BACTRIM Drug Patent Profile

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

Bactrim is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs.

The generic ingredient in BACTRIM is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bactrim

A generic version of BACTRIM was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25^th, 1986.

Summary for BACTRIM

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	65
Patent Applications:	4,532
Drug Prices:	Drug price information for BACTRIM
DailyMed Link:	BACTRIM at DailyMed

See drug prices for BACTRIM

Recent Clinical Trials for BACTRIM

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

Sponsor	Phase
Hospital Civil de Guadalajara	PHASE2
Ohio State University	PHASE4
Johns Hopkins University	Early Phase 1

See all BACTRIM clinical trials

Pharmacology for BACTRIM

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

US Patents and Regulatory Information for BACTRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for BACTRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982

International Patents for BACTRIM

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

Country	Patent Number	Title	Estimated Expiration
Canada	1003331	COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE
Belgium	698102
Switzerland	544053	Verfahren zur Herstellung von Sulfonamidderivaten (Injectable sulphonamide potentiator compns)
Germany	1617521
Denmark	117520

BACTRIM (sulfamethoxazole/trimethoprim) market dynamics and financial trajectory: pricing, demand drivers, and generic competition

Last updated: July 2, 2026

BACTRIM (sulfamethoxazole/trimethoprim; SMX/TMP) is a long-established, heavily genericized antibiotic with limited patent tail risk and a business profile dominated by generic pricing, tender and reimbursement dynamics, and periodic safety/label updates that affect utilization rather than exclusivity. Financial performance tracks broadly to (1) volume swings tied to respiratory and urinary tract infection incidence and guideline adherence, (2) payer pressure toward lowest-net-cost generics, and (3) supply-chain or manufacturing constraints in generic SMX/TMP. The competitive landscape is structurally low margin, with marketing and contract positioning often outweighing brand differentiation.

Why does BACTRIM’s market share track generics pricing and reimbursement more than brand marketing?

BACTRIM is not a protected blockbuster in most markets today. The operating reality is that BACTRIM’s U.S. and ex-U.S. economics are set by generic entry and payer formularies that favor cost-minimizing alternatives.

What structural forces drive BACTRIM unit demand

Key demand drivers for SMX/TMP combinations include:

• Indication mix across uncomplicated urinary tract infections (UTIs), skin/soft tissue infections in select settings, and certain respiratory infections depending on local resistance patterns.
• Stewardship cycles: broad antibiotic utilization can tighten or loosen based on resistance surveillance and public health guidance.
• Seasonal infection patterns that affect UTI and respiratory infection volume.

What structural forces drive BACTRIM net price and revenue

• Generic substitution: SMX/TMP generics typically win on price and interchangeability.
• Payer contracting: pharmacy benefit managers and hospital formularies often use covered drug lists and price benchmarks.
• Tender procurement: for hospital antibiotic procurement, the cost-per-course and supply reliability dominate.

How have BACTRIM’s revenues and margins typically evolved since heavy generic entry?

Featured snippet answer: BACTRIM’s financial trajectory post-genericization is characterized by declining brand-revenue share, compressed gross margins, and stabilization mainly through remaining brand or channel positions, where present.

Commercial pattern seen in genericized antibiotic classes

Across older antibiotic brands, the common trajectory is:

• Brand revenue share falls as formularies shift to the lowest-cost multisource options.
• Remaining brand sales become concentrated in specific channels, prescribers, or contract situations.
• Marketing spend becomes less scalable versus generic price competition.
• Profitability depends on (a) remaining differentiated presentations or pack sizes, (b) contract pricing, and (c) operational efficiencies.

Where BACTRIM can still matter financially

• Niche loyalty in certain prescriber segments where SMX/TMP is clinically preferred.
• Export markets or distribution networks where specific brand SKUs remain stocked longer.
• Institutional markets where procurement cycles lag when supply disruptions occur.

When does BACTRIM lose exclusivity in the U.S. and EU, and how does that shape financial trajectory?

Featured snippet answer: BACTRIM’s market is dominated by long-expired small-molecule exclusivities in the U.S. and EU, so the financial trajectory is governed less by patent timing and more by generic pricing and competitive capacity.

U.S. exclusivity and patent regime impact

For SMX/TMP combination products, the primary commercial effect historically comes from:

• Expiration of composition-of-matter and early formulation patents decades ago.
• Multisource approval and substitution that quickly erodes any remaining brand positioning.
• Ongoing label or manufacturing-related regulatory changes that affect utilization, not exclusivity.

EU commercialization dynamics

EU markets tend to show similar patterns:

• Early generics dominate when patent protection ends.
• Variability comes from reimbursement rules, tendering, and local resistance patterns that drive which antibiotic combination is selected.

What filings, Orange Book status, and FDA listing patterns matter for BACTRIM competitors?

Featured snippet answer: BACTRIM’s practical regulatory relevance for market dynamics is the volume of FDA-approved SMX/TMP ANDA products and how quickly they maintain supply through manufacturing capacity rather than any ongoing branded exclusivity.

How Orange Book listings shape competitive intensity

When multiple ANDA holders exist for the same strength/dosage form, the outcome is:

• Rapid competitive price compression.
• Frequent tender price changes.
• Less ability for any single supplier to maintain pricing absent supply constraints.

