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:	1,712
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
National Jewish Health	Phase 1/Phase 2
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 1/Phase 2
University of Alabama at Birmingham	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	4,457,942
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	4,457,942

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
European Patent Office	0177499
World Intellectual Property Organization (WIPO)	8504805

Supplementary Protection Certificates for BUPHENYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518

BUPHENYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BUPHENYL (Sodium Phenylbutyrate)

Introduction to BUPHENYL

BUPHENYL, also known as sodium phenylbutyrate, is a crucial medication used primarily to treat urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). These conditions are rare genetic disorders that affect the body's ability to break down ammonia, a toxic substance that can accumulate and cause severe health issues.

Market Size and Growth

The global sodium phenylbutyrate market, which includes BUPHENYL, is projected to experience significant growth. By 2030, the market is expected to reach $3.02 billion, up from $1.92 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the sodium phenylbutyrate market:

• Increasing Incidence of UCDs and MSUD: The estimated incidence of UCDs is 1 in 8,500 births, according to the Centers for Disease Control and Prevention (CDC). This increasing prevalence is a major driver of market growth[1].
• Rising Awareness: Growing awareness about the benefits of sodium phenylbutyrate for treating UCDs and MSUD is also contributing to the market's expansion[1].
• Government Support and Newborn Screening Programs: Government initiatives and newborn screening programs are helping to identify and treat these disorders early, further boosting the market[1].

Regional Insights

The market for sodium phenylbutyrate is geographically diverse, with different regions contributing to its growth:

• North America: This region is expected to dominate the global market due to the presence of major market players and advanced healthcare facilities. The growing patient population and newborn screening programs in North America are significant contributors to regional market growth[1][4].
• Europe: Europe is anticipated to be the second-largest market, driven by rising healthcare expenditure[1].
• Asia Pacific: The Asia Pacific region is expected to grow at a high rate due to improving healthcare infrastructure, rising medical tourism, and increasing healthcare spending[1].

Product Form and Distribution

The market for sodium phenylbutyrate is segmented based on product form and distribution channels:

• Product Form: The oral segment, which includes tablets and powder formulations, currently dominates the market. However, the oral powder formulation is expected to witness higher demand in the coming years[1][4].
• Distribution Channels: Hospital pharmacies account for a notable share of the market, followed by retail pharmacies. The online segment is also expanding significantly due to increasing internet penetration and government support[4].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

• Stringent Regulatory Approvals: The process of obtaining regulatory approvals is stringent and can hamper market growth[1].
• High Research and Development Costs: The costs associated with drug development are high, which can be a barrier for some market players[1].
• Side Effects: Common side effects of sodium phenylbutyrate, such as missed menstrual periods, loss of appetite, headache, nausea, and lower back pain, may also impact market growth[4].

Key Players and Competitive Landscape

The market for sodium phenylbutyrate is competitive, with several key players:

• Horizon Therapeutics plc: Known for its significant presence in the rare disease market, including the production of sodium phenylbutyrate[1].
• Ucyclyd Pharma, Inc.: This company offers BUPHENYL (sodium phenylbutyrate) and other related therapies[3].
• Other Players: Companies like Ammonett Pharma LLC, Medison Pharma Ltd., and Swedish Orphan Biovitrum AB (Sobi) are also active in this market[1].

Patient Assistance Programs

To support patients, programs like Amgen By Your Side offer assistance for those prescribed BUPHENYL. These programs help with enrollment, financial support, and other resources to ensure patients have access to the medication they need[5].

Financial Performance and Projections

The financial performance of companies involved in the sodium phenylbutyrate market is robust, with significant revenue growth expected:

• Revenue Growth: The market is projected to grow from $1.92 billion in 2023 to $3.02 billion by 2030, indicating a strong financial trajectory[1].
• Investments in R&D: Companies are investing heavily in research and development to enhance formulations and gain a competitive edge, particularly in the Asia Pacific region[1].

Recent Developments and Trends

The market is witnessing several recent developments that are shaping its future:

• New Product Launches: Key players are launching new products and formulations to improve treatment outcomes and patient compliance[1].
• Acquisitions and Partnerships: Strategic acquisitions and partnerships, such as Amgen's acquisition of Horizon Therapeutics, are also driving market growth and innovation[2].

Key Takeaways

• The global sodium phenylbutyrate market is expected to grow significantly, driven by increasing incidence of UCDs and MSUD.
• North America dominates the market, with Europe and Asia Pacific also showing promising growth.
• The oral segment, particularly the powder formulation, is expected to see higher demand.
• Key players are investing in R&D and strategic partnerships to enhance market presence.
• Patient assistance programs are crucial for ensuring access to this essential medication.

FAQs

What is BUPHENYL used for?

BUPHENYL, or sodium phenylbutyrate, is used primarily to treat urea cycle disorders (UCDs) and maple syrup urine disease (MSUD), which are rare genetic disorders affecting the body's ability to break down ammonia.

What is the projected market size for sodium phenylbutyrate by 2030?

The global sodium phenylbutyrate market is projected to reach $3.02 billion by 2030, growing at a CAGR of 6.7% from 2023[1].

Which region dominates the sodium phenylbutyrate market?

North America dominates the global sodium phenylbutyrate market due to the presence of major market players and advanced healthcare facilities[1][4].

What are the common side effects of sodium phenylbutyrate?

Common side effects include missed menstrual periods, loss of appetite, headache, nausea, and lower back pain[4].

Are there patient assistance programs available for BUPHENYL?

Yes, programs like Amgen By Your Side offer assistance to patients prescribed BUPHENYL, including enrollment support and financial aid[5].

Cited Sources:

1. Coherent Market Insights - Sodium Phenylbutyrate Market Size, Trends and Forecast to 2030
2. Stock Titan - AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
3. PR Newswire - The changing dynamics of the Argininosuccinic aciduria market
4. BioSpace - Sodium Phenylbutyrate Drugs Market: Oral Segment Witness Highest Growth
5. Amgen By Your Side - Patient Assistance for BUPHENYL® (sodium phenylbutyrate) | HCP