BUPHENYL Drug Patent Profile
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When do Buphenyl patents expire, and when can generic versions of Buphenyl launch?
Buphenyl is a drug marketed by Horizon Therap Us 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. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Buphenyl
A generic version of BUPHENYL was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22nd, 2013.
Summary for BUPHENYL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,604 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BUPHENYL |
| What excipients (inactive ingredients) are in BUPHENYL? | BUPHENYL excipients list |
| DailyMed Link: | BUPHENYL at DailyMed |
Recent Clinical Trials for BUPHENYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital of Philadelphia | Phase 1/Phase 2 |
| Johns Hopkins University | Phase 1/Phase 2 |
| National Jewish Health | Phase 1/Phase 2 |
Pharmacology for BUPHENYL
| Drug Class | Nitrogen Binding Agent |
| Mechanism of Action | Ammonium Ion Binding Activity |
Anatomical Therapeutic Chemical (ATC) Classes for BUPHENYL
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 Us | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Horizon Therap Us | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | AB | 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 |
Expired US Patents for BUPHENYL
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon Therap Us | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BUPHENYL
| 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 BUPHENYL
See the table below for patents covering BUPHENYL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 8504805 | ⤷ Sign Up | |
| European Patent Office | 0177499 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BUPHENYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 1856135 | CA 2020 00018 | Denmark | ⤷ Sign Up | 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 |
| 2666774 | LUC00167 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217 |
| 2932970 | SPC/GB18/041 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
| 1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 1758590 | LUC00029 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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