SULFACETAMIDE SODIUM - Generic Drug Details

What are the generic drug sources for sulfacetamide sodium and what is the scope of freedom to operate?

Sulfacetamide sodium is the generic ingredient in seventeen branded drugs marketed by Bausch, Fougera Pharms, Padagis Us, Taro, Allergan, Alcon, Schering, Pharmafair, Miza Pharms Usa, Epic Pharma Llc, Sola Barnes Hind, Novartis, Optopics, Alcon Pharms Ltd, Bausch And Lomb, Sandoz, and Sciegen Pharms Inc, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for sulfacetamide sodium. Thirteen suppliers are listed for this compound.

Summary for SULFACETAMIDE SODIUM

US Patents:	0
Tradenames:	17
Applicants:	17
NDAs:	30
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	2
Patent Applications:	46
What excipients (inactive ingredients) are in SULFACETAMIDE SODIUM?	SULFACETAMIDE SODIUM excipients list
DailyMed Link:	SULFACETAMIDE SODIUM at DailyMed

Recent Clinical Trials for SULFACETAMIDE SODIUM

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1/Phase 2
Sidney Kimmel Cancer Center at Thomas Jefferson University	N/A

See all SULFACETAMIDE SODIUM clinical trials

Pharmacology for SULFACETAMIDE SODIUM

Drug Class

Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for SULFACETAMIDE SODIUM

Anti-Infective Agents, Local

Anti-Infective Agents, Urinary

Anatomical Therapeutic Chemical (ATC) Classes for SULFACETAMIDE SODIUM

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

S01AB	Sulfonamides
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for SULFACETAMIDE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	SODIUM SULAMYD	sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	005963-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Miza Pharms Usa	OCUSULF-30	sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	080660-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Taro	SULFACETAMIDE SODIUM	sulfacetamide sodium	LOTION;TOPICAL	078668-001	May 20, 2009	AB	RX	No	No
Sola Barnes Hind	SODIUM SULFACETAMIDE	sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	084145-001	Approved Prior to Jan 1, 1982		DISCN	No	No

SULFACETAMIDE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfacetamide Sodium

Introduction to Sulfacetamide Sodium

Sulfacetamide Sodium is a versatile and widely used antibiotic that has been a staple in the pharmaceutical industry since its first approval in December 1996 in the United States. It is a small molecule drug that targets the enzyme dihydropteroate synthase (DHPS), essential for bacterial and parasitic folate synthesis[4].

Market Size and Growth

The global market for Sulfacetamide Sodium has shown significant growth over the years. As of recent reports, the Sulfacetamide Sodium API market is projected to expand substantially, with estimates suggesting it will reach a value of USD xx billion by 2031, up from its value in 2023[1].

Therapeutic Applications

Sulfacetamide Sodium is indicated for a broad range of therapeutic applications, including:

• Ophthalmic Infections: It is commonly used in ophthalmic formulations for the treatment of conjunctivitis, trachoma, and other superficial ocular infections caused by susceptible microorganisms[2][4].
• Dermatological Conditions: It is used in dermatological formulations for the treatment of dermatitis, including seborrheic dermatitis, and acne vulgaris. The drug reduces inflammation and controls bacterial growth on the skin[4].
• Other Indications: It is also effective in treating various infectious diseases, skin and musculoskeletal diseases, and urogenital diseases[4].

Mechanism of Action

Sulfacetamide Sodium works by inhibiting the growth of bacteria that cause infections. It targets the DHPS enzyme, which is crucial for the synthesis of folate in bacteria and parasites. This mechanism makes it effective against a wide range of pathogens, including those responsible for malaria[4].

Safety and Efficacy

Since its approval, Sulfacetamide Sodium has established a strong track record of safety and efficacy. However, like all medications, it comes with potential side effects and warnings. Common reactions include local irritation, stinging, and burning, while less common but more severe reactions can include allergic reactions, Stevens-Johnson syndrome, and other blood dyscrasias[2].

Regulatory Landscape

Sulfacetamide Sodium has been approved globally, with significant regulatory milestones achieved in countries like the United States and China. The drug's long history of use and approval in different countries further supports its reliability and effectiveness[4].

Competitive Landscape

The competitive landscape for DHPS inhibitors, including Sulfacetamide Sodium, is characterized by multiple companies with varying levels of R&D progress. Key players such as AbbVie, Inc., Novartis AG, and Sun Pharmaceutical Industries Ltd. are actively involved in the development of drugs targeting the DHPS enzyme[4].

