BUPHENYL Drug Patent Profile

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 22^nd, 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
Drug Prices:	Drug price information for BUPHENYL
What excipients (inactive ingredients) are in BUPHENYL?	BUPHENYL excipients list
DailyMed Link:	BUPHENYL at DailyMed

See drug prices for BUPHENYL

Recent Clinical Trials for BUPHENYL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Phase 1/Phase 2
National Jewish Health	Phase 1/Phase 2
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 1/Phase 2

See all BUPHENYL clinical trials

Pharmacology for BUPHENYL

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

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
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	AB	RX	Yes	Yes

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
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996

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

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
European Patent Office	0177499

Supplementary Protection Certificates for BUPHENYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1856135	CA 2020 00018	Denmark		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
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1948158	1690020-1	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123