DUAC Drug Patent Profile

When do Duac patents expire, and when can generic versions of Duac launch?

Duac is a drug marketed by Stiefel and is included in one NDA.

The generic ingredient in DUAC is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for DUAC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	53
Drug Prices:	Drug price information for DUAC
DailyMed Link:	DUAC at DailyMed

See drug prices for DUAC

Paragraph IV (Patent) Challenges for DUAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUAC	Gel	benzoyl peroxide; clindamycin phosphate	1% / 5%	050741	1	2008-12-11

US Patents and Regulatory Information for DUAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	AB	RX	Yes	No

Expired US Patents for DUAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002

International Patents for DUAC

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

Country	Patent Number	Title	Estimated Expiration
Canada	2142530	COMPOSITIONS TOPIQUES CONTENANT DU PEROXYDE DE BENZOYLE ET DE LA CLINDAMYCINE, ET METHODE D'UTILISATION (TOPICAL COMPOSITIONS CONTAINING BENZOYL PEROXIDE AND CLINDAMYCIN AND METHOD OF USE THEREOF)

Supplementary Protection Certificates for DUAC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121

DUAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DUAC Topical Gel

Introduction

DUAC Topical Gel, a dual-action acne medication containing clindamycin and benzoyl peroxide, has been a significant player in the dermatology market since its introduction in 2002. Here, we delve into the market dynamics and financial trajectory of this widely used acne treatment.

Market Presence and Expansion

DUAC Topical Gel has established a strong presence globally, particularly in the treatment of inflammatory acne vulgaris. Initially introduced in the U.S. in 2002, it quickly became the fastest-growing topical prescription product for acne treatment[1].

Global Availability

As of 2006, DUAC Topical Gel was available in more than 20 countries, including successful launches in Germany, Spain, the United Kingdom, and Italy. In these markets, it has achieved notable rankings, such as being the number one prescription medication for acne in Germany and Spain, and the number two in the UK[1].

Market Growth and Projections

The acne vulgaris market, in which DUAC operates, is expected to experience substantial growth. According to DelveInsight, the market is projected to grow significantly by 2034, driven by the increasing prevalence of acne cases worldwide, especially among adolescents and young adults[4].

Prevalence and Demand

Approximately 80% of Americans experience acne vulgaris at some point, and it affects 9.4% of the global population. This high prevalence, combined with growing awareness about skincare and beauty standards, fuels the demand for effective acne treatments like DUAC[4].

Competitive Landscape

The acne vulgaris market is competitive, with several key players developing innovative therapies. Companies like Dermata Therapeutics, AstraZeneca, Novartis Pharmaceuticals, UCB Pharma, and Incyte Corporation are working on groundbreaking treatments that could potentially impact DUAC's market share[4].

Innovative Therapies

Emerging therapies such as DMT310, Anifrolumab, CFZ533, Bimekizumab, and Povorcitinib are in various stages of development and could challenge DUAC's dominance in the future. However, DUAC's established reputation and efficacy make it a strong contender in the market[4].

Pricing and Affordability

The cost of DUAC Topical Gel can be significant, with a 45-gram supply costing around $255 for cash-paying customers in the U.S. However, generic versions and discount programs can reduce the cost, such as the Drugs.com discount card which can save up to 80% off prescription medicines[2].

Generic and Discount Options

A generic version of benzoyl peroxide/clindamycin topical gel is available, priced from $50.30 for 25 grams. Additionally, various coupons, copay cards, and rebates can help make DUAC more affordable for patients[2].

Clinical Efficacy and Safety

DUAC Topical Gel has been proven effective in clinical trials. In five randomized, double-blind clinical trials involving 1,319 subjects, DUAC Gel applied once daily was significantly more effective than benzoyl peroxide, clindamycin, and vehicle in reducing inflammatory lesion counts[5].

Safety Considerations

While DUAC is generally safe, it can cause increased sensitivity to sunlight and has been associated with potential carcinogenic effects in animal studies. However, human studies have not shown a significant increase in skin tumors at recommended doses[5].

Economic Impact

The development and pricing of DUAC reflect broader trends in pharmaceutical economics. The shift towards precision medicines and the ability to target small patient populations can change optimal pricing strategies and influence the structure of government research and development incentives[3].

Market Barriers

Despite its success, the acne vulgaris market, including DUAC, faces challenges such as unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. These factors can impact the overall growth and adoption of the drug[4].

Financial Performance

DUAC Topical Gel has been a financial success for Stiefel Laboratories. It has been the company's most successful product, contributing significantly to its revenue. The drug's successful launches in various countries have further bolstered its financial performance[1].

Key Takeaways

• Global Presence: DUAC Topical Gel is available in over 20 countries and has a strong market presence in Europe and the U.S.
• Market Growth: The acne vulgaris market is expected to grow significantly by 2034, driven by increasing prevalence and demand.
• Competitive Landscape: DUAC faces competition from emerging therapies but remains a strong contender due to its established efficacy.
• Pricing and Affordability: The drug is relatively expensive, but generic versions and discount programs can reduce costs.
• Clinical Efficacy: DUAC has been proven effective in reducing inflammatory lesion counts in clinical trials.
• Safety Considerations: It has potential side effects and safety considerations, particularly related to sunlight sensitivity and carcinogenic risks in animal studies.

FAQs

Q: What are the active ingredients in DUAC Topical Gel?

A: DUAC Topical Gel contains clindamycin (1%) and benzoyl peroxide (5%)[1].

Q: How effective is DUAC Topical Gel in treating acne?

A: DUAC Gel has been shown to be significantly more effective than benzoyl peroxide, clindamycin, and vehicle in reducing inflammatory lesion counts in clinical trials[5].

Q: Is DUAC Topical Gel available in generic form?

A: Yes, a generic version of benzoyl peroxide/clindamycin topical gel is available, which can be more affordable[2].

Q: What are the potential side effects of using DUAC Topical Gel?

A: DUAC can cause increased sensitivity to sunlight and has been associated with potential carcinogenic effects in animal studies, although human studies have not shown significant risks at recommended doses[5].

Q: How much does DUAC Topical Gel cost?

A: The cost for DUAC (5%-1%) topical gel is around $255 for a 45-gram supply, but prices can vary depending on the pharmacy and availability of discounts[2].

Sources

1. Stiefel Laboratories Announces Duac Topical Gel Now Available In Italy - Biospace
2. Duac Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER
4. Acne Vulgaris Market to Register Sustainable Growth by 2034 - PR Newswire
5. DUAC (clindamycin phosphate and benzoyl peroxide) Label - FDA