PHEBURANE Drug Patent Profile
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Which patents cover Pheburane, and when can generic versions of Pheburane launch?
Pheburane is a drug marketed by Medunik and is included in one NDA.
The generic ingredient in PHEBURANE 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 Pheburane
A generic version of PHEBURANE was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22nd, 2013.
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Questions you can ask:
- What is the 5 year forecast for PHEBURANE?
- What are the global sales for PHEBURANE?
- What is Average Wholesale Price for PHEBURANE?
Summary for PHEBURANE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,604 |
| Drug Prices: | Drug price information for PHEBURANE |
| What excipients (inactive ingredients) are in PHEBURANE? | PHEBURANE excipients list |
| DailyMed Link: | PHEBURANE at DailyMed |
Recent Clinical Trials for PHEBURANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maastricht University | Phase 4 |
Pharmacology for PHEBURANE
| Drug Class | Nitrogen Binding Agent |
| Mechanism of Action | Ammonium Ion Binding Activity |
US Patents and Regulatory Information for PHEBURANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medunik | PHEBURANE | sodium phenylbutyrate | PELLETS;ORAL | 216513-001 | Jun 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 PHEBURANE
| 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 |
