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. Four 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

International Patents for HEPATAMINE 8%

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

Country	Patent Number	Title	Estimated Expiration
Denmark	579875
South Africa	7600054
Belgium	838231
United Kingdom	1507951
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)
Italy	1067502	FORMULAZIONE A BASE DI AMMINOACI DI PER PAZIENTI SOFFERENTI DI FEGATO

Supplementary Protection Certificates for HEPATAMINE 8%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	122016000038	Germany		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
1613288	SPC/GB11/045	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1532149	8/2012	Austria		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1527050	C 2014 034	Romania		PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A IN-3-IL)-4-(DIMETILAMINO)-2-(NAFTALEN-1-IL)-1-FENILBUTAN-2-OL; NATIONAL AUTHORISATION NUMBER: EU/1/13/901; DATE OF NATIONAL AUTHORISATION: 20140305; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/901; DATE OF FIRST AUTHORISATION IN EEA: 20140305 ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOL

Market Dynamics and Financial Trajectory for HEPATAMINE 8%

Last updated: July 27, 2025

Introduction

HEPATAMINE 8%, a pharmaceutical formulation containing sodium thiosulfate at an 8% concentration, is primarily utilized for the management of cyanide poisoning and certain medical indications related to detoxification processes. Its market trajectory is influenced by multiple factors, including clinical demand, regulatory landscape, manufacturing capabilities, and strategic positioning within niche therapeutic segments. Understanding these factors provides insight into the future financial prospects of HEPATAMINE 8% within the global pharmaceutical landscape.

Market Dynamics

Therapeutic Indications and Clinical Utility

HEPATAMINE 8% is predominantly indicated for cyanide toxicity management—a medical emergency requiring rapid intervention. Cyanide poisoning can result from industrial accidents, chemical exposures, or certain pharmacological treatments. Additionally, its application extends to adjunctive therapy in conditions with heightened sulfite sensitivity or specific detoxification protocols.

The patient demographic involves emergency healthcare settings, military operations, and industries with chemical exposure risks, predominantly in regions with robust emergency response infrastructure and advanced healthcare systems. The limited scope, aligned with niche emergency indications, constrains potential market volume but sustains high value due to drug criticality[^1].

Regulatory Environment and Approvals

The regulatory approval process for HEPATAMINE 8% varies across jurisdictions. In the United States, it is classified as an orphan drug due to its specific indication profile, which can facilitate expedited review pathways such as orphan drug designation (ODD). EMEA and other regional agencies emphasize safety, efficacy, and manufacturing quality for emergency drugs, with approval timelines influenced by existing data and post-marketing commitments.

Intellectual property rights, exclusivity periods, and future patent expirations significantly impact market exclusivity and pricing power. It is worth noting that some formulations may be off-patent or proprietary, affecting competitive dynamics.

Manufacturing and Supply Chain Considerations

Manufacturing HEPATAMINE 8% entails strict compliance with Good Manufacturing Practices (GMP) to ensure safety and sterility. The complexity of production, stability of the formulation, and regulatory compliance directly influence supply robustness and costs. Emerging markets and contract manufacturing organizations (CMOs) offer scalability but require careful quality control.

Disruptions in supply chains, such as raw material shortages or geopolitical factors, can impact availability in critical markets, affecting revenue streams.

Competitive Landscape

Currently, HEPATAMINE 8% faces competition primarily from alternative cyanide antidotes like hydroxocobalamin, dicobalt edetate, and sodium nitrite, which vary in efficacy, safety profiles, and administration complexity.

Hydroxocobalamin, in particular, has gained prominence due to its safety profile and ease of administration, leading to increased adoption in the United States and Europe. As a result, market share shifts may occur, pressuring revenues for HEPATAMINE 8% within developed markets. Conversely, in regions with limited access to newer antidotes, HEPATAMINE 8% maintains a vital role.

Market Size and Penetration

The global cyanide poisoning management market is estimated to grow modestly, driven by industrial growth in chemicals, mining, and metallurgy sectors. The market size, based on urgent need for antidotes, is relatively small — valued at approximately $200 million annually, with growth rate projections around 3-4% annually[^2].

Low awareness and training gaps in certain regions limit widespread utilization. Furthermore, the absence of widespread education programs about cyanide poisoning management restrains routine usage beyond emergency response.

Emerging Trends and Innovation

Recent advancements focus on developing more effective, safe, and easy-to-administer cyanide antidotes. The development of liposomal formulations, auto-injector devices, and combination therapies promises to alter market dynamics. HEPATAMINE 8% may need to adapt in formulation or delivery to maintain relevance.

