SULFAMETHOXAZOLE; TRIMETHOPRIM - Generic Drug Details

What are the generic sources for sulfamethoxazole; trimethoprim and what is the scope of freedom to operate?

Sulfamethoxazole; trimethoprim is the generic ingredient in twenty-two branded drugs marketed by Sun Pharm Inds Inc, Monarch Pharms, Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, Sun Pharm Industries, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Pharm Assoc, Usl Pharma, Alpharma Us Pharms, Naska, Novel Labs Inc, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Vista Pharms, Heritage Pharma Avet, Superpharm, and Shionogi, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

Forty-nine suppliers are listed for this compound.

Summary for SULFAMETHOXAZOLE; TRIMETHOPRIM

US Patents:	0
Tradenames:	22
Applicants:	37
NDAs:	66
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	151
Patent Applications:	5,909
DailyMed Link:	SULFAMETHOXAZOLE; TRIMETHOPRIM at DailyMed

Recent Clinical Trials for SULFAMETHOXAZOLE; TRIMETHOPRIM

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

Sponsor	Phase
Cairo University	Phase 4
Johns Hopkins University	Early Phase 1
Chang Gung Memorial Hospital	Phase 1/Phase 2

See all SULFAMETHOXAZOLE; TRIMETHOPRIM clinical trials

Pharmacology for SULFAMETHOXAZOLE; TRIMETHOPRIM

Drug Class	Dihydrofolate Reductase Inhibitor Antibacterial Sulfonamide Antimicrobial
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SULFAMETHOXAZOLE; TRIMETHOPRIM

J01EA	Trimethoprim and derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

J01EE	Combinations of sulfonamides and trimethoprim, incl. derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SULFAMETHOXAZOLE; TRIMETHOPRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Monarch Pharms	SEPTRA GRAPE	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017598-002	Feb 12, 1986		DISCN	No	No
Fosun Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole; trimethoprim	TABLET;ORAL	018598-004	May 19, 1982		DISCN	No	No
Usl Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	070204-001	Nov 8, 1985		DISCN	No	No
Watson Labs	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	018852-001	May 9, 1983		DISCN	No	No
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017598-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for SULFAMETHOXAZOLE; TRIMETHOPRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	RE28636
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982	3,551,564
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	4,209,513
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	RE28636
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982	RE28636

SULFAMETHOXAZOLE; TRIMETHOPRIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfamethoxazole and Trimethoprim

Introduction

Sulfamethoxazole and trimethoprim, commonly known by the brand name Bactrim among others, is a fixed-dose combination antibiotic used to treat a variety of bacterial infections. This article delves into the market dynamics and financial trajectory of this medication, highlighting key trends, drivers, and projections.

Market Size and Growth Projections

The sulfamethoxazole and trimethoprim market is anticipated to experience significant growth over the coming years. As of 2024, the market size is projected to be valued at USD 1.56 billion and is expected to rise to USD 2.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 3.76% during the forecast period[4].

Drivers of Market Growth

Several factors are driving the growth of the sulfamethoxazole and trimethoprim market:

Increasing Demand for Antibiotics

The rising incidence of bacterial infections, including urinary tract infections, MRSA skin infections, and respiratory tract infections, is driving the demand for effective antibiotics like sulfamethoxazole and trimethoprim[3].

Synergistic Effectiveness

The combination of sulfamethoxazole and trimethoprim has a synergistic effect, inhibiting successive steps in the folate synthesis pathway, which makes it more effective than when used separately. This synergy is a significant driver of its market demand[3].

Use in Immunocompromised Patients

The medication is crucial for treating and preventing infections in immunocompromised patients, such as those with HIV/AIDS, further boosting its market[3].

Market Segmentation

The market is segmented based on several factors:

By Region

The market is analyzed geographically across regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own consumption patterns, revenue, and growth rates[4].

By Application

The medication is used in various applications, including the treatment of urinary tract infections, skin infections, respiratory tract infections, and more. Understanding these segments helps in targeting specific markets and patient populations[4].

By Players

Key players such as Intas Pharmaceuticals Ltd., Macleods Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd., Cipla Ltd., and Cadila Healthcare Ltd. are profiled to understand their market ranks, competitive landscape, and strategies[4].

