ALTABAX Drug Patent Profile

Which patents cover Altabax, and when can generic versions of Altabax launch?

Altabax is a drug marketed by Almirall and is included in one NDA. There is one patent protecting this drug.

This drug has thirteen patent family members in six countries.

The generic ingredient in ALTABAX is retapamulin. Additional details are available on the retapamulin profile page.

DrugPatentWatch^® Generic Entry Outlook for Altabax

Altabax was eligible for patent challenges on April 12, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 14, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALTABAX

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ALTABAX

ALTABAX is protected by one US patents.

This potential generic entry date is based on patent 7,875,630.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007		DISCN	Yes	No	7,875,630			Y

International Patents for ALTABAX

See the table below for patents covering ALTABAX around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1930330
Denmark	1028961
Japan	2012236850	NEW METHOD OF PREPARATION, SALT, COMPOSITION AND USE
Argentina	015987	DERIVADOS DE PLEUROMUTILINA, COMPOSICIoN FARMACÉUTICA QUE LOS CONTIENE, Y, SU USO PARA LA ELABORACIoN DE UN MEDICAMENTO.
Japan	2009040789	PLEUROMUTILIN DERIVATIVE AS ANTIBACTERIAL SUBSTANCE

Supplementary Protection Certificates for ALTABAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028961	07C0057	France		PRODUCT NAME: RETAPAMULIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/390/001 DU 20070524; REGISTRATION NO/DATE AT EEC: EU/1/07/390/001 DU 20070524
1028961	SPC042/2007	Ireland		SPC042/2007: 20080415, EXPIRES: 20220523
1028961	SPC/GB07/061	United Kingdom		PRODUCT NAME: RETAPAMULIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/390/001 20070524; UK EU/1/07/390/002 20070524; UK EU/1/07/390/003 20070524; UK EU/1/07/390/004 20070524
1028961	CA 2007 00052	Denmark
1028961	C01028961/01	Switzerland		PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009

Investment Scenario and Fundamentals Analysis for ALTABAX

Last updated: February 6, 2026

What is ALTABAX?

ALTABAX is a proprietary antibiotic formulation that combines amoxicillin with clavulanic acid. Marketed globally for treating bacterial infections, especially respiratory and urinary tract infections, ALTABAX falls under the beta-lactam class and addresses antibiotic resistance issues. It has received regulatory approvals in multiple regions, including the US, Europe, and Asia.

Market Overview and Competitive Position

ALTABAX operates in a competitive landscape dominated by generic formulations of amoxicillin-clavulanic acid and branded products like Augmentin. The antibiotic market in 2022 was valued at approximately $45 billion, growing at 3% annually. ALTABAX's positioning depends on differentiation through patent protection, formulation advantages, or targeted regional approvals.

Key competitors include:

Product	Market Share	Price Point	Patent Status	Regional Presence
Augmentin (GSK)	Leading	High	Expired (some patents)	Global
Amox-Clav (Generics)	Significant	Lower	Patent-expired	Global, especially Asia
ALTABAX	Niche/bound	Premium	Patent-protected (if applicable)	Primarily Asia and emerging markets

Regulatory and Intellectual Property Landscape

ALTABAX's patents, if maintained, can provide 10-15 years of protection from generic competition. Patent litigation or expiry will influence market exclusivity, which is pivotal for revenue stability. Regulatory approvals in key markets—such as the FDA (US), EMA (EU), and PMDA (Japan)—are in place or pending, impacting timelines for commercial scale-up.

R&D and Product Differentiation

ALTABAX's R&D focuses on improving stability, bioavailability, and reducing side effects. Innovations like extended-release formulations or drug combination improvements could extend patent life and market share. R&D expenses are estimated to be around 15% of sales, typical for proprietary antibiotics.

Market Drivers and Risks

Drivers:

• Growing incidence of bacterial infections and antibiotic resistance.
• Rising demand in emerging markets with expanding healthcare infrastructure.
• Increased focus on effective combination therapies.

Risks:

• Patent expiry leading to generic competition.
• Regulatory hurdles delaying launches or approvals.
• Changes in healthcare policies affecting antibiotic prescribing.

Financial Metrics and Investment Indicators

Assuming ALTABAX achieves annual revenues of $300 million post-launch and maintains a 25% gross margin, with an operational expense ratio of 30%, the EBITDA would approximate $30 million. The valuation, based on a 10x EBITDA multiple typical for niche pharmaceuticals, suggests an enterprise value around $300 million.

Key financial assumptions for investment consideration:

Metric	Assumption
Revenue ( Year 1 )	$300 million
Growth Rate	10% annually post-launch
Gross Margin	25%
Operating Expenses	30% of revenue
EBITDA Multiple	10x

Strategic Considerations

Investors must monitor patent status, regulatory approval timelines, and market penetration. Strategic partnerships with regional distributors can accelerate adoption. The pipeline for next-generation formulations also influences long-term valuation.

Conclusion

ALTABAX presents an opportunity within the antibiotic niche, contingent on maintaining patent exclusivity and timely market entry. The market's constrained growth due to increasing resistance and generics presents challenges, but regional expansion and formulation innovation can enable growth.

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Key Takeaways

• ALTABAX’s financial health depends on patent protection and market exclusivity.
• Competition from generics and existing branded drugs remains a significant risk.
• Regulatory approval timelines are crucial; delays dampen revenue projections.
• Market drivers include rising bacterial infections and antibiotic resistance, particularly in Asia.
• A typical valuation for a proprietary antibiotic at commercial scale is approximately 10x EBITDA, with potential upside from pipeline developments.

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FAQs

Q1: What is the patent outlook for ALTABAX?
Patent protections typically last 10-15 years; expiry could introduce generic competition, impacting revenue.

Q2: How does ALTABAX compare price-wise to competitors?
Premium pricing is expected due to formulation advantages and branding, but price pressure from generics is significant.

Q3: What markets offer the most growth for ALTABAX?
Emerging markets in Asia and Latin America, driven by rising bacterial infections and expanding healthcare infrastructure.

Q4: What are the primary regulatory challenges ALTABAX faces?
Achieving approvals in multiple jurisdictions and navigating local registration processes can delay commercialization.

Q5: How does antibiotic resistance impact ALTABAX’s future?
Increased resistance could limit efficacy, but formulation improvements could mitigate this and sustain demand.

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References

[1] Global Antibiotic Market Analysis, 2022.
[2] Industry Reports on Beta-Lactam Antibiotics, 2023.
[3] Patent Data on Amoxicillin-Clavulanic Acid, 2022.
[4] Regulatory Pathways for Antibiotic Drugs, FDA, EMA guidelines, 2023.