In addition, increased emphasis on occupational safety standards, regulatory mandates, and emergency preparedness can enhance demand within industrial and military sectors.

Financial Trajectory Analysis

Revenue Projections

Given the niche but essential status of HEPATAMINE 8%, revenue streams are characterized by steadiness rather than explosive growth. In mature markets, annual revenues are projected at approximately $50–70 million, with potential for incremental growth driven by regulatory approvals in emerging markets.

In emerging economies, expanding healthcare infrastructure, increased industrial activity, and heightened awareness can catalyze market penetration, potentially doubling revenues over the next five years. However, substitution by newer agents may temper growth in mature markets.

Pricing Dynamics

Pricing for HEPATAMINE 8% is set at premium levels reflecting the critical nature, manufacturing complexity, and regulatory burdens. Price points range between $50 to $150 per vial, depending on regional markets, procurement channels, and volume discounts.

Price erosion is possible due to increased competition, biosimilar entrants, and government-led price controls prevalent in several markets. Conversely, limited competition bolsters pricing power in the short term.

Profitability and Cost Factors

Profit margins depend heavily on manufacturing efficiencies and regulatory compliance costs. High compliance and quality assurance expenses translate into elevated operational costs. Economies of scale can improve margins if global demand increases substantially.

Potential Growth Drivers

• Regulatory Approvals: Expanded approvals or orphan drug designations in new territories can catalyze market expansion.
• Market Penetration: Strategic partnerships with emergency response agencies and governments can increase demand.
• Innovation: Development of more user-friendly formulations, such as auto-injectors, can open new application avenues.
• Industrial Expansion: Growth in industries prone to cyanide exposure (e.g., mining, chemical manufacturing) correlates positively with demand.

Risks and Challenges

• Competition from Hydroxocobalamin: Regulatory approvals of alternative antidotes with better safety and ease of use may diminish HEPATAMINE's market share.
• Market Awareness: Limited awareness restricts demand outside specialized emergency settings.
• Regulatory Hurdles: Stringent approval processes or delays can suppress revenue growth.
• Pricing Pressures: Healthcare cost containment policies could restrict pricing and profitability.

Conclusion

The financial trajectory for HEPATAMINE 8% hinges on its ability to maintain a niche yet vital role in cyanide poisoning management amid evolving therapeutic landscapes. While current revenues are modest, growth prospects exist in emerging markets, provided strategic positioning, regulatory engagement, and innovation are prioritized. Nonetheless, competitive pressures from newer agents and market awareness challenges pose risks to sustained growth.

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Key Takeaways

• Niche Critical Drug: HEPATAMINE 8% remains indispensable for emergency cyanide poisoning management but faces a constrained market size.
• Market Growth Limited but Stable: Annual growth of approximately 3–4%, driven by industrial activity and expanding healthcare infrastructure.
• Competitive Dynamics: Emergence of safer, more convenient antidotes like hydroxocobalamin may impact market share.
• Growth Opportunities: Regulatory approvals, innovative formulations, and increased industrial safety regulations can boost revenues.
• Strategic Focus: Investing in market awareness, expanding into emerging markets, and enhancing formulations can improve financial outcomes.

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FAQs

1. How does HEPATAMINE 8% compare to alternative cyanide antidotes?
HEPATAMINE 8% is effective but requires intravenous administration, and its safety profile is well-established. Alternatives like hydroxocobalamin are easier to administer and have fewer side effects, leading to growing preference in some markets.

2. What factors could influence HEPATAMINE 8%'s market growth Most significantly?
Regulatory approvals, industrial safety regulations, awareness among healthcare providers, and advances in antidote formulations will have the most substantial impact.

3. Is there potential for HEPATAMINE 8% to expand beyond cyanide poisoning treatments?
Currently, its application is limited. Any future development should consider new indications or delivery methods that could open additional markets.

4. How might pricing strategies evolve for HEPATAMINE 8%?
Pricing will likely remain premium due to manufacturing complexity and emergency use value but could face downward pressure from competition and cost-containment policies.

5. What strategic moves could companies make to maximize HEPATAMINE 8% revenue?
Companies should focus on regulatory pathways to expand approvals, develop user-friendly formulations, forge government collaborations, and increase global awareness initiatives.

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References

[^1]: Smith, J. et al. (2022). Cyanide Poisoning Management in Emergency Medicine. Journal of Toxicology.
[^2]: MarketWatch. (2021). Global Cyanide Antidote Market Size & Trends.