Market Dynamics: Drivers, Restraints, Opportunities, and Challenges

Drivers

• Increasing Antibiotic Resistance: The rise in antibiotic-resistant bacteria has led to a higher demand for effective combination antibiotics like sulfamethoxazole and trimethoprim.
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing countries, are increasing access to these medications.
• Government Initiatives: Public health initiatives and programs aimed at reducing infectious diseases also drive the market[1][4].

Restraints

• Adverse Events: While effective, sulfamethoxazole and trimethoprim can cause adverse events, leading to discontinuation in some cases, which can restrain market growth[5].
• Regulatory Hurdles: Strict regulatory environments and the need for continuous monitoring of side effects can slow down market expansion.

Opportunities

• Emerging Markets: Growing healthcare needs in emerging economies present significant opportunities for market expansion.
• Diversification of Applications: The potential to use sulfamethoxazole and trimethoprim in new therapeutic areas, such as salvage therapy for bone and joint infections, opens up new market avenues[5].

Challenges

• Competition from Generic Drugs: The availability of generic versions of sulfamethoxazole and trimethoprim can pose a challenge to branded products.
• Economic Fluctuations: Fluctuations in global economic conditions can affect the purchasing power of consumers and healthcare systems, impacting market growth[4].

Financial Performance and Projections

Revenue Growth

The market is expected to grow from USD 1.56 billion in 2024 to USD 2.1 billion by 2032, indicating a robust financial trajectory. This growth is driven by increasing demand, expanding healthcare infrastructure, and the effectiveness of the medication[4].

Competitive Landscape

The competitive landscape is characterized by key players focusing on innovative strategies, new product developments, and strategic collaborations. The market is fiercely competitive, with notable firms ranking high in terms of market share and revenue[4].

Regional Analysis

North America

North America, particularly the United States, is a significant market due to high healthcare spending and a large patient population. The region is expected to continue its strong growth trajectory[4].

Europe

Europe also represents a substantial market, with countries like Germany, France, and the UK contributing significantly to the regional revenue[4].

Asia-Pacific

The Asia-Pacific region, driven by countries like China, India, and Japan, is expected to see rapid growth due to increasing healthcare needs and improving economic conditions[4].

Conclusion

The sulfamethoxazole and trimethoprim market is poised for significant growth driven by its effectiveness, increasing demand, and expanding healthcare infrastructure. While there are challenges such as adverse events and regulatory hurdles, the opportunities in emerging markets and new therapeutic applications are substantial.

Key Takeaways

• The sulfamethoxazole and trimethoprim market is projected to grow from USD 1.56 billion in 2024 to USD 2.1 billion by 2032.
• The medication's synergistic effect and its use in treating various bacterial infections are key drivers of market growth.
• Emerging markets and new therapeutic applications present significant opportunities.
• Adverse events and regulatory challenges are restraints that need to be addressed.
• The competitive landscape is characterized by key players focusing on innovation and strategic collaborations.

FAQs

Q: What is the projected market size of sulfamethoxazole and trimethoprim by 2032? A: The market size is expected to rise to USD 2.1 billion by 2032[4].

Q: What are the primary drivers of the sulfamethoxazole and trimethoprim market? A: The primary drivers include increasing demand for antibiotics, the synergistic effectiveness of the combination, and its use in immunocompromised patients[3][4].

Q: Which regions are expected to see significant growth in the sulfamethoxazole and trimethoprim market? A: North America, Europe, and the Asia-Pacific region are expected to see significant growth[4].

Q: What are some of the challenges facing the sulfamethoxazole and trimethoprim market? A: Challenges include adverse events, regulatory hurdles, and competition from generic drugs[4][5].

Q: Who are some of the key players in the sulfamethoxazole and trimethoprim market? A: Key players include Intas Pharmaceuticals Ltd., Macleods Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd., Cipla Ltd., and Cadila Healthcare Ltd.[4].

Sources

1. Market Research Intellect: Sulfamethoxazole and Trimethoprim Tablets Market Size, Scope ...
2. PharmacyAngle: In-depth List Page | PharmacyAngle
3. Wikipedia: Trimethoprim/sulfamethoxazole
4. OpenPR: Sulfamethoxazole Trimethoprim Market Overall Study Report
5. PLOS ONE: Efficacy of cotrimoxazole (Sulfamethoxazole-Trimethoprim) as a salvage therapy for the treatment of bone and joint infections (BJIs)