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
Canada	1050890	FORMULE A BASE D'ACIDES AMINES POUR NOURRIR LES MALADES ATTEINTS DE MALADIES DU FOIE ET METHODE D'UTILISATION (AMINO ACID FORMULATIONS FOR PATIENTS WITH LIVER DISEASE AND METHOD OF USING SAME)
Germany	2556100
Japan	S5627493
Netherlands	7515199
New Zealand	179655	A MIXTURE OF ESSENTIAL AND NON-ESSENTIAL AMINO ACIDS FOR HUMANS

Supplementary Protection Certificates for HEPATAMINE 8%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	2016C/026	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2377536	92275	Luxembourg		PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
1686964	C 2015 008	Romania		PRODUCT NAME: PASIREOTIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIASAU ORICE HIDRAT AL ACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF NATIONAL AUTHORISATION: 20141119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/753/013, EU/1/12/753/014, EU/1/12/753/015, EU/1/12/753/016, EU/1/12/753/017; DATE OF FIRST AUTHORISATION IN EEA: 20141119
0820432	SPC/GB05/044	United Kingdom		PRODUCT NAME: HEXYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY HEXYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 19227 20040917; UK PL 18952/0003 20050714
1506193	SPC/GB14/044	United Kingdom		PRODUCT NAME: RIOCIGUAT, I.E. METHYL N-(4,6-DIAMINO-2-(1-(2-FLUOROBENZYL)-1H-PYRAZOLO (3,4-B)PYRIDIN-3-YL)-5-PYRIMIDINYL(METHYL)CARBAMATE,OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE THEREOF.; REGISTERED: UK EU/1/13/907 20140331
2187879	SPC/GB17/031	United Kingdom		PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK...

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