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
Patent Applications:	780
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

Constraining patent/regulatory exclusivity:

7,875,630

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
University of California, Irvine	Phase 4
Agency for Healthcare Research and Quality (AHRQ)	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.

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

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	8,207,191
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	RE39128
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	RE43390

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

International Patents for ALTABAX

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

Country	Patent Number	Title	Estimated Expiration
Japan	5719331
Peru	123299	DERIVADO DE PLEUROMUTILINA
Turkey	200001203

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	306	Finland
1028961	CA 2007 00052	Denmark

Market Dynamics and Financial Trajectory for Altabax

Introduction

Altabax, known by its generic name retapamulin, is a topical antibiotic ointment approved by the FDA in April 2007 for the treatment of impetigo caused by susceptible strains of Staphylococcus aureus or Streptococcus pyogenes. Here, we delve into the market dynamics and financial trajectory of Altabax.

Market Approval and Launch

Altabax was the first antibiotic in the pleuromutilin class, a new category of antibiotics. This distinction was significant due to its unique mechanism of action, which reduces the potential for cross-resistance with other antibiotics[1].

Physician Outlook and Patient Compliance

Physicians have viewed Altabax favorably due to its more convenient dosing schedule compared to other prescription topical antibiotics. It is dosed twice daily for a five-day period, which is simpler than the dosing regimen for competitors like Bactroban, which requires three times daily dosing for up to 12 days. This convenience enhances patient compliance and is seen as a major improvement[1].

Competitive Landscape

In the anti-infectants, non-systemic, topical market, Altabax competes with other established brands. As of 2007, the top 5 anti-infectants in this category showed varying sales growth, with Altabax benefiting from its new class status and favorable dosing schedule. The market competition was moderate, with Altabax positioning itself as a preferred option due to its unique characteristics[1].

Sales Performance

The sales data for Altabax, although not extensively detailed post-2007, indicates that it gained traction in the market. In the first half of 2007, Altabax was among the top-selling anti-infectants, with sales figures reflecting its growing acceptance. The overall market for topical antibiotics was substantial, with sales in the hundreds of millions of dollars annually[1].

Financial Trajectory

While specific financial data for Altabax post-2007 is limited, the overall trend in the pharmaceutical market suggests that successful drugs, especially those with unique mechanisms of action, tend to perform well financially. Here are some key points:

Initial Market Impact

• Altabax entered a market where other topical antibiotics were already established, but its unique dosing schedule and mechanism of action helped it gain market share.
• The initial sales figures indicated a positive start, with Altabax contributing to the overall revenue of its manufacturer, GlaxoSmithKline[1].

Long-term Potential

• The long-term financial trajectory of Altabax would depend on several factors, including market competition, resistance development, and patient compliance.
• Given its unique status as a pleuromutilin antibiotic, Altabax was expected to maintain a strong market presence, although the exact financial figures are not publicly available post-2007.

Market Growth and Trends

The broader market for topical antibiotics has seen fluctuations over the years, influenced by factors such as generic competition, resistance issues, and new drug approvals.

Generic Competition

• The impact of generic competition on branded drugs like Altabax can be significant. However, Altabax's unique mechanism of action and lack of cross-sensitivity with other antibiotics might mitigate some of this impact[3].

Resistance and Safety

• The potential for antibiotic resistance is a critical factor in the long-term success of any antibiotic. Altabax's unique mechanism reduces this risk, but ongoing monitoring is necessary[1].

Regional and Global Market

While Altabax's primary market data is focused on the US, the global market for topical antibiotics is diverse and influenced by regional healthcare policies and disease prevalence.

US Market

• In the US, Altabax has been positioned as a preferred treatment for impetigo due to its convenience and efficacy. The US market for topical antibiotics is substantial, and Altabax has carved out a niche within this segment[1].

Global Expansion

• The global market for antibiotics is vast, with varying levels of access and demand. Altabax's expansion into other regions would depend on regulatory approvals, market conditions, and local healthcare needs.

Key Takeaways

• Unique Mechanism: Altabax is the first in the pleuromutilin class of antibiotics, offering a unique mechanism of action that reduces cross-resistance.
• Convenient Dosing: Its twice-daily dosing for five days enhances patient compliance compared to other topical antibiotics.
• Market Position: Altabax has positioned itself favorably in the market due to its unique characteristics and convenience.
• Financial Potential: While specific post-2007 financial data is limited, Altabax's initial market performance and unique status suggest a strong financial trajectory.

FAQs

Q: What is Altabax used for? A: Altabax is used for the treatment of impetigo caused by susceptible strains of Staphylococcus aureus or Streptococcus pyogenes[1].

Q: How does Altabax differ from other topical antibiotics? A: Altabax is the first antibiotic in the pleuromutilin class, offering a unique mechanism of action and a more convenient dosing schedule compared to other topical antibiotics[1].

Q: What is the dosing regimen for Altabax? A: Altabax is dosed twice daily for a five-day period for patients nine months of age and older[1].

Q: Does Altabax have potential for antibiotic resistance? A: The potential for resistance is considered low due to its unique mechanism of action, but ongoing monitoring is necessary[1].

Q: How has Altabax performed in the market since its approval? A: Altabax has gained traction in the market due to its unique characteristics and convenience, although specific post-2007 financial data is limited[1].

Sources

1. MM+M: Altabax - MM+M - Medical Marketing and Media
2. Biofrontera: Investor Presentation - Biofrontera
3. PubMed: High Generic Drug Prices and Market Competition
4. GlobeNewswire: Airway Disease Treatment Market to Hit USD 3.54 Billion by 2032
5. ResearchGate: A Comprehensive Overview of the Antibiotics Approved in the Last Two Decades