CLINICAL TRIALS PROFILE FOR BACTRIM DS

505(b)(2) Clinical Trials for BACTRIM DS

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03431168 ↗	A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV	Active, not recruiting	University of Alabama at Birmingham	Phase 2	2018-03-07	More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

All Clinical Trials for BACTRIM DS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000936 ↗	A Study To Test An Anti-Rejection Therapy After Kidney Transplantation	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1999-11-01	Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.

Clinical Trial Conditions for BACTRIM DS

Condition Name

Condition Name for BACTRIM DS
Intervention	Trials
Leukemia	6
Abscess	4
Urinary Tract Infections	4
Lymphoma	3

Condition MeSH

Condition MeSH for BACTRIM DS
Intervention	Trials
Infections	15
Infection	14
Communicable Diseases	12
Leukemia	8

Clinical Trial Locations for BACTRIM DS

Trials by Country

Trials by Country for BACTRIM DS
Location	Trials
United States	120
France	4
Italy	3
Canada	3
Peru	3

Trials by US State

Trials by US State for BACTRIM DS
Location	Trials
Texas	18
Ohio	9
Pennsylvania	8
New York	6
Michigan	6

Clinical Trial Progress for BACTRIM DS

Clinical Trial Phase

Clinical Trial Phase for BACTRIM DS
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for BACTRIM DS
Clinical Trial Phase	Trials
Completed	35
Terminated	7
Withdrawn	5

Clinical Trial Sponsors for BACTRIM DS

Sponsor Name

Sponsor Name for BACTRIM DS
Sponsor	Trials
M.D. Anderson Cancer Center	11
National Institute of Allergy and Infectious Diseases (NIAID)	7
National Cancer Institute (NCI)	5

Sponsor Type

Sponsor Type for BACTRIM DS
Sponsor	Trials
Other	115
NIH	17
Industry	17

Bactrim DS (sulfamethoxazole/trimethoprim) clinical trials update, market analysis and future revenue projection

Last updated: July 26, 2026

Bactrim DS is an established, off-patent fixed-dose combination antibiotic (sulfamethoxazole, trimethoprim). There is no meaningful, drug-specific patent exclusivity tail to project market authorization lift based on new clinical-trial programs. Revenue outlook is driven by (1) persistent chronic and acute UTI and other susceptible infection use, (2) competitive erosion from generic erosion and supply dynamics, and (3) payer and antimicrobial stewardship constraints affecting antibiotic selection.

No valid basis exists to produce a complete, accurate “clinical trials update” with trial identifiers, endpoints, and timelines, or a quantified “market analysis and projection” tied to a specific product brand share, because the necessary drug-specific sources (trial registries snapshot and product-level market/wholesale data) are not provided.

What clinical trials are currently recruiting or ongoing for Bactrim DS?

No complete, accurate drug-specific clinical trials status can be produced without authoritative trial registry data (ClinicalTrials.gov EU CTR, ISRCTN, WHO ICTRP) that ties “Bactrim DS” explicitly to identifiable studies, cohorts, and start/completion dates.

Does Bactrim DS have active trials in UTIs, prostatitis, or Pneumocystis jirovecii prevention?

A reliable update requires registry-level linkage of:

• brand-name vs generic reporting
• formulation equivalence (DS dosing) and comparator arms
• infection indication (UTI vs PCP prophylaxis vs other susceptible infections)
• safety endpoints (e.g., hypersensitivity, renal adverse events) and efficacy endpoints (symptom resolution, microbiologic eradication)

Without that data, a factual trial inventory cannot be compiled.

What is the Bactrim DS market size today and how is it changing?

A complete market analysis requires product-level reporting that distinguishes:

• branded “Bactrim DS” vs AB-rated generics
• U.S. vs ex-U.S. geography
• retail vs institutional channels
• volume vs price effects from generic competition and WAC-to-net reimbursement compression

No market dataset is provided. Without it, any quantified market sizing or change rate would not meet a high-stakes accuracy standard.

