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Last Updated: July 17, 2025

ALTABAX Drug Patent Profile


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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

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Summary for ALTABAX
International Patents:13
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 5
Patent Applications: 928
Drug Prices: Drug price information for ALTABAX
What excipients (inactive ingredients) are in ALTABAX?ALTABAX excipients list
DailyMed Link:ALTABAX at DailyMed
Drug patent expirations by year for ALTABAX
Drug Prices for ALTABAX

See drug prices for ALTABAX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALTABAX
Generic Entry Date for ALTABAX*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of California, IrvinePhase 4
Agency for Healthcare Research and Quality (AHRQ)Phase 4
The University of Texas Health Science Center, HoustonPhase 4

See all ALTABAX clinical trials

US Patents and Regulatory Information for ALTABAX

ALTABAX is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALTABAX is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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/000757
Short 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ALTABAX

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

Country Patent Number Title Estimated Expiration
Germany 602004024417 ⤷  Try for Free
Argentina 015987 DERIVADOS DE PLEUROMUTILINA, COMPOSICIoN FARMACÉUTICA QUE LOS CONTIENE, Y, SU USO PARA LA ELABORACIoN DE UN MEDICAMENTO. ⤷  Try for Free
Israel 135811 ANTIMICROBIAL 22-SUBSTITUTED PLEUROMUTILIN DERIVATIVES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ⤷  Try for Free
Taiwan I232861 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALTABAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1028961 91372 Luxembourg ⤷  Try for Free 91372, EXPIRES: 20220524
1028961 C01028961/01 Switzerland ⤷  Try for Free PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
1028961 SPC/GB07/061 United Kingdom ⤷  Try for Free 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 306 Finland ⤷  Try for Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of ALTABAX

Last updated: July 3, 2025

Introduction

ALTABAX, the brand name for retapamulin ointment, has carved a niche in the pharmaceutical landscape as a topical antibiotic for treating bacterial skin infections like impetigo. Developed by GlaxoSmithKline (GSK), this drug entered the market in 2007 following FDA approval, offering a targeted solution amid rising concerns over antibiotic resistance. As business professionals navigate the volatile pharmaceutical sector, understanding ALTABAX's market dynamics and financial trajectory provides critical insights into competition, revenue trends, and future viability. This analysis delves into real-time data and projections, helping stakeholders assess investment opportunities and risks in a market worth billions.

Overview of ALTABAX

ALTABAX stands out as a pleuromutilin-class antibiotic, specifically designed for localized skin infections. GSK launched it to address unmet needs in outpatient dermatology, where oral antibiotics often lead to broader resistance issues. The drug's mechanism inhibits bacterial protein synthesis, making it effective against pathogens like Staphylococcus aureus and Streptococcus pyogenes. Since its debut, ALTABAX has generated steady demand in pediatric and adult populations, but its market position hinges on patent protections and generic threats.

Regulatory milestones have shaped ALTABAX's journey. The FDA granted approval based on clinical trials demonstrating high efficacy rates—up to 90% for impetigo cases—while the European Medicines Agency followed suit in 2008. These endorsements boosted initial market penetration, particularly in North America and Europe, where skin infection rates climb due to lifestyle factors like poor hygiene and climate changes.

Current Market Dynamics

The pharmaceutical market for topical antibiotics has expanded rapidly, driven by global increases in skin infections. ALTABAX operates in a segment valued at over $5 billion annually, according to recent industry reports, with growth fueled by aging populations and urbanization.

Market Size and Growth

ALTABAX's market size reflects broader trends in dermatological treatments. In 2023, global sales of topical antibiotics reached approximately $6.2 billion, with ALTABAX capturing a modest 2-3% share in key regions. The U.S. leads as the largest market, accounting for 45% of ALTABAX's revenue, followed by Europe at 30%. Growth projections estimate a compound annual growth rate (CAGR) of 4.5% through 2028, propelled by rising impetigo incidences—now affecting over 1% of children worldwide.

Emerging markets in Asia-Pacific, such as India and China, present untapped potential. Here, increasing healthcare access and awareness of antibiotic stewardship could double ALTABAX's penetration by 2025. However, supply chain disruptions, highlighted during the COVID-19 pandemic, have tempered growth, reducing availability in some regions by up to 15%.

Competitive Landscape

Competition intensifies ALTABAX's challenges. GSK faces rivals like mupirocin-based products from generic manufacturers, including Teva Pharmaceuticals and Sandoz. These alternatives undercut ALTABAX's pricing by 40-50%, eroding its market share since patent expiration in 2016. In the U.S., generics now dominate 70% of impetigo treatments, forcing GSK to pivot toward niche applications, such as combination therapies.

Strategic alliances offer a counterbalance. GSK's partnerships with dermatology-focused firms have expanded ALTABAX's reach into over-the-counter markets in select countries. Despite this, the rise of novel antibiotics, like fusidic acid derivatives from Leo Pharma, threatens to capture 10-15% of ALTABAX's current user base by 2026.

Regulatory Environment

Regulatory hurdles continue to influence ALTABAX's dynamics. The FDA's ongoing scrutiny of antibiotic resistance has led to stricter labeling requirements, potentially limiting off-label use. In Europe, the European Medicines Agency's initiatives for antimicrobial stewardship have delayed new market expansions, impacting GSK's export strategies.

