OLUX Drug Patent Profile

When do Olux patents expire, and what generic alternatives are available?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Olux

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

Summary for OLUX

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	4,356
Drug Prices:	Drug price information for OLUX
What excipients (inactive ingredients) are in OLUX?	OLUX excipients list
DailyMed Link:	OLUX at DailyMed

See drug prices for OLUX

Paragraph IV (Patent) Challenges for OLUX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLUX	Topical Foam	clobetasol propionate	0.05%	021142	1	2005-06-27

US Patents and Regulatory Information for OLUX

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	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000		DISCN	Yes	No
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	8,460,641		Y
Norvium Bioscience	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	8,962,000		Y

Expired US Patents for OLUX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	OLUX	clobetasol propionate	AEROSOL, FOAM;TOPICAL	021142-001	May 26, 2000	6,126,920

International Patents for OLUX

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

Country	Patent Number	Title	Estimated Expiration
Portugal	813413
South Korea	100427492
Germany	69630593
Canada	2214436	COMPOSITION PHARMACEUTIQUE CONTENANT UN CORTICOSTEROIDE (CORTICOSTEROID-CONTAINING PHARMACEUTICAL COMPOSITION)
Brazil	9607687
Australia	709320
Czech Republic	285913	Farmaceutická kompozice obsahující kortikosteroid (PHARMACEUTICAL COMPOSITION CONTAINING CORTICOSTEROID)

OLUX Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for OLUX

Introduction to OLUX

OLUX, also known as clobetasol topical, is a potent topical steroid used to treat various dermatological conditions, including atopic dermatitis, dermatitis, and other skin disorders. Understanding the market dynamics and financial trajectory of OLUX is crucial for both patients and healthcare providers.

Market Position and Competition

OLUX is a brand-name drug, but it also has a generic version available, which significantly impacts its market dynamics. The generic version of clobetasol topical foam is priced substantially lower than the brand-name version, with prices starting from around $59.48 for a 50-gram supply, compared to the brand-name OLUX which costs approximately $266 for the same quantity[2].

This price difference creates a competitive environment where generic alternatives can capture a significant market share. For instance, when generic versions of complex drugs like Advair Diskus® were introduced, they captured more than half of the market share within a year[1].

Price Trends and Increases

The pharmaceutical market, particularly for dermatology drugs, has seen steep price increases over the years. While OLUX has not experienced the extreme price jumps seen with some other dermatology drugs (such as Targretin gel or Carac cream), it still remains a costly option for many patients. The price of OLUX and similar drugs has increased, although not as dramatically as some other medications, which have seen increases of up to 1,700% over six years[5].

Generic Competition and Savings

The introduction of generic versions of OLUX and other complex generics can lead to significant savings for patients, Medicare, Medicaid, and commercial payors. For example, accelerating the approval of complex generics in the US could yield annual savings between $600 million and $1.7 billion, with a median savings estimate of $1.3 billion[1].

Regulatory Environment

The FDA plays a crucial role in the approval and regulation of generic drugs, including those like OLUX. Efforts to encourage generic competition for complex products, such as OLUX, are ongoing. Former FDA Commissioner Scott Gottlieb emphasized the need to get generic copies of complex drugs to market, highlighting the large category of brand drugs that are off-patent and off-exclusivities but not yet subject to brisk generic competition[1].

Patient Assistance Programs

Given the high costs associated with brand-name drugs like OLUX, patient assistance programs become vital. Many pharmaceutical companies offer these programs to help patients afford their medications. For OLUX, patients can explore these programs through the manufacturer or by contacting their doctor’s office to get in touch with someone at the patient assistance program[5].

Pharmacy and Compounding Options

Pharmacies also play a role in reducing costs for patients. Some pharmacies offer discounted prices for compounded versions of drugs like OLUX. Additionally, groups such as the Patient Advocate Foundation can help patients navigate ways to lower their medical bills, including prescription drug costs[5].

Financial Impact on Healthcare Spending

While the cost of prescription drugs, including OLUX, can be high, they make up only about 10% of all healthcare spending. However, the financial impact on individual patients can be significant. The availability of generic versions and patient assistance programs can help mitigate these costs[5].

Manufacturer Strategies

Companies like Perrigo, which has been involved in the development and marketing of generic versions of topical steroids, have seen success in expanding their product lines and improving their market position. For instance, Perrigo received tentative approval for a generic version of OLUX (clobetasol foam) and has been investing in research and development to maintain its leadership in the generic pharmaceutical market[4].

Global Market Dynamics

The market dynamics for OLUX and similar drugs can vary globally. In regions like Mexico and the UK, the market for over-the-counter (OTC) and generic drugs is different from that in the US. For example, Perrigo has a significant market share in Mexico for certain OTC products, and in the UK, store brands often dominate the market[4].

Future Outlook

The future outlook for OLUX and its generic counterparts is promising, especially with ongoing efforts to increase generic competition. As more complex products lose their patent and exclusivity protections, the potential for significant savings and increased patient access becomes more pronounced. Policymakers and regulatory bodies are likely to continue focusing on facilitating a more robust complex generic marketplace, which could lead to better affordability and access to essential medications like OLUX[1].

Key Takeaways

• Generic Competition: The availability of generic versions of OLUX significantly reduces costs for patients.
• Regulatory Environment: FDA approval processes are crucial for bringing generic versions to market.
• Patient Assistance: Programs offered by manufacturers and advocacy groups can help patients afford medications.
• Pharmacy Options: Compounding pharmacies and discounted prices can further reduce costs.
• Financial Impact: While prescription drugs are a small portion of healthcare spending, individual costs can be high.
• Manufacturer Strategies: Companies are investing in R&D to expand their generic product lines.

FAQs

Q: What is the difference in cost between the brand-name OLUX and its generic version? A: The brand-name OLUX costs around $266 for a 50-gram supply, while the generic version costs approximately $59.48 for the same quantity[2].

Q: How does the introduction of generic versions impact the market share of brand-name drugs? A: Generic versions can capture a significant market share quickly, as seen with drugs like Advair Diskus®, which captured more than half of the market share within a year of launching[1].

Q: What are the potential savings from increasing generic competition for complex drugs like OLUX? A: Accelerating the approval of complex generics could yield annual savings between $600 million and $1.7 billion, with a median savings estimate of $1.3 billion[1].

Q: How can patients afford expensive medications like OLUX? A: Patients can explore patient assistance programs, ask about generics, and look into pharmacy compounding options to reduce costs[5].

Q: What role does the FDA play in the approval of generic drugs like OLUX? A: The FDA is crucial in approving generic drugs and facilitating a more robust complex generic marketplace, which can increase patient access and lower drug spending[1].

Sources

1. Potential Savings from Accelerating US Approval of Complex Generics - Accessible Meds
2. Olux Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Annual Report - Perrigo Company plc
4. Meeting the World's Growing Need for Quality, Affordable Healthcare Products - Perrigo Annual Report
5. Steep Price Increases Hit Patients Using Dermatology Drugs - Council for Affordable Health Coverage