SODIUM PHENYLBUTYRATE Drug Patent Profile
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When do Sodium Phenylbutyrate patents expire, and when can generic versions of Sodium Phenylbutyrate launch?
Sodium Phenylbutyrate is a drug marketed by Par Pharm, Sigmapharm Labs Llc, Alvogen, and Glenmark Pharms Ltd. and is included in five NDAs.
The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Phenylbutyrate
A generic version of SODIUM PHENYLBUTYRATE was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22nd, 2013.
Summary for SODIUM PHENYLBUTYRATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 38 |
| Patent Applications: | 1,744 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for SODIUM PHENYLBUTYRATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm | SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | POWDER;ORAL | 203918-001 | Jun 15, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Glenmark Pharms Ltd | SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | TABLET;ORAL | 216462-001 | Nov 1, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| 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 | |||
| Alvogen | SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | TABLET;ORAL | 090910-001 | Nov 18, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Par Pharm | SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | TABLET;ORAL | 204395-001 | Apr 15, 2016 | AB | RX | No | 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 |
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 |
