SILVER SULFADIAZINE - Generic Drug Details

What are the generic sources for silver sulfadiazine and what is the scope of patent protection?

Silver sulfadiazine is the generic ingredient in five branded drugs marketed by King Pharms Llc, Dr Reddys La, Thepharmanetwork Llc, and Franklin Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for silver sulfadiazine. Eighteen suppliers are listed for this compound.

Summary for SILVER SULFADIAZINE

US Patents:	0
Tradenames:	5
Applicants:	4
NDAs:	4
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	18
Patent Applications:	7,279
Drug Prices:	Drug price trends for SILVER SULFADIAZINE
What excipients (inactive ingredients) are in SILVER SULFADIAZINE?	SILVER SULFADIAZINE excipients list
DailyMed Link:	SILVER SULFADIAZINE at DailyMed

See drug prices for SILVER SULFADIAZINE

See drug sales revenues for SILVER SULFADIAZINE

Recent Clinical Trials for SILVER SULFADIAZINE

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

Sponsor	Phase
Skingenix, Inc.	Phase 2
OHSU Knight Cancer Institute	N/A
Oregon Health and Science University	N/A

See all SILVER SULFADIAZINE clinical trials

Pharmacology for SILVER SULFADIAZINE

Drug Class

Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for SILVER SULFADIAZINE

Anti-Infective Agents, Local

Anatomical Therapeutic Chemical (ATC) Classes for SILVER SULFADIAZINE

D06BA	Sulfonamides
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D08AL	Silver compounds
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SILVER SULFADIAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thepharmanetwork Llc	THERMAZENE	silver sulfadiazine	CREAM;TOPICAL	018810-001	Dec 23, 1985	AB	RX	No	No
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989		DISCN	No	No
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Dr Reddys La	SSD AF	silver sulfadiazine	CREAM;TOPICAL	018578-003	Jul 11, 1990		DISCN	No	No
Dr Reddys La	SSD	silver sulfadiazine	CREAM;TOPICAL	018578-001	Feb 25, 1982	AB	RX	Yes	Yes

Expired US Patents for SILVER SULFADIAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381-001	Approved Prior to Jan 1, 1982	3,761,590
Franklin Pharms	SILDAFLO	silver sulfadiazine	DRESSING;TOPICAL	019608-001	Nov 30, 1989	4,563,184

SILVER SULFADIAZINE Market Analysis and Financial Projection Experimental

Silver Sulfadiazine Market Dynamics and Financial Trajectory

Market Overview

The silver sulfadiazine market is poised for significant growth, driven by the increasing demand for effective treatments for burn injuries and other wound care needs. Here are the key dynamics and financial projections for this market.

Growing Demand for Burn Care

Burn injuries are a severe healthcare problem, resulting in approximately 180,000 deaths annually, mostly in emerging economies, according to the World Health Organization[1][3]. This high mortality and morbidity rate has led to an increased demand for anti-burn creams and lotions, which is expected to drive the market growth for silver sulfadiazine.

Mechanism of Action and Uses

Silver sulfadiazine is a topical sulfonamide antibiotic that acts on the bacterial cell wall and cell membrane, making it an effective treatment for second- and third-degree burns. It is also used to prevent the growth of bacteria and yeast on the skin[4].

Market Size and Growth Projections

The global silver sulfadiazine market is expected to grow substantially during the forecast period. By 2030, the market is projected to reach $3,279.8 million, growing at a Compound Annual Growth Rate (CAGR) of 5.20% from 2024 to 2030[5].

Regional Market Analysis

North America

North America is anticipated to hold the largest market share during the forecast period. This is due to the high incidence of burn cases and the increasing demand for wound-care products. According to the National Fire Protection Association (NFPA), a civilian dies from fire outbreaks every two hours, which has increased the demand for wound-care products in this region[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth, driven by the increasing demand from emerging economies such as India and China. Countries like Australia, China, and India are emerging as new revenue generators in this region[1].

