SILDAFLO Drug Patent Profile

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

Sildaflo is a drug marketed by Franklin Pharms and is included in one NDA.

The generic ingredient in SILDAFLO is silver sulfadiazine. There are twenty-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the silver sulfadiazine profile page.

Summary for SILDAFLO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	137
Patent Applications:	4,303
DailyMed Link:	SILDAFLO at DailyMed

US Patents and Regulatory Information for SILDAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989		DISCN	No	No

Expired US Patents for SILDAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989

International Patents for SILDAFLO

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

Country	Patent Number	Title	Estimated Expiration
Israel	73188	SYNTHETIC RESIN WOUND DRESSING
Australia	563517
South Korea	920005822
Spain	8704345

Supplementary Protection Certificates for SILDAFLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	SPC/GB03/034	United Kingdom		PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313

SILDAFLO Market Analysis and Financial Projection Experimental

Sildenafil Drug Market: Dynamics and Financial Trajectory

Introduction

Sildenafil, widely known by its brand name Viagra, is a phosphodiesterase type 5 (PDE5) inhibitor used primarily to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). The market for sildenafil has been growing steadily, driven by several key factors. Here, we delve into the market dynamics and the financial trajectory of the sildenafil drug market.

Market Size and Growth

The sildenafil drug market is projected to experience significant growth in the coming years. By 2030, the market is expected to reach approximately US$ 4.56 billion, up from US$ 2.90 billion in 2023, with a compound annual growth rate (CAGR) of 6.7% during the forecast period[1][2].

Key Drivers

Several factors are driving the growth of the sildenafil market:

Rising Prevalence of Erectile Dysfunction

The increasing prevalence of ED among men across various age groups is a major driver. This is exacerbated by lifestyle factors such as obesity, diabetes, and smoking[1].

Growing Geriatric Population

The aging population is more prone to ED, contributing to the demand for sildenafil and other ED treatments[1].

Increasing Awareness and Acceptance

Public awareness campaigns and the wider availability of ED medications have reduced the stigma associated with seeking treatment, leading to higher adoption rates[1][3].

Generic Competition

The expiration of patents for branded drugs has led to a surge in generic versions, which are more affordable and thus in higher demand globally[1][2].

Market Segmentation

The sildenafil market is segmented into several categories:

By Drug Type

• Branded Drugs: Although still popular, their market share is decreasing due to patent expirations.
• Generics: Currently the largest segment, generics are expected to continue growing due to their affordability.
• Over-the-Counter (OTC) Drugs: Emerging as a convenient option, OTC drugs are gaining traction[1].

By Indication

• Erectile Dysfunction (ED)
• Pulmonary Arterial Hypertension (PAH)

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies: Increasingly popular due to convenience and privacy[2][3].

By Dosage Form

• 50mg/Tablets
• 100mg/Tablets
• Others: Including topical gels and other formulations[2].

Regional Insights

The market is geographically diverse, with different regions exhibiting unique growth patterns:

North America

Currently the dominant region, North America benefits from high medical awareness, the presence of major pharmaceutical manufacturers, and reduced price points following the introduction of generics[1].

Asia Pacific

Expected to emerge as the most lucrative territory, the Asia Pacific region is driven by improving healthcare access in countries like China and India, along with rising standards of living. Telemedicine platforms and new ED medications are also fueling growth in this region[1][3].

Market Opportunities

Several opportunities are present in the sildenafil market:

Emerging Markets

Countries with large patient pools and improving healthcare infrastructure offer significant growth potential. Educational campaigns and the wider availability of ED medications through online providers and hospital pharmacies are increasing awareness and accessibility[3].

New Drug Formulations

Recent approvals, such as the FDA clearance for Futura Medical's Eroxon, a topical ED gel for OTC marketing, indicate a trend towards more convenient and accessible treatment options[3].

Telehealth Integration

Partnerships between pharmaceutical companies and telehealth clinics, such as Pfizer's partnership to offer generic Viagra, are expanding the reach of ED treatments[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Social Stigma

The social stigma associated with ED continues to restrict many patients from openly seeking medical help, acting as a growth barrier[1].

Alternative Treatments

The availability of alternative treatment modes like penile implants and counseling poses competition to sildenafil and other ED medications[1].

Price Wars

Maintaining brand loyalty amid intense price wars, especially with the rise of generics, is a significant challenge for pharmaceutical companies[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the sildenafil market:

Increased Risk of ED

The pandemic increased the risk of ED by nearly six times in men with a history of COVID-19, according to the National Library of Medicine. This has contributed to higher demand for ED medications[3].

Limited Healthcare Access

However, limited healthcare access and drug recalls during the pandemic have hindered market growth to some extent[3].

Key Players

The sildenafil market is dominated by several major pharmaceutical companies, including:

• Pfizer
• Teva Pharmaceuticals
• Aurobindo Pharma
• Alembic Pharmaceuticals
• Torrent Pharmaceuticals
• Lupin
• Dr Reddy’s Laboratories
• Zydus Cadila
• Amneal Pharmaceuticals
• Hetero
• Apotex
• Mylan
• Ajanta Pharma
• Sun Pharmaceutical
• Cipla
• Novartis
• Eli Lily
• Sanofi
• Bayer
• GlaxoSmithKline[1].

Future Outlook

The future of the sildenafil market looks promising, driven by advancements in medical technology, growing focus on sexual wellness, and increasing awareness about ED treatment options.

Technological Advancements

New drug formulations and regulatory approvals are expected to fuel market growth. For instance, the recent FDA approval of a topical ED gel for OTC sales marks a significant step forward in convenience and accessibility[3].

Growing Awareness

Public awareness about ED medications is on the rise, driven by educational campaigns and the wider availability of these medications through various distribution channels[3].

Key Takeaways

• The sildenafil market is projected to reach US$ 4.56 billion by 2030, growing at a CAGR of 6.7%.
• Key drivers include the rising prevalence of ED, growing geriatric population, increasing awareness, and generic competition.
• North America is the current dominant region, while Asia Pacific is expected to emerge as the most lucrative territory.
• Emerging markets, new drug formulations, and telehealth integration present significant opportunities.
• Social stigma and alternative treatments remain challenges.

FAQs

What is the expected market size of the sildenafil drug market by 2030?

The sildenafil drug market is expected to reach approximately US$ 4.56 billion by 2030[1].

What is the CAGR of the sildenafil drug market from 2023 to 2030?

The sildenafil drug market is expected to exhibit a CAGR of 6.7% from 2023 to 2030[1].

What are the key segments of the sildenafil market?

The key segments include drug type (branded, generics, OTC), indication (ED, PAH), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and dosage form (50mg/tablets, 100mg/tablets, others)[1][2].

What are the driving factors of the sildenafil market?

The driving factors include increasing prevalence of ED, growing geriatric population, increasing awareness and acceptance, and generic competition[1][2].

How has the COVID-19 pandemic impacted the sildenafil market?

The COVID-19 pandemic has increased the risk of ED, contributing to higher demand, but also limited healthcare access and drug recalls have hindered market growth[3].

Sources

1. Coherent Market Insights: Sildenafil Drug Market Size & Share Analysis - Growth Trends.
2. Business Research Insights: Sildenafil Market Size, Industry Trend & Analysis By 2032.
3. SNS Insider: Erectile Dysfunction Treatment Drugs Market Size, Share 2032.