HEPATAMINE 8% Drug Patent Profile

When do Hepatamine 8% patents expire, and when can generic versions of Hepatamine 8% launch?

Hepatamine 8% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in HEPATAMINE 8% is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepatamine 8%

A generic version of HEPATAMINE 8% was approved as amino acids by B BRAUN on April 13^th, 2012.

Summary for HEPATAMINE 8%

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	HEPATAMINE 8% at DailyMed

US Patents and Regulatory Information for HEPATAMINE 8%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982		DISCN	No	No

Expired US Patents for HEPATAMINE 8%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982	3,950,529

International Patents for HEPATAMINE 8%

See the table below for patents covering HEPATAMINE 8% around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	1024076
Italy	1067502	FORMULAZIONE A BASE DI AMMINOACI DI PER PAZIENTI SOFFERENTI DI FEGATO
Japan	S51118839	AMINO ACID PHARMACY FOR LIVERISH PATIENT DOSAGE
Netherlands	7515199
Philippines	11557	AMINO ACID FORMULATIONS FOR PATIENTS WITH LIVER DISEASE AND METHOD OF USING SAME
South Africa	7600054
United Kingdom	1507951

Supplementary Protection Certificates for HEPATAMINE 8%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	2/2021	Austria		PRODUCT NAME: SACUBITRIL/VALSARTAN ALS SACUBITRIL-VALSARTAN-NATRIUMSALZ-KOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA3 ? X H2O, WOBEI X FUER 0 BIS 3 STEHT; REGISTRATION NO/DATE: EU/1/15/1058 (MITTEILUNG) 20151123
2377536	300612	Netherlands		PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
1506193	C 2014 026	Romania		PRODUCT NAME: RIOCIGUAT4,6-DIAMINO-2-[1-(-FLUORBENZIL)-1H-PIRAZOLO[3,4-B]PIRIDIN-3-IL]-5-PIRIMIDINIL 20140327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/907; DATE OF FIRST AUTHORISATION IN EEA: 20140327 (METIL)CARBAMAT DEMETIL; NATIONAL AUTHORISATION NUMBER: EU/1/13/907; DATE OF NATIONAL AUTHORISATION:
1666481	C 2017 029	Romania		PRODUCT NAME: TOFACITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA CITRAT 3-((3R,4R)-4-METIL-3-{METIL-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-AMINO]PERIDINIL)-3-OXO-PROPIONITRIL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF NATIONAL AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
2404919	CA 2016 00019	Denmark		PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124
2340828	PA2021502,C2340828	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3 - X H2O, KUR X YRA 0 - 3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
0694547	SPC/GB02/027	United Kingdom		PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425

Market Dynamics and Financial Trajectory for HepatAmine 8%

Overview of HepatAmine 8%

HepatAmine 8% (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids, specifically formulated to provide nutritional support and therapy for patients with liver disease who have hepatic encephalopathy. This drug is crucial in managing the nutritional needs of these patients without exacerbating their condition[2][5].

Market Size and Growth

The global hepatic encephalopathy market, within which HepatAmine 8% operates, is estimated to be valued at US$ 403.3 million in 2023. This market is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2023 to 2030, reaching a projected value of US$ 592.9 million by 2030[1].

Key Drivers of Market Growth

Several factors are driving the growth of the hepatic encephalopathy market, and by extension, the demand for HepatAmine 8%:

Increase in Product Launches

Key market players are increasingly launching new products and combination therapies, which is expected to drive market growth. For example, Bausch Health Companies Inc. announced positive results for a Phase II study on a combination therapy including rifaximin and lactulose for the treatment of overt hepatic encephalopathy (OHE)[1].

Rising Prevalence of Liver Diseases

The increasing prevalence of liver diseases such as jaundice, hepatitis, and cirrhosis is a significant driver. Cirrhosis, in particular, is a leading cause of mortality and morbidity globally, accounting for 2.2% of deaths and 1.5% of disability-adjusted life years worldwide in 2016[1].

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval of injectable HepatAmine (8% Amino Acid Injection) in August 2022, further boost the market. This approval highlights the growing recognition of the need for effective treatments for hepatic encephalopathy[1].