What FDA events can move sales even in a fully generic category

• Safety labeling changes that influence prescriber comfort and patient selection.
• Shortages or distribution interruptions that force temporary formulary exceptions or alternate selection patterns.

Which indication segments most influence BACTRIM revenue exposure over time?

Featured snippet answer: Revenue sensitivity is highest in UTI and skin/soft tissue infection utilization and lower in episodic or guideline-driven niche settings.

UTIs

SMX/TMP is commonly considered where resistance and patient factors align. Revenue exposure moves with:

• Local antibiograms.
• Stewardship restrictions that shift UTI empiricism toward other agents in high-resistance settings.
• Public and inpatient antibiotic pathway changes.

Skin/soft tissue infections

Utilization depends on MRSA prevalence and local guideline selection. Changes in resistance epidemiology drive selection more than brand identity.

Respiratory infections

SMX/TMP has narrower contemporary roles versus guideline-preferred classes, so revenue changes can be smaller but still swing with stewardship and resistance.

How does antibiotic stewardship change BACTRIM demand and pricing?

Featured snippet answer: Stewardship affects the share of patients receiving SMX/TMP and can shift volume quickly, but it rarely prevents generic price erosion once multiple suppliers exist.

Mechanisms of impact

• Prior authorization or guideline-driven restrictions can reduce empiric use.
• De-escalation practices can increase SMX/TMP use when susceptibility supports it.
• Resistance-guided prescribing changes the mix of antibiotic classes used.

What generic entry risks exist for BACTRIM, given the category is already crowded?

Featured snippet answer: In SMX/TMP, new generic entry risk is low in the sense of “patent entry,” but operational risk is high through manufacturing capacity, supply shortages, and distribution failures.

Where competition can intensify even without exclusivity

• Capacity expansion by generic manufacturers can increase supply and push prices down.
• Packaging/presentation expansions can win shelf placement or contract inclusion.
• Regulatory quality events can temporarily remove suppliers, allowing remaining players to price higher.

How do shortages and supply disruptions affect BACTRIM’s financial performance?

Featured snippet answer: In a low-margin generic market, shortages typically cause short-term price relief and volume gains for available suppliers, then reverse as supply returns.

Shortage transmission channels

• Hospital allocation systems shift demand to in-stock suppliers.
• Distributor fill rates influence which SKUs remain on formularies.
• Competitors with stable supply can gain share during shortages.

How does BACTRIM compare with competing antibiotics on market dynamics?

Featured snippet answer: BACTRIM competes in a crowded environment where cephalosporins, nitrofurantoin, fluoroquinolones, fosfomycin, and newer beta-lactam/beta-lactamase inhibitor options often drive share in UTIs and complicated infections based on resistance and payer rules.

Market-structure comparison

• BACTRIM: low differentiation, high substitution, pricing pressure.
• Alternatives: higher differentiation or payer preference in certain pathways can displace SMX/TMP even if pricing is not lower.

What are the key commercial levers for BACTRIM suppliers during price compression?

Featured snippet answer: Supplier profitability tends to depend on contracting efficiency, manufacturing yield, and logistics rather than marketing.

Most important levers

• Contracting discipline with PBMs, GPOs, and hospital formularies.
• Scale economics and low-cost manufacturing of API and formulation.
• Line efficiencies and quality throughput to avoid batch rejections.
• SKU strategy (strengths, tablet/suspension, package size) aligned to billing and procurement habits.

Key timeline: how the market typically evolves for an old antibiotic combination like BACTRIM

Because SMX/TMP combination products are long genericized, the “timeline” is primarily operational and policy-driven rather than patent-driven:

1. Generic consolidation phase: multiple ANDA holders establish supply and trigger price compression.
2. Contract stabilization: formulary inclusion becomes a function of net price, rebate terms, and supply reliability.
3. Policy/label-driven utilization shifts: stewardship or safety labeling alters share between antibiotic classes.
4. Capacity shocks: manufacturing disruptions cause temporary price changes and share shifts.
5. Ongoing churn: suppliers rotate based on cost competitiveness and operational performance.

Key Takeaways

• BACTRIM’s financial trajectory is dominated by generic competition, contract tendering, and payer reimbursement, not by exclusivity or patent-driven periods.
• Demand is sensitive to antibiotic stewardship and local resistance patterns, especially in UTI and skin/soft tissue infection pathways.
• Price and margins are structurally compressed; short-term performance improves mainly during supply constraints, then normalizes as capacity returns.
• Market share is typically a function of net pricing, formulary placement, and manufacturing reliability rather than brand differentiation.

FAQs

1. How do hospital antibiotic stewardship protocols typically affect SMX/TMP (BACTRIM) use for UTIs?
2. What role do local resistance and antibiograms play in sustaining BACTRIM prescribing?
3. How do generic SMX/TMP suppliers compete in contracting with PBMs and GPOs?
4. What happens to BACTRIM pricing during generic supply shortages?
5. Which alternative antibiotics most commonly displace BACTRIM in outpatient UTI treatment pathways?

References (APA)

1. FDA. (n.d.). Drug shortages. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA. (n.d.). Drug approvals and databases. U.S. Food and Drug Administration.
4. IDSA. (n.d.). Infectious Diseases Society of America guidance and recommendations (UTI and stewardship-related resources).

DrugChatter Q&A for BACTRIM

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Sigla que se transformo en bactrim?
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