OLUX E Drug Patent Profile

Which patents cover Olux E, and what generic alternatives are available?

Olux E is a drug marketed by Norvium Bioscience and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in OLUX E is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Olux E

A generic version of OLUX E was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for OLUX E

International Patents:	22
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	4,356
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLUX E
DailyMed Link:	OLUX E at DailyMed

Paragraph IV (Patent) Challenges for OLUX E

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLUX E	Emulsion Foam	clobetasol propionate	0.05%	022013	1	2010-02-25

US Patents and Regulatory Information for OLUX E

OLUX E is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No			Y
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No			Y

Expired US Patents for OLUX E

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007

International Patents for OLUX E

See the table below for patents covering OLUX E around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2007111706	СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ
European Patent Office	2438910	Procédé et compositions de micro-émulsion et d'émulsion submicronique (Microemulsion & sub-micron emulsion process & compositions)
Poland	1796636
European Patent Office	1112062	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)
Australia	6069299	Mousse composition
Denmark	1112062

OLUX E Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OLUX-E

Introduction

OLUX-E Foam, a superpotent synthetic corticosteroid, is used in the treatment of moderate to severe atopic dermatitis. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Need and Demand

Atopic dermatitis is a common and chronic skin condition that affects a significant portion of the population. The demand for effective treatments is high, and OLUX-E Foam, with its proven efficacy, fills a critical need in the dermatology market.

Clinical Efficacy and Approval

• OLUX-E Foam has demonstrated statistical superiority over vehicle foam in clinical trials, with 52% of subjects achieving treatment success compared to 14% in the vehicle foam group[4].
• This strong clinical performance supports its market position and demand.

Competitive Landscape

The dermatology market is highly competitive, with various topical corticosteroids available. However, OLUX-E Foam's superpotent formulation and specific indications set it apart.

Market Share and Sales

• While specific sales figures for OLUX-E Foam alone are not readily available, it is part of a broader dermatology product portfolio. Companies like Stiefel Laboratories, which specialize in dermatology products, have seen significant growth and investment in this sector[2].

Pricing and Reimbursement

Pricing for dermatological treatments can be complex, influenced by factors such as insurance coverage, generic competition, and regulatory policies.

Generic Competition

• Unlike simpler generic drugs, complex generics like OLUX-E Foam may not see the typical 85% price drop upon generic entry. Instead, generic price discounts are often in the range of 30-44%[1].
• This moderate price reduction can impact the financial trajectory but still maintains a competitive edge for the brand.

Financial Investments and Partnerships

Companies involved in the development and marketing of OLUX-E Foam often engage in significant financial investments and strategic partnerships.

Private Equity and Funding

• For example, Stiefel Laboratories, a major player in dermatology, received a $500 million minority investment from The Blackstone Group in 2007. This investment was aimed at accelerating product development, licensing, and acquisitions, which could include products like OLUX-E Foam[2].

Research and Development

Continuous investment in research and development (R&D) is crucial for maintaining market position and expanding product lines.

R&D Expenditures

• Companies like Perrigo, which operates in the consumer healthcare and prescription pharmaceuticals sectors, have increased their R&D investments. For instance, Perrigo's Prescription Pharmaceuticals division increased R&D investments by 18% to identify new product opportunities[3].

Regulatory Environment

The regulatory environment plays a significant role in the approval and market entry of complex generics like OLUX-E Foam.

Regulatory Pathways

• Regulatory bodies such as the FDA have been working to improve the approval process for complex generics. Efforts include developing clearer pathways and guidelines to facilitate the entry of these products into the market[1].

Patient Access and Cost Savings

The introduction of generic versions of complex drugs like OLUX-E Foam can significantly impact patient access and healthcare costs.

Potential Savings

• According to estimates, generic competition for complex drugs can yield substantial savings. For example, accelerating the approval of complex generics in the US could result in annual savings between $600 million and $1.7 billion[1].

Market Expansion and International Presence

The global reach of dermatology products, including OLUX-E Foam, is an important aspect of their financial trajectory.

International Markets

• Companies with a strong presence in international markets, such as Stiefel Laboratories, benefit from diverse revenue streams. Expanding into new markets and launching innovative products can further boost sales and growth[2].

Conclusion

OLUX-E Foam operates within a dynamic market influenced by clinical efficacy, regulatory environments, financial investments, and competitive landscapes. Here are the key points:

• Strong Clinical Efficacy: Proven effectiveness in treating atopic dermatitis.
• Competitive Market: Part of a competitive dermatology market with potential for generic competition.
• Financial Investments: Supported by significant investments from private equity and R&D expenditures.
• Regulatory Environment: Impacted by regulatory pathways and guidelines for complex generics.
• Patient Access and Cost Savings: Potential for significant cost savings with generic competition.
• Market Expansion: Benefits from international market presence and expansion.

Key Takeaways

• OLUX-E Foam's market success is driven by its clinical efficacy and strong market demand.
• Financial investments and partnerships are crucial for product development and market expansion.
• The regulatory environment and potential for generic competition influence pricing and market dynamics.
• International market presence and continuous R&D investments are key to long-term financial growth.

FAQs

Q: What is OLUX-E Foam used for? A: OLUX-E Foam is used in the treatment of swelling, redness, and itching associated with moderate to severe atopic dermatitis.

Q: How effective is OLUX-E Foam in clinical trials? A: In clinical trials, 52% of subjects treated with OLUX-E Foam achieved treatment success compared to 14% in the vehicle foam group[4].

Q: What is the impact of generic competition on OLUX-E Foam? A: Generic competition for complex drugs like OLUX-E Foam may result in price discounts of 30-44%, which is less than the typical 85% seen with simpler generics[1].

Q: How do financial investments affect the development of OLUX-E Foam? A: Financial investments, such as the $500 million minority investment in Stiefel Laboratories by The Blackstone Group, support product development, licensing, and acquisitions[2].

Q: What are the potential cost savings with generic competition for complex drugs like OLUX-E Foam? A: Generic competition for complex drugs could yield annual savings between $600 million and $1.7 billion[1].

Sources

1. Potential Savings from Accelerating US Approval of Complex Generics - Accessible Meds, February 2021.
2. Stiefel Laboratories Will Enter Into Private Equity Minority Investment Agreement with The Blackstone Group - The Blackstone Group, August 2007.
3. 2018 Annual Report for Web - Perrigo, February 2019.
4. Clobetasol Propionate - [Product Monograph Template - Standard] - Health Canada, March 2014.