retapamulin - Profile

What are the generic sources for retapamulin and what is the scope of patent protection?

Retapamulin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Retapamulin has thirteen patent family members in six countries.

Summary for retapamulin

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

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

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.

US Patents and Regulatory Information for retapamulin

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 retapamulin

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 retapamulin

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aureus., , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,	Withdrawn	no	no	no	2007-05-24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 retapamulin

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2181995	Sels et forme crystalline de mutilin 14-(exo-8-methyl-8-azabicyclo[3.2.1]oct-3-yl-sufanyl)-acetate (Salts and crystalline form of mutilin 14-(exo-8-methyl-8-azabicyclo[3.2.1]oct-3-yl-sufanyl)-acetate)
Japan	5719331
World Intellectual Property Organization (WIPO)	2005023257

Supplementary Protection Certificates for retapamulin

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

Investment Scenario and Fundamentals Analysis for Retapamulin

Last updated: February 27, 2026

What is Retapamulin and Its Market Position?

Retapamulin is a topical antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2007. It belongs to the pleuromutilin class and is used primarily for treating impetigo and minor skin infections caused by susceptible bacteria such as Staphylococcus aureus and Streptococcus pyogenes. It is marketed under the brand name ALTABAX (Europe) and other regional labels.

Retapamulin's sales are limited by its niche application, with a primary focus on dermatological infections. The drug's market presence remains concentrated among dermatologists, pediatricians, and infectious disease specialists. It is listed for use in select countries, with no immediate generics or biosimilars competing directly on a large scale.

Regulatory and Patent Status

• FDA Approval: 2007 (U.S.)
• European Approval: 2007
• Patent Expiry: Original patents expired around 2017-2019, with secondary patents possibly protecting formulations or delivery methods into 2025.
• Market Exclusivity: Other jurisdictions may have longer exclusivity periods, but no recent patent extensions are publicly announced.

Market Fundamentals

Item	Data	Source
Global Topical Antibiotic Market	Estimated at USD 5.2 billion in 2022, projected to grow at 4.2% CAGR through 2027	MarketsandMarkets[1]
Retapamulin-specific Sales	Estimated around USD 20 million annually, primarily in Europe and select U.S. markets	Industry reports, IQVIA
Key Indications	Impetigo in pediatric and adult populations; other minor skin infections	FDA Drug Labeling
Competition	Mupirocin, retapamulin’s main competitors; other topical agents include fusidic acid and retapamulin's off-label peers	IMS Health

Revenue and Growth Outlook

Retapamulin's growth prospects depend on several factors:

• Market Penetration: Limited penetration due to competitive landscape and off-label use restrictions.
• Pipeline Development: No publicly disclosed pipeline development or reformulations underway.
• Regulatory Environment: Potential for expanded indications or regional approvals could influence sales.
• Pricing Dynamics: Premium pricing in certain markets, though constrained by generic competition.

The overall market for topical antibiotics is mature, with slow growth. Retapamulin's niche positioning suggests stable but modest revenue.

Investment Risks

• Patent Cliffs: Patent expiry reduces exclusivity, allowing generic entry.
• Market Size Limitations: Small indication scope constrains revenue growth.
• Competition: Mupirocin remains a widely used alternative with established market share.
• Regulatory Barriers: Additional approvals for new indications face lengthy approval timelines.

Investment Opportunities & Considerations

Potential drivers for investment include:

• Pipeline Expansion: If a pharmaceutical company develops new formulations, combination products, or broader indications, revenue could grow.
• Regional Expansion: Regulatory approval in emerging markets with unmet dermatological needs offers upside.
• Strategic Licensing: Partnerships enabling strategic licensing or co-marketing could boost sales.

Risks overshadow these opportunities, given the drug's niche and competitive environment.

Key Takeaways

• Retapamulin is a topical antibiotic with stable global sales, primarily in Europe and select US markets.
• Patent expiration around 2017-2019 has allowed generic competition.
• The overall market for topical antibiotics remains slow-growing; retapamulin’s direct market is limited.
• Growth depends on new indications, regional expansion, or formulations.
• Investment prospects are constrained by competition, small market size, and patent expiration.

Frequently Asked Questions

1. What are the primary drivers for retapamulin’s sales?
Market demand for topical antibiotics treating impetigo remains the main driver, but delayed growth due to competition and small indication scope limits sales potential.

2. How does retapamulin compare to mupirocin?
Mupirocin has a larger market share, broader spectrum of activity, and more extensive insurance coverage, making it a more dominant topical agent.

3. Are there any ongoing development efforts for retapamulin?
There are no known active development programs or reformulations publicly disclosed.

4. What regional markets offer growth potential?
Emerging markets with limited dermatological drug options could grow if regulatory approvals are obtained.

5. What are the key patent considerations?
The original patents expired recently, with secondary patents possibly extending exclusivity until around 2025. Generic entry is expected to increase after patent expiry.

References

[1] MarketsandMarkets. (2022). Topical Antibiotics Market Forecast.