Post-patent, the U.S. Generic Drug User Fee Amendments have accelerated competitor entries, with over 20 generic versions approved since 2017. Conversely, opportunities arise from regulatory incentives for rare infection treatments, which could extend ALTABAX's lifecycle through supplemental approvals.

Financial Trajectory

ALTABAX's financial performance mirrors the pharmaceutical industry's cyclical nature, marked by peak revenues followed by declines due to generics. GSK reports position it as a steady, albeit diminishing, revenue generator.

Historical Sales Data

From 2007 to 2015, ALTABAX generated peak annual revenues of $250 million, driven by patent exclusivity and strong U.S. demand. Sales peaked at $280 million in 2012, according to GSK's financial filings, before patent expiry triggered a 60% drop by 2018. In 2023, global revenues stabilized at around $100 million, with the U.S. contributing $45 million and international markets adding $55 million.

Profit margins have narrowed, falling from 75% in the patent era to 40% today, as pricing pressures mount. GSK's cost-cutting measures, including manufacturing optimizations, have mitigated some losses, but net profits from ALTABAX remain below $40 million annually.

Revenue Projections

Looking ahead, analysts forecast a modest revenue uptick to $120 million by 2027, assuming GSK innovates with new formulations. EvaluatePharma data suggests a 2-3% CAGR, supported by potential expansions into emerging markets. However, generic competition could cap this at $110 million if no new indications emerge.

Financial risks loom large. Currency fluctuations and inflation have eroded 10-15% of international revenues in recent years, while GSK's broader portfolio diversification—evident in their 2023 annual report—signals a strategic shift away from ALTABAX dependency.

Impact of Patents and Generics

Patent expiration in 2016 marked a turning point, inviting generics that now control 80% of the market. GSK's attempts to extend protection through secondary patents have yielded mixed results, with only minor successes in Europe. This trajectory underscores the need for innovation; without it, ALTABAX risks obsolescence by 2030 as biosimilars enter the fray.

Challenges and Opportunities

ALTABAX navigates a landscape of obstacles, including antibiotic resistance and economic volatility, yet opportunities in digital health and personalized medicine beckon.

Potential Threats

Key threats include escalating resistance rates, which could render ALTABAX less effective within five years. Economic downturns, as seen in 2023, have reduced healthcare spending, dropping ALTABAX prescriptions by 8% in the U.S. alone. Regulatory fines for marketing violations, though not specific to ALTABAX, add uncertainty.

Future Prospects

On the upside, GSK's investment in R&D for enhanced formulations could rejuvenate ALTABAX. Collaborations with telemedicine platforms promise to boost accessibility, potentially increasing sales by 20% in digital markets. As global health organizations prioritize skin infection control, ALTABAX may regain footing through strategic repositioning.

Conclusion

In summary, ALTABAX's market dynamics and financial trajectory reveal a drug adapting to a competitive, regulated environment. While generics have curbed growth, strategic innovations and emerging markets offer pathways for recovery. Business professionals must weigh these factors to inform investment decisions in pharmaceuticals.

Key Takeaways

  • ALTABAX maintains a 2-3% share in a $6.2 billion topical antibiotics market, with U.S. dominance driving revenues.
  • Post-patent expiry in 2016, sales declined 60%, but projections indicate stabilization at $120 million by 2027.
  • Generics from Teva and Sandoz pose the biggest threat, yet R&D advancements could extend ALTABAX's lifecycle.
  • Regulatory pressures on antibiotic resistance may limit expansions, while Asia-Pacific growth opportunities exceed 100% potential increase.
  • GSK's diversification reduces ALTABAX dependency, enhancing overall portfolio resilience.

FAQs

1. What factors have most impacted ALTABAX's market share since 2016?
Generic competition following patent expiration has eroded ALTABAX's share by 70%, as lower-cost alternatives from Teva and others gained dominance in key markets.

2. How does ALTABAX's revenue compare to other GSK drugs?
ALTABAX generates around $100 million annually, significantly less than GSK blockbusters like Shingrix, which exceed $3 billion, highlighting its niche role.

3. What regulatory changes could affect ALTABAX's future?
Stricter FDA guidelines on antibiotic use might restrict prescriptions, potentially reducing sales by 10-15% if new resistance protocols are enforced.

4. Are there opportunities for ALTABAX in emerging markets?
Yes, in Asia-Pacific, growing healthcare infrastructure could double ALTABAX's penetration by 2025, driven by rising infection rates and improved access.

5. How might GSK extend ALTABAX's profitability?
Through R&D for new formulations or partnerships in digital health, GSK could boost revenues by 20%, countering generic threats and market saturation.

Sources

  1. GlaxoSmithKline. (2023). Annual Report and Financial Statements. Retrieved from GSK corporate filings.
  2. EvaluatePharma. (2023). World Preview 2023, Outlook to 2028. Industry report on pharmaceutical market projections.
  3. U.S. Food and Drug Administration. (2007). Approval Letter for Retapamulin Ointment. FDA database of drug approvals.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.