Retapamulin - Generic Drug Details

What are the generic sources for retapamulin and what is the scope of freedom to operate?

Retapamulin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are two patents 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:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	1,254
What excipients (inactive ingredients) are in retapamulin?	retapamulin excipients list
DailyMed Link:	retapamulin at DailyMed

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

Constraining patent/regulatory exclusivity:

7,875,630

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
New York University School of Medicine	Phase 3
NYU Langone Health	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	7,875,630			Y
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007		DISCN	Yes	No	8,207,191

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	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 retapamulin

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 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
Germany	602004024417
Japan	5685156
European Patent Office	1663220	NOUVEAU PROCEDE POUR LA FABRICATION DE DERIVES DE LA PLEUROMUTILINE (NOVEL PROCESS FOR THE PREPARATION OF PLEUROMUTILIN DERIVATIVES)

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

Retapamulin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Retapamulin

Overview of Retapamulin

Retapamulin, marketed under the brand name Altabax, is a topical antibiotic agent used primarily for the treatment of impetigo caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes. It was approved by the FDA in April 2007 and is classified as a semisynthetic pleuromutilin antibiotic[5].

Market Size and Growth Rate

The global retapamulin market is anticipated to experience steady growth over the coming years. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2022 to 2031, driven by increasing demand for effective topical antibiotic treatments for skin infections[4].

Historical Growth

• The market has shown a consistent growth pattern, with significant increases in demand observed between 2017 and 2021. This growth can be attributed to the rising incidence of skin infections and the need for targeted, effective treatments[1].

Future Projections

• By 2032, the retapamulin market is projected to reach a substantial valuation, driven by ongoing research and development in the pharmaceutical sector and the expanding global healthcare market[3].

Competitive Landscape

The retapamulin market is characterized by a competitive landscape dominated by a few key players.

Major Players

• GlaxoSmithKline (GSK) is the primary manufacturer and marketer of retapamulin under the brand name Altabax. GSK's strong market presence and distribution network contribute significantly to the drug's market share[5].

Market Share

• While GSK holds a significant portion of the market, other pharmaceutical companies are also entering the scene with generic versions of retapamulin, which could potentially alter the market dynamics in the future.

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics of retapamulin.

FDA Approval

• Retapamulin was approved by the FDA in 2007, and since then, it has been subject to various regulatory oversight and compliance requirements. The FDA approval has been a key factor in the drug's acceptance and use in clinical settings[5].

Patent Landscape

• The patent landscape for retapamulin includes several patents that have expired or are nearing expiration. For example, key patents in the US expired in 2021, which could lead to increased competition from generic versions[5].

Financial Performance

Revenue Trends

• The revenue generated from retapamulin sales has been stable, with a gradual increase over the years. This stability is due to the consistent demand for the drug in treating impetigo and other skin infections.

Cost Structure

• The cost structure for retapamulin includes manufacturing costs, research and development expenses, marketing expenditures, and regulatory compliance costs. GSK, as the primary manufacturer, has a well-established cost structure that supports the drug's production and distribution[2].

Market Drivers

Several factors drive the growth and financial trajectory of the retapamulin market.

Increasing Incidence of Skin Infections

• The rising incidence of skin infections, particularly impetigo, is a significant driver. As the global population grows and urbanization increases, the prevalence of such infections is expected to rise, driving demand for effective treatments like retapamulin[3].

Advancements in Healthcare

• Improvements in healthcare infrastructure and access to medical services in developing countries are also driving the market. Better diagnostic capabilities and increased awareness of skin infections contribute to higher demand for retapamulin[4].

Market Challenges

Despite the growth potential, the retapamulin market faces several challenges.

Competition from Generic Versions

• The expiration of key patents has opened the market to generic versions of retapamulin, which could reduce the market share of branded products like Altabax[5].

Regulatory Hurdles

• Stringent regulatory requirements and the need for continuous compliance can pose challenges for manufacturers. Any changes in regulatory policies could impact the market dynamics significantly[2].

Financial Projections

Revenue Projections

• By 2032, the global retapamulin market is expected to achieve a substantial revenue, driven by the increasing demand and the expanding healthcare market. The revenue is projected to grow steadily, reflecting a CAGR of 3 to 5 percent[4].

Profit Margins

• Profit margins for retapamulin are expected to remain stable, influenced by the balance between manufacturing costs, market competition, and pricing strategies. As generic versions enter the market, there may be pressure on profit margins, but brand loyalty and the drug's efficacy are likely to maintain a competitive edge[3].

Key Takeaways

• Market Growth: The retapamulin market is expected to grow at a CAGR of 3 to 5 percent from 2022 to 2031.
• Competitive Landscape: GSK dominates the market, but generic versions are expected to increase competition.
• Regulatory Environment: FDA approval and patent expirations are key factors influencing market dynamics.
• Financial Performance: Revenue is expected to increase steadily, with stable profit margins despite competition.
• Market Drivers: Increasing incidence of skin infections and advancements in healthcare drive the market.

FAQs

What is retapamulin used for?

Retapamulin is used for the treatment of impetigo caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes[5].

Who is the primary manufacturer of retapamulin?

GlaxoSmithKline (GSK) is the primary manufacturer and marketer of retapamulin under the brand name Altabax[5].

What is the expected CAGR of the retapamulin market from 2022 to 2031?

The retapamulin market is expected to grow at a CAGR of 3 to 5 percent from 2022 to 2031[4].

What are the major challenges facing the retapamulin market?

The major challenges include competition from generic versions, regulatory hurdles, and potential pressure on profit margins[2][5].

When was retapamulin approved by the FDA?

Retapamulin was approved by the FDA in April 2007[5].

Sources

1. Retapamulin Market Size, Competitive Landscape, Upcoming Trends and Forecast Up To 2032. Southeast News Channel Nebraska.
2. CONCORD BIOTECH LIMITED - Citigroup. Citigroup.
3. Global Retapamulin Market Report | Global Forecast From 2023 To 2032. DataIntelo.
4. Global retapamulin market size and forecast. Market Research Intellect.
5. Retapamulin: Uses, Interactions, Mechanism of Action - DrugBank. DrugBank.