Research and Development

As of recent data, there are 37 DHPS drugs worldwide, covering 65 indications and involving 304 clinical trials. This indicates a robust R&D pipeline, with small molecule drugs being the most rapidly progressing type. China and the United States are at the forefront of these developments, with a high number of drugs in the approved phase[4].

Market Segments and Sub-Segments

The global Sulfacetamide Sodium market can be segmented based on various factors, including:

• Therapeutic Areas: Ophthalmic, dermatological, and other infectious diseases.
• Formulations: Ophthalmic solutions, creams, and other topical preparations.
• Geography: North America, Europe, Asia-Pacific, and other regions.
• End Users: Hospitals, clinics, and retail pharmacies[5].

Financial Performance

The financial trajectory of Sulfacetamide Sodium is influenced by several factors, including market demand, competition, and regulatory approvals. The drug's broad therapeutic applications and established safety profile contribute to its steady market performance. Here are some key financial indicators:

• Revenue Growth: The market is expected to grow significantly, driven by increasing demand for effective treatments for bacterial and parasitic infections.
• Market Share: Companies like AbbVie, Novartis, and Sun Pharmaceutical are likely to maintain a strong market share due to their extensive R&D efforts and global presence.
• Cost and Pricing: The cost of production and pricing strategies of pharmaceutical companies play a crucial role in determining the financial performance of Sulfacetamide Sodium. Generic versions of the drug can impact pricing dynamics[1][5].

Challenges and Opportunities

Challenges

• Resistance and Side Effects: The development of bacterial resistance to sulfonamides and potential side effects are significant challenges. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs[2].
• Regulatory Hurdles: Navigating complex regulatory environments in different countries can be challenging.

Opportunities

• Expanding Therapeutic Areas: The versatility of Sulfacetamide Sodium offers opportunities for expansion into new therapeutic areas, such as antiparasitic treatments.
• Emerging Markets: Growing healthcare needs in emerging markets present opportunities for increased market penetration and revenue growth.

Key Takeaways

• Broad Therapeutic Applications: Sulfacetamide Sodium is used in various therapeutic areas, including ophthalmic, dermatological, and other infectious diseases.
• Established Safety and Efficacy: The drug has a strong track record of safety and efficacy since its approval in 1996.
• Robust R&D Pipeline: The DHPS inhibitor market, including Sulfacetamide Sodium, has a robust R&D pipeline with multiple clinical trials and approvals.
• Financial Growth: The market is expected to grow significantly, driven by increasing demand and expanding therapeutic applications.

FAQs

Q1: What is Sulfacetamide Sodium used for?

Sulfacetamide Sodium is used for the treatment of various infections, including conjunctivitis, trachoma, seborrheic dermatitis, and acne vulgaris. It targets the DHPS enzyme to inhibit bacterial and parasitic growth.

Q2: How does Sulfacetamide Sodium work?

Sulfacetamide Sodium works by inhibiting the DHPS enzyme, which is essential for the synthesis of folate in bacteria and parasites, thereby disrupting their growth and replication.

Q3: What are the common side effects of Sulfacetamide Sodium?

Common side effects include local irritation, stinging, and burning. Less common but more severe reactions can include allergic reactions, Stevens-Johnson syndrome, and other blood dyscrasias.

Q4: Is Sulfacetamide Sodium safe for infants?

Safety and effectiveness in children below the age of two months have not been established. Additionally, systematically administered sulfonamides can produce kernicterus in infants of lactating women[2].

Q5: What is the competitive landscape like for Sulfacetamide Sodium?

The competitive landscape is characterized by multiple companies with varying levels of R&D progress. Key players include AbbVie, Inc., Novartis AG, and Sun Pharmaceutical Industries Ltd.[4].

Sources

1. Market Research Intellect: Sulfacetamide Sodium API Market Size, Scope And Forecast Report.
2. DailyMed: SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%.
3. Cognitive Market Research: Global Sulfacetamide Sodium CAS 127 56 0 Market Report 2024.
4. Patsnap Synapse: A Comprehensive Review of Sulfacetamide sodium's R&D Innovations.
5. Cognitive Market Research: Sulfacetamide Sodium Market Report 2024 (Global Edition).