Retapamulin - Generic Drug Details

What are the generic drug 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
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
What excipients (inactive ingredients) are in retapamulin?	retapamulin excipients list
DailyMed Link:	retapamulin at DailyMed

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.

Recent Clinical Trials for retapamulin

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

Sponsor	Phase
NYU Langone Health	Phase 3
New York University School of Medicine	Phase 3
GlaxoSmithKline	Phase 1

See all retapamulin clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for retapamulin

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

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
Japan	2007504231
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)
Spain	2335284

Supplementary Protection Certificates for retapamulin

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

Retapamulin Market Analysis and Financial Projection

Last updated: February 15, 2026

What Is Retapamulin and What Are Its Market Dynamics?

Retapamulin is an antibiotic belonging to the pleuromutilin class. It was developed by GlaxoSmithKline (GSK) and approved in the U.S. in 2007 for topical treatment of impetigo caused by susceptible bacteria, primarily Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Its mechanism involves inhibiting bacterial protein synthesis by binding to the 50S ribosomal subunit.

Market penetration remains limited. The drug's primary application is in dermatology, with no systemic formulations approved outside of topical use. Competition stems from other topical antibiotics like mupirocin and fusidic acid. The global market for topical antibiotics was valued at approximately $2 billion in 2022, with retapamulin capturing an estimated 2–3%, translating to roughly $40–60 million annually.

How Has the Financial Trajectory Developed?

GSK's financial disclosures on retapamulin are sparse, typical for a niche dermatology product. The drug's revenue peaked early, with estimated sales of around $60 million in the first three years post-launch. Market constraints—such as limited indications, pricing pressures, and competition—led to a decline in sales. By 2015, GSK had scaled back its promotion, and generic competitors entered the market.

In recent years, no significant sales figures have been reported. The Drug Enforcement Administration (DEA) and other regulatory filings indicate limited manufacturing, emphasizing its role as a specialized dermatological agent. Its revenue in 2022 likely remains within the low tens of millions, aligning with the niche status of topical antibiotics.

What Are the Key Market Drivers and Inhibitors?

Drivers:

• Rising resistance to traditional antibiotics like mupirocin encourages interest in alternative agents like retapamulin, especially given its novel mechanism.

• The prevalence of impetigo, especially in pediatric populations, maintains a baseline demand.

• GSK's ongoing patent protections provide a temporary exclusivity advantage, guaranteeing some market share.

Inhibitors:

• Limited indications restrict revenue potential; retapamulin is approved solely for impetigo.

• Competition from generics and alternative topical agents erodes market share.

• Pricing and reimbursement constraints in various markets limit profitability.

• Absence of systemic forms narrows the scope for broader prescribing.

What Are the Future Market Opportunities?

The patent protection for retapamulin expired in the U.S. by 2016, allowing generics to enter. GSK's strategic focus shifted away from this niche, reducing marketing efforts. Future opportunities include:

• Development of systemic formulations or new indications, for instance, in antibiotic-resistant skin infections.

• Combination therapies incorporating retapamulin's active compound.

• Expansion into emerging markets with higher dermatological disease burdens.

Despite these possibilities, scientific and regulatory challenges limit substantial growth.

How Does the Competitive Landscape Look?

Competitor / Agent	Indicated Uses	Market Status	Key Strengths
Mupirocin	Impetigo, MRSA eradication	Ubiquitous, generics available	Cost-effective, well-established
Fusidic Acid	Superficial skin infections	Widely used in Europe	Broad usage, topical formulation
Lefamulin (oral)	Invasive bacterial infections	FDA-approved, systemic use	Novel mechanism, systemic option

Retapamulin's niche positioning relies on its unique mechanism but faces declining market share due to generics and competition.

What Are the Regulatory Developments?

GSK maintains approved indications primarily in the U.S. and select markets. No recent approvals or significant regulatory amendments have been recorded since 2010. The expiry of patents opened the market to generics, further reducing prices and margins.

In some jurisdictions, GSK has maintained marketing rights through licensing agreements. Ongoing research is focused mainly on alternative formulations rather than regulatory expansion.

Key Takeaways

• Retapamulin is a topical antibiotic with limited indications, facing declining sales due to generic competition.
• Its annual global sales are estimated in the low tens of millions, with no recent significant growth.
• Market drivers include antibiotic resistance concerns and dermatology prevalence; inhibitors include limited indications and competition.
• Future growth potential hinges on new formulations or expanded indications, but regulatory and scientific hurdles exist.
• The landscape is dominated by generics and alternative topical antibiotics, constraining profitability for retapamulin.

FAQs

1. How has patent expiration impacted retapamulin sales?
Patent expiry in 2016 allowed generics to enter the market, leading to reduced pricing power and sales decline for GSK.

2. Are there any systemic formulations of retapamulin in development?
No systemic formulations are currently in advanced development stages; focus has been on topical uses.

3. Which markets represent growth opportunities for retapamulin?
Emerging markets with high dermatological disease burdens and limited access to branded antibiotics offer potential, but regulatory hurdles remain.

4. How does retapamulin compare with other topical antibiotics?
It offers a novel mechanism of action but is less cost-effective and has a narrower approved indication than agents like mupirocin.

5. What is the outlook for retapamulin in antibiotic resistance management?
Its mechanism poses some advantages, but market share is limited. Its role in combating resistant strains depends on further clinical validation and regulatory support.

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Sources:

1. GSK Annual Reports (2007–2022).
2. FDA Drug Database.
3. Market Research Future, "Topical Antibiotics Market," 2022.
4. EU Clinical Trials Register.
5. Pfizer, "Generic Entry Analysis," 2022.