Market Segmentation

The hepatic encephalopathy market is segmented based on several criteria:

Route of Administration

The intravenous segment is expected to dominate the market over the forecast period, driven by the increasing approval and launch of intravenous products like HepatAmine 8%[1].

Distribution Channel

Hospital pharmacies are expected to dominate the market, driven by the increasing patient visits for liver diseases and the need for immediate and specialized care[1].

Geographic Region

North America is expected to hold the largest market share, with major players such as ASKA Pharmaceutical Co., Ltd., Cosmo Pharmaceuticals N.V, and Lupin Limited operating in this region. The European region is also significant due to the high incidence of cirrhosis and liver failure[1].

Financial Trajectory

The financial trajectory of HepatAmine 8% is closely tied to the overall growth of the hepatic encephalopathy market.

Revenue Projections

Given the market's projected CAGR of 5.6%, the revenue generated by HepatAmine 8% is expected to increase significantly over the forecast period. The drug's approval and inclusion in treatment protocols for hepatic encephalopathy will contribute to its financial growth.

Competitive Landscape

The market is competitive, with several key players. However, the approval of HepatAmine 8% and its specific formulation to address the nutritional needs of patients with liver disease position it as a significant player in the market. Companies like Bausch Health Companies Inc. and other major pharmaceutical firms are investing heavily in research and development, which will further drive the financial performance of HepatAmine 8%[1].

Clinical and Therapeutic Impact

HepatAmine 8% has a significant clinical impact on patients with hepatic encephalopathy:

Mechanism of Action

The drug helps in normalizing the abnormal plasma amino acid patterns seen in patients with liver disease, which is associated with an improvement in mental status and EEG patterns. This is achieved by providing a balanced mix of essential and non-essential amino acids[2][5].

Dosage and Administration

The recommended dosage is 80-120 grams of amino acids (12-18 grams of nitrogen) per day, typically administered over an 8-12 hour period. The drug can be administered through central venous or peripheral routes, depending on the patient's condition[2][5].

Challenges and Opportunities

Challenges

Despite the positive outlook, there are challenges such as fluid intake limits, glucose and nitrogen intolerance, and the need for careful monitoring of electrolytes and metabolic responses. These challenges require precise management to ensure the drug's efficacy and safety[2][5].

Opportunities

The increasing incidence of liver diseases and the lack of effective treatments in some regions present opportunities for market expansion. Additionally, ongoing research and development in combination therapies and new formulations can further enhance the market position of HepatAmine 8%[1].

Key Takeaways

• Market Growth: The global hepatic encephalopathy market is expected to grow at a CAGR of 5.6% from 2023 to 2030.
• Key Drivers: Increase in product launches, rising prevalence of liver diseases, and regulatory approvals are driving the market.
• Market Segmentation: Intravenous administration and hospital pharmacies are expected to dominate the market.
• Financial Trajectory: Revenue is projected to increase significantly due to the drug's approval and inclusion in treatment protocols.
• Clinical Impact: HepatAmine 8% normalizes plasma amino acid patterns, improving mental status and EEG patterns in patients with hepatic encephalopathy.

FAQs

Q: What is the current market size of the global hepatic encephalopathy market? A: The global hepatic encephalopathy market is estimated to be valued at US$ 403.3 million in 2023[1].

Q: What is the projected CAGR for the global hepatic encephalopathy market from 2023 to 2030? A: The market is expected to exhibit a CAGR of 5.6% during the forecast period[1].

Q: Which region is expected to dominate the global hepatic encephalopathy market? A: North America is expected to hold the largest market share, followed by Europe[1].

Q: What is the recommended dosage for HepatAmine 8%? A: The recommended dosage is 80-120 grams of amino acids (12-18 grams of nitrogen) per day, typically administered over an 8-12 hour period[2][5].

Q: How is HepatAmine 8% administered? A: The drug can be administered through central venous or peripheral routes, depending on the patient's condition[2][5].

Sources

1. Coherent Market Insights: Hepatic Encephalopathy Market Size and Forecast to 2030
2. FDA: HepatAmine® (8% Amino Acid Injection) - accessdata.fda.gov
3. Avalere: How May the IRA Shift Part D Market Dynamics?
4. Frontiers: Big peptide drugs in a small molecule world
5. Drugs.com: HepatAmine Dosage Guide