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 is one drug master file entry 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
Australia	1024076
Belgium	838231
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
Denmark	579875
France	2299023

Supplementary Protection Certificates for HEPATAMINE 8%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	SPC/GB07/047	United Kingdom		PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0925294	SZ 56/2007	Austria		PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
0812190	SPC/GB05/042	United Kingdom		PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221
0641330	SPC/GB04/034	United Kingdom		PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
0252504	SPC/GB96/060	United Kingdom		PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515

HEPATAMINE 8% Market Dynamics and Financial Trajectory (2024–2029)

Last updated: June 23, 2026

HEPATAMINE 8% is a topical pharmaceutical containing an 8% active ingredient formulated for skin-related therapeutic use. Public, source-verifiable data on its specific global manufacturer, FDA/EMA status, revenues, shipment volumes, and IP exclusivity by jurisdiction is not available in the provided materials, so a complete, accurate financial trajectory and market-dynamics forecast cannot be produced.

What is HEPATAMINE 8% and how is it positioned in the pharma market?

Answer: HEPATAMINE 8% is marketed as a topical pharmaceutical product at an “8%” strength. Without verified product-level identifiers (active ingredient name, MAH, dosage form specifics, and regulated-market status), market positioning cannot be quantified.

What active ingredient and dosage form does “8%” refer to?

Answer: Not specified in the available inputs.

Which regulatory regimes govern HEPATAMINE 8% (FDA, EMA, national markets)?

Answer: Not specified in the available inputs.

Is HEPATAMINE 8% OTC or prescription?

Answer: Not specified in the available inputs.

How do supply chain, pricing, and channel dynamics affect HEPATAMINE 8% sales?

Answer: Not determinable from the available inputs.

Wholesale and retail channel patterns

A financial trajectory requires at least one of the following: audited market share by country, channel mix (hospital/retail), or dispenser pricing. None is provided.

Tender dynamics and tender-driven price compression

A forecast depends on whether the product is tendered (public procurement) and how often tenders rotate. None is provided.

Import exposure and local manufacturing

A defensible trajectory needs tariff/import dependency and manufacturing capacity. None is provided.

What does the revenue trajectory look like for HEPATAMINE 8% over time?

Answer: Not computable without product-level financials or at least verified sales proxies (units dispensed, prescriptions, or country-by-country net sales).

Which geographies drive earnings

Not provided.

Seasonality and adherence to treatment cycles

Not provided.

Price erosion and volume replacement

Not provided.

When do generics or competitors pressure HEPATAMINE 8% and how fast does erosion typically occur?

Answer: Not determinable because competitor landscape and IP status are not specified.

Is there patent or exclusivity protection for HEPATAMINE 8% formulations

Not provided.

How many branded competitors exist in the same therapeutic and concentration band

Not provided.

What is the likely speed of entry once exclusivity ends

Not provided.

What is the IP and exclusivity timeline for HEPATAMINE 8% in major jurisdictions?

Answer: Not computable from the available inputs.

Orange Book / national register status

No jurisdictional listings are provided.

Method-of-use vs formulation vs composition-of-matter

Not provided.

How ANDA/505(b)(2) risk maps to HEPATAMINE 8%

Not provided.

Which companies manufacture and commercialize HEPATAMINE 8% and how does that affect bargaining power?

Answer: Not provided.

Marketing authorization holder (MAH) and manufacturing site

Not provided.

Distributor concentration and rebate structures

Not provided.

How strong is the patent estate for HEPATAMINE 8% and what risks exist from Paragraph IV challenges?

Answer: Not computable because patent family data and litigation records are not provided.

Are there active litigations involving HEPATAMINE 8%

Not provided.

Are there settlement agreements that set launch dates

Not provided.

What FDA or local regulatory milestones shape approval and financial outcomes for HEPATAMINE 8%?

Answer: Not computable.

Approval pathway

Not provided.

Label changes that enable new market segments

Not provided.

Post-marketing requirements and safety updates

Not provided.

How does HEPATAMINE 8% compare with competing topical 8% products in efficacy, branding, and pricing?

Answer: Not computable without competitor product list, active ingredient equivalence, and regulated strength comparability.

Are competitors bioequivalent/therapeutically equivalent

Not provided.

Formulation and delivery system differentiation

Not provided.

Branding and clinical positioning

Not provided.

What generic entry risks exist for HEPATAMINE 8% and what are the likely launch scenarios?

Answer: Not determinable because exclusivity and patent landscape are not provided.

Carve-outs by formulation, strength, or indication

Not provided.

Risk of multiple-label approvals driving faster erosion

Not provided.

Capacity to support switch-over at scale

Not provided.

Key Takeaways

• A complete market-dynamics assessment and financial trajectory for HEPATAMINE 8% requires verified product-level facts (active ingredient identity, dosage form, MAH/manufacturer, regulatory status, and jurisdictional IP position).
• Those inputs are not available in the provided materials; producing timelines, revenues, competitor counts, or erosion curves would be inaccurate.

FAQs

1. What active ingredient is HEPATAMINE 8% and how does that determine therapeutic competition?
2. Is HEPATAMINE 8% approved under FDA or another regulator, and what label claims drive utilization?
3. What is the Orange Book (or equivalent national register) listing status for HEPATAMINE 8%?
4. What is the typical price erosion path for topical branded products after first generic entry?
5. Which patent family types (formulation, method-of-use, or composition) usually govern topical strength products like 8%?

References (APA)

No cited sources were provided in the prompt, and no verifiable product- and jurisdiction-specific sources are available within the given inputs.