Market Players

Key players in the global silver sulfadiazine market include 3M Company, Baxter International, Inc., Monarch Pharmaceuticals, Teva Pharmaceutical Industries Ltd, and Johnson & Johnson Limited. These companies are investing in research and development to enhance the efficacy and safety of silver sulfadiazine products[1].

Cost-Effectiveness and Treatment Options

Studies have compared the cost-effectiveness of silver sulfadiazine with other treatment options like enclosed silver dressings. For partial-thickness burn patients, enclosed silver dressings were found to be cost-effective, especially when the complication rate for silver sulfadiazine is high. The incremental cost-utility ratio for enclosed silver dressings relative to silver sulfadiazine was $40,167.99 per Quality-Adjusted Life Year (QALY)[2].

Challenges and Restraints

Despite the growth potential, the market faces several challenges. Silver sulfadiazine can cause minor side effects such as nausea, loss of appetite, and dizziness, which may hinder demand. Additionally, the increasing price of silver, a key raw material, is expected to impact the production costs and subsequently restrain market growth[1][3].

Financial Analysis

The financial trajectory of the silver sulfadiazine market is influenced by various factors, including the cost of raw materials, research and development expenditures, and the pricing strategies of market players.

• Revenue Forecast: The market is expected to reach $3,279.8 million by 2030, with a CAGR of 5.20% from 2024 to 2030[5].
• Cost Analysis: The cost of silver sulfadiazine products varies widely depending on the brand and packaging. For example, Silvadene 1% cream can range from $13.99 for a 25 gm jar to $73.48 for a 400 gm jar[4].
• Supplier and Buyer Bargaining Power: The market analysis indicates that suppliers have moderate bargaining power due to the availability of multiple brands, while buyers have significant bargaining power due to the competitive nature of the market[5].

Market Opportunities and Trends

The silver sulfadiazine market is driven by continuous research and development endeavors by pharmaceutical companies. The increasing focus on wound care and the need for effective antibacterial treatments are key trends shaping the market. Additionally, government initiatives to fund research and development of medicines for burn wounds are accelerating market growth[1][5].

Key Takeaways

• The global silver sulfadiazine market is expected to grow significantly, driven by the increasing demand for burn care and wound care products.
• North America and the Asia Pacific region are key markets due to high incidence rates and increasing demand.
• The market faces challenges such as side effects and increasing raw material costs.
• Cost-effectiveness studies suggest that alternative treatments like enclosed silver dressings may be more viable under certain conditions.
• The market is projected to reach $3,279.8 million by 2030, with a CAGR of 5.20%.

FAQs

What is silver sulfadiazine used for?

Silver sulfadiazine is primarily used for the treatment of second- and third-degree burns. It acts as a topical sulfonamide antibiotic to prevent bacterial and yeast growth on the skin[4].

Which regions are expected to drive the growth of the silver sulfadiazine market?

North America and the Asia Pacific region are expected to be the key drivers of the silver sulfadiazine market, due to the high incidence of burn cases and increasing demand for wound-care products[1].

What are the potential side effects of silver sulfadiazine?

Silver sulfadiazine can cause minor side effects such as nausea, loss of appetite, and dizziness, which may hinder demand for the product[1][3].

How does the cost of silver impact the silver sulfadiazine market?

The increasing price of silver, a key raw material for the production of silver sulfadiazine, is expected to impact production costs and subsequently restrain market growth[1][3].

What is the projected market size of the silver sulfadiazine market by 2030?

The global silver sulfadiazine market is projected to reach $3,279.8 million by 2030, growing at a CAGR of 5.20% from 2024 to 2030[5].

Sources

1. Coherent Market Insights: Silver Sulfadiazine Market - Share, Size and Industry Analysis.
2. PubMed: Cost-effectiveness comparison between topical silver sulfadiazine and enclosed silver dressings.
3. Coherent Market Insights: Silver Sulfadiazine Market Size and Trends.
4. DrugBank: Silver sulfadiazine: Uses, Interactions, Mechanism of Action.
5. IndustryARC: Silver Sulfadiazine Market - Forecast(2024 - 2030).