/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
2203431 | 1590018-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
0480717 | SPC/GB98/025 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115 |
2203431 | 15C0013 | France | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119 |
1856135 | CR 2020 00018 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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