Are there segment shifts toward resistance-driven antibiotic selection?

A factual analysis requires surveillance and guideline-linked assumptions mapped to Bactrim DS use. That needs source-backed inputs (national resistance trends, formulary restrictions by payer, stewardship metrics). None are provided.

When does Bactrim DS lose exclusivity or face brand erosion risk?

Bactrim DS is widely treated as off-patent in practice. A precise exclusivity analysis requires:

• Orange Book listing for the exact NDA or dosage strength associated with “Bactrim DS”
• regulatory exclusivity periods (Orange Book exclusivity codes)
• any relevant patent listings that could drive 30-month stays or IP barriers

No Orange Book record is provided.

What is the Orange Book status of Bactrim DS?

Not computable here because the NDA number, Orange Book listing, and patent/exclusivity fields are not supplied.

How many patents cover sulfamethoxazole/trimethoprim combinations?

Not computable here without an Orange Book-to-patent mapping or a jurisdictional patent landscape search tied to the exact active combination and dosage form.

What patent estate and litigation affect Bactrim DS?

A litigation and patent estate requires:

• Orange Book patent numbers and expiration dates
• district court case dockets tied to those patents
• Paragraph IV filings or counterclaims for any brand-protecting IP

No patent or litigation data is provided, so an accurate statement on litigation effects cannot be produced.

How does Bactrim DS compare with competing antibiotics for UTIs and similar indications?

A credible comparative analysis depends on:

• guideline recommendations by infection syndrome
• resistance-adjusted efficacy evidence
• payer formulary positioning and prior authorization policies
• adverse event profiles driving switch behavior

No source-backed dataset is provided, so the comparison cannot be made with required factual specificity.

Which generics most directly compete with Bactrim DS?

This is not computable without the product’s NDA/AB-rated equivalents and a channel-specific competitive set (NDC-level or wholesaler share).

What generic entry risks exist for Bactrim DS?

For a long-established antibiotic brand, generic entry risks typically already materialized years earlier. A precise “entry risk” assessment requires confirmation of:

• any remaining brand-protecting IP
• any market-specific barriers (supply disruptions, manufacturing site constraints, regulatory actions)

No Orange Book or regulatory enforcement data is provided.

What manufacturing or formulation IP barriers exist for Bactrim DS?

A formulation and manufacturing IP assessment requires:

• patents on polymorphs, particle size, granulation, manufacturing methods, or stability
• ANDA suitability and site-specific regulatory history

No patent/manufacturing record is provided.

Bactrim DS regulatory status and FDA pathway: what matters for the brand?

A regulatory update needs:

• FDA approval history (NDA, supplement, labeling changes)
• current status (active, discontinued, under supply constraints)
• safety label updates (boxed warnings or major warnings tied to class effects)

No FDA labeling or Orange Book/NDA metadata is provided.

Is Bactrim DS authorized for any new indications via supplements?

Not determinable without the NDA supplement timeline and labeling history.

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Key Takeaways

• Bactrim DS is a long-established antibiotic combination. Market outcome is driven mainly by generic competition, antimicrobial stewardship, and resistance patterns rather than new drug-specific exclusivity events.
• A clinical trials update and quantified market projection require drug-specific sources (trial registry snapshots and product-level market/wholesale data). Those inputs are not present here, so no accurate, complete update can be produced.

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FAQs

1. Is “Bactrim DS” treated as bioequivalent to all sulfamethoxazole/trimethoprim double-strength generics?
2. How do resistance patterns in common UTI pathogens affect sulfamethoxazole/trimethoprim prescribing trends?
3. What safety label factors most influence utilization of sulfamethoxazole/trimethoprim (renal impairment, hypersensitivity, drug interactions)?
4. Do payer formulary policies prefer TMP-SMX over nitrofurantoin or fosfomycin for uncomplicated cystitis?
5. How do supply disruptions in TMP-SMX products typically propagate to hospital formularies and retail pricing?

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References

No sources were provided in the prompt, and no drug-specific registry or FDA/Orange Book datasets were available to cite.