OLPRUVA Drug Patent Profile

When do Olpruva patents expire, and when can generic versions of Olpruva launch?

Olpruva is a drug marketed by Acer and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-five patent family members in twenty countries.

The generic ingredient in OLPRUVA 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 Olpruva

A generic version of OLPRUVA was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22^nd, 2013.

Summary for OLPRUVA

International Patents:	25
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Patent Applications:	1,604
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OLPRUVA
What excipients (inactive ingredients) are in OLPRUVA?	OLPRUVA excipients list
DailyMed Link:	OLPRUVA at DailyMed

See drug prices for OLPRUVA

Anatomical Therapeutic Chemical (ATC) Classes for OLPRUVA

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for OLPRUVA

OLPRUVA is protected by three US patents.

Patents protecting OLPRUVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	Yes			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-002	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for OLPRUVA

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 OLPRUVA

See the table below for patents covering OLPRUVA around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112018068665	composições palatáveis incluindo o fenilbutirato de sódio e usos das mesmas
Spain	2922749
Poland	3429559
Australia	2016398029	Palatable compositions including sodium phenylbutyrate and uses thereof
Israel	296490	הרכבים טעימים הכוללים נתרן פנילביוטירייט ושימושים עבורם (Palatable compositions including sodium phenylbutyrate and uses thereof)
Japan	2022106927	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
Serbia	63383	SASTAVI PRIJATNOG UKUSA KOJI UKLJUČUJU NATRIJUM FENILBUTIRAT I NJIHOVA PRIMENA (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF)

Supplementary Protection Certificates for OLPRUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2203431	CR 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119