CLINICAL TRIALS PROFILE FOR DURICEF

All Clinical Trials for DURICEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00834275 ↗	Cefadroxil 500 mg Capsules Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fasting conditions.
NCT00835081 ↗	Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Plastic Surgery Educational Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	The Plastic Surgery Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Stony Brook University	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT02446496 ↗	A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects	Completed	GlaxoSmithKline	Phase 4	2014-03-31	This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &Chem .Ind. Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a trademark of Sandoz.

Clinical Trial Conditions for DURICEF

Condition Name

Condition Name for DURICEF
Intervention	Trials
Healthy	3
Breast Implantation	1
Pyomyositis	1
Chronic Kidney Diseases	1

Condition MeSH

Condition MeSH for DURICEF
Intervention	Trials
Autoimmune Diseases	1
Pyomyositis	1
Osteomyelitis	1
Arthritis, Infectious	1

Clinical Trial Locations for DURICEF

Trials by Country

Trials by Country for DURICEF
Location	Trials
United States	7
Egypt	2
Canada	2

Trials by US State

Trials by US State for DURICEF
Location	Trials
Texas	2
West Virginia	1
Iowa	1
Arkansas	1
Colorado	1

Clinical Trial Progress for DURICEF

Clinical Trial Phase

Clinical Trial Phase for DURICEF
Clinical Trial Phase	Trials
Phase 4	3
Phase 1	4

Clinical Trial Status

Clinical Trial Status for DURICEF
Clinical Trial Phase	Trials
Completed	6
Recruiting	1

Clinical Trial Sponsors for DURICEF

Sponsor Name

Sponsor Name for DURICEF
Sponsor	Trials
GlaxoSmithKline	2
Teva Pharmaceuticals USA	2
Stony Brook University	1

Sponsor Type

Sponsor Type for DURICEF
Sponsor	Trials
Other	5
Industry	5

Last updated: April 24, 2026

DURICEF (cefadroxil): What’s in the clinical-trial record, and what does the market projection imply?

1) What is DURICEF and how is it positioned therapeutically?

DURICEF is the brand name for cefadroxil, an oral first-generation cephalosporin antibiotic. It is used for bacterial infections susceptible to cefadroxil, and it competes primarily in the generics-heavy oral antibiotic segment.

Key product reality

• Cefadroxil is off-patent in major markets; DURICEF branding does not anchor exclusivity in the way modern small-molecule or biologic pipelines do.
• Clinical evidence base for cefadroxil is largely derived from earlier-era trials and comparative studies rather than late-stage, label-expansion programs run under current modern regulatory frameworks.

---

2) What does the clinical-trials update show?

No current, active, late-stage (Phase 3 or Phase 4) interventional program tied specifically to the brand DURICEF is identifiable from the available public record in the form of a current sponsor-led “update package” (trial identifiers, enrollment status, top-line results, or protocol amendments) suitable for a time-stamped clinical update.

What is instead visible in standard public registries and labeling histories is a mature evidence base for cefadroxil with ongoing data mostly related to:

• Prescribing practice and pharmacovigilance
• Comparative efficacy in older literature
• Microbiologic susceptibility surveillance and post-marketing observation, typically not framed as new “DURICEF clinical trials” with brand-level differentiation.

Implication for an R&D or investment view

• The “clinical update” for DURICEF is best treated as label maintenance and safety monitoring rather than a pipeline-driven growth story.

---

3) How does the market work for cefadroxil/DURICEF?

Market structure

• Oral first-generation cephalosporins are commoditized.
• Generic penetration drives pricing and volume volatility.
• Competitive intensity is determined by:
  • Price elasticity in antibiotics
  • Formulary preferences and payer step edits
  • Local antimicrobial stewardship rules
  • Shifts toward narrower or better-tolerated alternatives in some indications

Where DURICEF competes Typical use cases for cefadroxil include susceptible infections where an oral beta-lactam is appropriate. In practice, cefadroxil competes with:

• Other oral cephalosporins (generation- and spectrum-dependent)
• Oral beta-lactam alternatives (penicillins, amoxicillin-clavulanate where appropriate)
• Macrolides or other antibiotic classes when resistance patterns and guideline positioning favor them

---

4) What is the projected market path?

A forward projection for DURICEF in 2025-2029 is constrained by the same factors shaping other off-patent oral antibiotics:

• Generic price compression
• Stewardship-driven utilization caps
• Substitution to competing generics or different classes
• No brand-level exclusivity unless a separate, proprietary formulation or new dosing regimen is secured (not evidenced in the available record)

Projection framing (directional, not product-cycle-resetting)

• Base case: stable-to-declining branded share as generics dominate.
• Downside: faster volume decline if payer formularies reduce use or if local resistance patterns reduce the relative attractiveness of cefadroxil.
• Upside: limited brand recovery only through niche regional contracting or temporary payer switches, not via durable exclusivity.

Because cefadroxil is a mature, generic antibiotic, the realistic investment thesis is tied to:

• Contracted channel strength
• Cost position for generics-derived supply chains
• Compliance with stewardship and formulary policies

---

5) What can an operator do with this analysis?

Commercial actions that matter for an off-patent antibiotic

• Formulary and payer retention: focus on contract duration, prior authorization patterns, and stewardship-linked criteria.
• Channel strategy: target distributor and wholesaler terms that protect net price despite reimbursement pressure.
• SKU economics: manage working capital and SKU-specific pricing, since margin is the main variable.
• Adherence to susceptibility guidance: keep marketing and sales aligned with clinical pathways that prescribers follow in stewardship settings.

R&D actions that matter for the label stage

• If no modern Phase 3 program is planned, the “R&D” is primarily:
  • formulation life-cycle management (bioequivalence, stability, packaging)
  • pharmacovigilance operations
  • updated labeling alignment with stewardship and resistance surveillance

---

Key Takeaways

• DURICEF (cefadroxil) is an off-patent, commoditized oral antibiotic with an established clinical evidence base rather than a current late-stage trial engine.
• A “clinical trials update” at the brand level is not supported by a current, sponsor-anchored Phase 3/4 record that would drive a new efficacy or safety narrative.
• Market projection is dominated by generic price compression, stewardship utilization controls, and therapeutic substitution, making durable growth unlikely without a separate exclusivity path.

---

FAQs

1) Is DURICEF backed by new Phase 3 data?
No current, brand-level Phase 3/4 interventional trial record suitable for a time-stamped “update” emerges from the available public information.

2) What drives DURICEF sales when patents are not the lever?
Net price after rebates, formulary placement, payer policy, and channel contracting in a generic-dominant antibiotic class.

3) How does antimicrobial stewardship affect cefadroxil demand?
It can reduce utilization through guideline alignment, restriction policies, and substitution toward alternatives based on resistance and local antibiograms.

4) What is the most realistic growth mechanism for DURICEF?
Near-term channel and payer contracting wins, or a differentiated formulation strategy, rather than label-expansion exclusivity.

5) Does cefadroxil have a robust safety record?
Yes, it has a long post-marketing history typical of first-generation cephalosporins, with ongoing pharmacovigilance rather than new late-stage trials.

---

References

[1] U.S. Food and Drug Administration. Drug Approval Reports and Product Labeling for DURICEF (cefadroxil). FDA Access Data.
[2] DailyMed. DURICEF (cefadroxil) capsules/prescribing information. National Library of Medicine.
[3] ClinicalTrials.gov. Search results for cefadroxil and DURICEF; interventional studies and trial registry entries. U.S. National Library of Medicine.