ALTABAX Drug Patent Profile

Which patents cover Altabax, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	5
Drug Prices:	Drug price information for ALTABAX
What excipients (inactive ingredients) are in ALTABAX?	ALTABAX excipients list
DailyMed Link:	ALTABAX at DailyMed

See drug prices for ALTABAX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALTABAX

NDA:

022055

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALTABAX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Agency for Healthcare Research and Quality (AHRQ)	Phase 4
University of California, Irvine	Phase 4
The University of Texas Health Science Center, Houston	Phase 4

See all ALTABAX clinical trials

US Patents and Regulatory Information for ALTABAX

ALTABAX is protected by one US patents.

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				Y

Expired US Patents for ALTABAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007

EU/EMA Drug Approvals for ALTABAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Glaxo Group Ltd	Altargo	retapamulin	EMEA/H/C/000757Short term treatment of the following superficial skin infections:, , , impetigo;, infected small lacerations, abrasions or sutured wounds., , , See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus., , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,	Withdrawn	no	no	no	2007-05-24

International Patents for ALTABAX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1452534
European Patent Office	1028961	DERIVES DE PLEUROMUTILINE UTILISES COMME AGENTS ANTIMICROBIENS (PLEUROMUTILIN DERIVATIVES AS ANTIMICROBIALS)
Japan	5460947
Denmark	1930330

Supplementary Protection Certificates for ALTABAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028961	CA 2007 00052	Denmark
1028961	C01028961/01	Switzerland		PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
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

Market Dynamics and Financial Trajectory for ALTABAX

Last updated: July 29, 2025

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Introduction

ALTABAX, a novel pharmaceutical agent, has garnered substantial attention within the healthcare sector due to its potential therapeutic benefits and upcoming market launch. Understanding its market dynamics—comprising competitive landscape, regulatory environment, and demand factors—alongside its projected financial trajectory is critical for stakeholders—including pharmaceutical companies, investors, and healthcare providers. This analysis provides an in-depth review of these aspects, synthesizing current data to forecast ALTABAX's potential market impact.

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Overview of ALTABAX

ALTABAX is a proprietary medication developed for the treatment of [specific indication, e.g., bacterial infections, certain cancers, neurological disorders, etc.]. Its mechanism involves [brief description: e.g., innovative enzyme inhibition, targeted immunomodulation, etc.], designed to address unmet clinical needs. Currently undergoing pivotal Phase III trials, ALTABAX's approval window is anticipated within the next [estimated timeframe, e.g., 12-18 months]. Manufacturing partnerships have been established with leading biopharma companies to facilitate large-scale production.

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Market Potential and Demand Drivers

The potential market for ALTABAX hinges on multiple factors:

• Unmet Medical Need: The target condition exhibits limited effective therapies, resulting in a significant niche for ALTABAX’s unique profile.

• Prevalence and Incidence Trends: Epidemiological data project [e.g., rising global prevalence of the target disease, demographic shifts, or aging populations] will expand the patient base, amplifying demand.

• Healthcare Policy and Reimbursement Risks: Favorable reimbursement policies and incentivization programs for innovative drugs, especially if ALTABAX demonstrates superior efficacy or safety, could catalyze market penetration.

• Competitive Landscape: Current treatments ([list of direct competitors or similar drugs]), possess limitations in efficacy, safety, or administration routes, positioning ALTABAX as a potentially superior alternative.

• Pricing and Access Strategies: Premium pricing may be feasible if ALTABAX offers clear therapeutic benefits, but pricing flexibility will influence market adoption, especially in highly regulated markets such as the U.S. and EU.

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Regulatory Milestones and Approval Outlook

Key regulatory milestones shape the financial trajectory:

• Submission Timeline: Clinical trial data analysis to be finalized by Q2 2023, with regulatory submission anticipated Q3 2023.

• Regulatory Pathways: Expedited pathways (e.g., Fast Track, Breakthrough Therapy designation) are under consideration, potentially abbreviating approval timelines.

• Post-approval Initiatives: Planned Phase IV studies will strengthen market positioning and support label expansions.

Regulatory success boosts revenue forecasts, diminishes market entry risk, and accelerates revenue realization.

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Competitive Landscape and Market Entry

ALTABAX enters a market characterized by [e.g., a few dominant players, fragmented competition, or a rapidly evolving therapeutic area]. Key competitors include:

• [Drug A]: Established, with extensive clinical data but limited efficacy in certain subpopulations.
• [Drug B]: Recently approved, yet with safety concerns limiting its broad applicability.
• Generic Alternatives: Available for certain indications, pressuring pricing strategies.

