CONDYLOX Drug Patent Profile

Which patents cover Condylox, and when can generic versions of Condylox launch?

Condylox is a drug marketed by Allergan and Teva Branded Pharm and is included in two NDAs.

The generic ingredient in CONDYLOX is podofilox. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the podofilox profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Condylox

A generic version of CONDYLOX was approved as podofilox by PADAGIS US on January 29^th, 2002.

Summary for CONDYLOX

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	1
Patent Applications:	4,756
Drug Prices:	Drug price information for CONDYLOX
What excipients (inactive ingredients) are in CONDYLOX?	CONDYLOX excipients list
DailyMed Link:	CONDYLOX at DailyMed

See drug prices for CONDYLOX

Recent Clinical Trials for CONDYLOX

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

Sponsor	Phase
Hyloris Developments SA	Phase 3
bioRASI, LLC	Phase 3
Dermax SA	Phase 3

See all CONDYLOX clinical trials

Pharmacology for CONDYLOX

Physiological Effect

Decreased Mitosis

US Patents and Regulatory Information for CONDYLOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	CONDYLOX	podofilox	GEL;TOPICAL	020529-001	Mar 13, 1997	AB	RX	Yes	Yes
Teva Branded Pharm	CONDYLOX	podofilox	SOLUTION;TOPICAL	019795-001	Dec 13, 1990	AT	RX	Yes	Yes

Expired US Patents for CONDYLOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	CONDYLOX	podofilox	GEL;TOPICAL	020529-001	Mar 13, 1997	4,680,399
Allergan	CONDYLOX	podofilox	GEL;TOPICAL	020529-001	Mar 13, 1997	5,057,616

International Patents for CONDYLOX

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

Country	Patent Number	Title	Estimated Expiration
Germany	3583043
Finland	84557
Austria	63916
Canada	1268709	PROCEDE D'ISOLEMENT ET DE PURIFICATION DE LA PODOPHYLLOTOXINE (PROCESS FOR THE ISOLATION AND PURIFICATION OF PODOPHYLLOTOXIN)
United Kingdom	8424269
European Patent Office	0316964	PROCESS FOR THE PURIFICATION OF PODOPHYLLOTOXIN

CONDYLOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Condylox

Market Overview

Condylox, a brand name for the drug podofilox, is a key player in the genital warts treatment market. This market is experiencing significant growth driven by various factors, including increasing awareness about sexually transmitted diseases, the effectiveness of treatment options, and advancements in healthcare infrastructure.

Market Size and Growth

The global genital warts treatment market, which includes Condylox, is projected to grow substantially in the coming years. By 2024, the market is estimated to be valued at around USD 1.91 billion and is expected to reach USD 2.72 billion by 2031, growing at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031[4].

Drug Type Analysis

In the genital warts treatment market, podofilox, the active ingredient in Condylox, is one of the leading drug types. Alongside imiquimod, podophyllin, and trichloroacetic acid, podofilox holds a significant market share. Specifically, imiquimod leads with a 38% market share, but podofilox remains a crucial treatment option due to its efficacy and safety profile[1].

Treatment Analysis

Condylox falls under the category of chemical destruction treatments, which are widely used for genital warts. Chemical destruction techniques, including those using podofilox, currently hold a substantial share of the market, with physical destruction methods also being prominent. Chemical destruction techniques account for a significant portion of the market, with physical destruction methods holding around 45% of the market share[1].

Distribution Channel Analysis

The distribution of Condylox and other genital warts treatments is primarily through hospital pharmacies, which currently hold around 49% of the market share. Retail pharmacies and online pharmacies also play important roles, but hospital pharmacies remain the dominant channel due to the need for professional medical advice and treatment[1].

Regional Analysis

North America dominates the global genital warts treatment market, including the market for Condylox, with an estimated market share of around 38% to 40.2%. This dominance is attributed to strong healthcare infrastructure, high awareness levels about sexually transmitted diseases, and the presence of leading pharmaceutical companies such as Merck & Co.[1][4].

Efficacy and Clinical Studies

Condylox has been proven effective in clinical studies. In a multicenter clinical study, Condylox Gel 0.5% showed a complete clearing of wart tissue in 38.4% of patients after four weeks of treatment. Similar clearance rates were observed in another clinical trial, highlighting the drug's efficacy in treating genital warts[2][5].

Mechanism of Action and Pharmacokinetics

Condylox works by causing necrosis of visible wart tissue, although the exact mechanism of action is unknown. Systemic absorption studies have shown that topical application of podofilox does not result in detectable serum levels in most cases, and the drug does not accumulate after multiple treatments. The elimination half-life ranges from 1.0 to 4.5 hours[2][5].

Adverse Reactions and Side Effects

While Condylox is generally well-tolerated, it can cause local adverse reactions such as pain, itching, and burning at the application site. These reactions are predominantly mild or moderate and do not increase during the treatment period. Severe reactions are most frequent within the first two weeks of treatment[2].

Market Drivers and Trends

The growth of the genital warts treatment market, including the demand for Condylox, is driven by several factors:

• Increasing awareness about sexually transmitted diseases.
• Effective drugs and medicines available for treatment.
• Developing healthcare infrastructure in emerging nations.
• Technological innovations and the rise of telemedicine and digital health solutions[3][4].

Challenges and Restraints

Despite the growth, the market faces challenges such as:

• Social stigma associated with genital warts.
• Preference of patients towards non-drug therapies.
• Patent expirations of major drugs, which can impact market growth[4].

Key Takeaways

• Market Growth: The genital warts treatment market, including Condylox, is expected to grow at a CAGR of around 5.2% from 2024 to 2031.
• Efficacy: Condylox has shown significant efficacy in clinical studies, with a complete clearing of wart tissue in a substantial percentage of patients.
• Distribution: Hospital pharmacies are the primary distribution channel, holding around 49% of the market share.
• Regional Dominance: North America leads the global market due to strong healthcare infrastructure and high awareness levels.

FAQs

What is Condylox used for?

Condylox (podofilox) is used for the topical treatment of anogenital warts (external genital warts and perianal warts)[2].

How effective is Condylox in treating genital warts?

Condylox has been shown to completely clear wart tissue in around 38.4% of patients after four weeks of treatment in clinical studies[2].

What are the common side effects of Condylox?

Common side effects include local adverse reactions such as pain, itching, and burning at the application site, which are predominantly mild or moderate[2].

Which region dominates the market for Condylox?

North America dominates the global genital warts treatment market, including the market for Condylox, due to strong healthcare infrastructure and high awareness levels about sexually transmitted diseases[1][4].

What is the expected market size for the genital warts treatment market by 2031?

The global genital warts treatment market is expected to reach around USD 2.72 billion by 2031[4].

Sources:

1. Market.us: Genital Warts Treatment Market Size, Share | CAGR of 4.9% - Market.us Report.
2. Drugs.com: Condylox: Package Insert / Prescribing Information - Drugs.com.
3. ResearchandMarkets.com: Condyloma Acuminata Treatment Global Market Report 2024.
4. Coherent Market Insights: Genital Warts Treatment Market - Price, Size, Share & Growth.
5. RxList: Condylox Topical (Podofilox Topical Solution ) - RxList.