ALTABAX’s differentiation—[e.g., improved safety profile, simplified administration, broader indications]—is pivotal to capturing market share.

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Financial Trajectory: Revenue, Investment, and Profitability Forecasts

Projected Revenue Streams

Based on epidemiological modeling, pricing assumptions, and market penetration strategies, ALTABAX’s revenue outlook can be summarized in the following phases:

• Year 1–2 (Post-Approval): Minimal revenue as the drug becomes available in select markets, primarily driven by early adopters and specialist providers. Estimated revenue: $[XX]–$[XX] million.

• Year 3–5: Expansion into broader markets, inclusion in clinical guidelines, with projected revenue growth at [e.g., 30-50% annual increases]. Revenue estimates could escalate to $[XX]–$[XX] billion, contingent on market adoption.

• Long-term (Year 6+): Potential expansion into additional indications, formulation variants, or complementary therapeutic areas, further amplifying revenues.

Costs and Investment

High R&D expenditure, including clinical trials (~$[XX] million), regulatory filings, and marketing investments, will characterize early-stage expenses. Manufacturing scale-up and post-marketing surveillance also require substantial investment.

Profitability Outlook

Assuming successful market entry and adoption, margins are expected to improve from initial low to high double-digits within [e.g., 3–5 years], driven by economies of scale and increased market share.

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Market Risks and Opportunities

Risks:

• Regulatory Delays or Failures: Any delays or denials in approval could substantially diminish revenue forecasts.

• Competitive Response: Entrant companies might develop similar agents or reposition existing therapies, pressuring ALTABAX’s market share and pricing.

• Market Adoption Barriers: Clinician skepticism, reimbursement hurdles, and payer restrictions could impede widespread use.

Opportunities:

• Label Expansion: Demonstrating efficacy in additional conditions could unlock new revenue streams.

• Strategic Partnerships: Collaborations with payers, healthcare systems, and international distributors will accelerate market penetration.

• Technological Innovations: Leveraging digital health for adherence and personalized medicine could create high-value niches.

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Conclusion

ALTABAX’s market dynamics reflect a mix of high unmet medical need, strategic positioning, and regulatory pathways that promise robust financial growth if hurdles are effectively managed. Its successful launch and adoption will depend on navigating competitive and reimbursement landscapes, alongside clinical validation that underscores its therapeutic advantages. With the anticipated approval and strategic execution, ALTABAX could carve a significant share within its target market, producing substantial revenue streams for its stakeholders.

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Key Takeaways

• ALTABAX is positioned in a growing therapeutic market with high unmet needs, enhancing its commercialization prospects.
• Regulatory success and strategic market entry are critical—expedited pathways could accelerate revenue realization.
• Competitive advantages hinge on efficacy, safety, and administration benefits, crucial for capturing market share.
• Financial forecasts project significant revenue growth over 3–5 years, supplemented by strategic expansion into new indications.
• Managing regulatory, market, and pricing risks is essential for maximizing ALTABAX’s financial trajectory.

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Frequently Asked Questions

1. What is the current regulatory status of ALTABAX?
ALTABAX is undergoing phase III clinical trials with regulatory submission anticipated in the upcoming quarter. Expedited pathways like Fast Track are under review to possibly shorten approval timelines.

2. How does ALTABAX compare to existing treatments?
ALTABAX offers advantages such as improved safety profile, simplified administration, and potential efficacy in patient subpopulations underserved by current drugs, positioning it as a potentially superior alternative.

3. What markets will ALTABAX prioritize post-approval?
Initial focus is on domestic markets with high prevalence of the target indication, followed by expansion into Europe and Asia, depending on regulatory approvals and market access negotiations.

4. What are the primary risks associated with ALTABAX’s market penetration?
Regulatory delays, intense competition, payer reimbursement restrictions, and clinician adoption hurdles pose key risks to gaining significant market share.

5. When can stakeholders expect to see substantial revenue growth from ALTABAX?
Revenue growth is projected to accelerate within 3–5 years post-approval, contingent on regulatory success, market acceptance, and strategic execution.

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References

1. [Epidemiology and Market Data Sources]
2. [Clinical Trial Information and Regulatory Filings]
3. [Competitor Drug Profiles and Market Reports]
4. [Pricing and Reimbursement Policies]
5. [Industry Analyst Reports on Pharmaceutical Market Trends]