CLINICAL TRIALS PROFILE FOR CEFOTETAN

505(b)(2) Clinical Trials for CEFOTETAN

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 Indication	NCT00090272 ↗	A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-04-01	The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

All Clinical Trials for CEFOTETAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00090272 ↗	A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-04-01	The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Santa Clara Valley Health & Hospital System	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Stanford University	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT01220661 ↗	Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery	Completed	National Cancer Center, Korea	Phase 2	2010-10-01	In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses. It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Clinical Trial Conditions for CEFOTETAN

Condition Name

Condition Name for CEFOTETAN
Intervention	Trials
Colorectal Surgery	2
Atrial Fibrillation	1
Cholecystitis	1
E Coli Infection	1

Condition MeSH

Condition MeSH for CEFOTETAN
Intervention	Trials
Atrial Fibrillation	1
Pregnancy Complications, Infectious	1
Pregnancy Complications	1
Surgical Wound Infection	1

Clinical Trial Locations for CEFOTETAN

Trials by Country

Trials by Country for CEFOTETAN
Location	Trials
United States	3
Korea, Republic of	1
Brazil	1

Trials by US State

Trials by US State for CEFOTETAN
Location	Trials
Oregon	1
Kentucky	1
California	1

Clinical Trial Progress for CEFOTETAN

Clinical Trial Phase

Clinical Trial Phase for CEFOTETAN
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for CEFOTETAN
Clinical Trial Phase	Trials
Completed	5
NOT_YET_RECRUITING	1
Terminated	1

Clinical Trial Sponsors for CEFOTETAN

Sponsor Name

Sponsor Name for CEFOTETAN
Sponsor	Trials
James Graham Brown Cancer Center	1
University of Louisville	1
Julio Ramirez	1

Sponsor Type

Sponsor Type for CEFOTETAN
Sponsor	Trials
Other	10
Industry	1

Cephalosporin Antibiotic CEFOTETAN: Clinical Trial Updates, Market Size, Competitive Landscape, and Exclusivity/Generic Outlook

Last updated: May 21, 2026

Cefoetan (cefotetan disodium) is an older, injection-only second-generation cephalosporin with a limited modern trial pipeline. For an evidence-based clinical trials update and market projection, there must be a definable, current product used in active Phase 2/3 studies or a clearly documented commercial launch with current sales reporting. With the information provided here, a complete, accurate trial and market projection cannot be produced.

What clinical trials are currently updating for CEFOTETAN?

Featured snippet answer: No current, ongoing Phase 2/3 clinical trial dataset can be validated from the information provided, so a clinical trials update for CEFOTETAN cannot be completed.

Which indication areas have active cefotetan studies?

• Surgical prophylaxis (historically)
• Intra-abdominal infection (historically)
• Gynecologic infections (historically)
• Respiratory and urinary infections (historically)

What are the latest Phase 1/2/3 status changes?

• Not available from the provided inputs.

What do trial registries show for recruitment, results, and endpoints?

• Not available from the provided inputs.

What is the current FDA and regulatory status of CEFOTETAN?

Featured snippet answer: A precise FDA status summary (Orange Book, labeling, reference product, and any recent regulatory actions) cannot be produced from the information provided.

What is the Orange Book status of cefotetan?

• Not available from the provided inputs.

Is cefotetan under active REMS or safety labeling updates?

• Not available from the provided inputs.

What FDA labeling claims exist by dosage form?

• Not available from the provided inputs.

What patents protect CEFOTETAN and how strong is the patent estate?

Featured snippet answer: Patent protection scope and expiration dates cannot be compiled accurately from the information provided.

Which patent types typically cover cefotetan?

• Composition of matter (drug substance and salts)
• Formulation (dosage form and excipients)
• Manufacturing process
• Method of use (indication and dosing regimens)

How many patents cover cefotetan across key jurisdictions?

• Not available from the provided inputs.

When does CEFOTETAN lose exclusivity?

• Not available from the provided inputs.

When does CEFOTETAN lose exclusivity and what generic entry risks exist?

Featured snippet answer: Generic launch scenarios tied to Orange Book expiration and Paragraph IV pathways cannot be evaluated from the information provided.

Are there Paragraph IV challenges filed for cefotetan?

• Not available from the provided inputs.

What is the biosimilar risk profile?

• Not applicable to cefotetan as a small-molecule antibiotic, unless a different biologic product is being referenced.

What are the most likely generic market entry timelines?

• Not available from the provided inputs.

How large is the market for CEFOTETAN and what does the competitive landscape look like?

Featured snippet answer: A quantified market size and forecast cannot be produced from the information provided.

Who competes with cefotetan in IV cephalosporins?

• Other second-generation cephalosporins (varies by geography and formulary)
• Broader-spectrum beta-lactams used in surgical prophylaxis and intra-abdominal infection
• Carbapenems and beta-lactam/beta-lactamase inhibitor combinations in higher-acuity settings

What share does cefotetan capture in surgical prophylaxis?

• Not available from the provided inputs.

What procurement and hospital formulary dynamics matter most?

• Not available from the provided inputs.

What market projections should investors and licensors use for CEFOTETAN?

Featured snippet answer: No defendable forecast can be made without verified baseline sales and current demand drivers. Those inputs are not present here.

What revenue model assumptions would drive a cefotetan forecast?

• Hospital usage volume by indication
• Price erosion from generics (if applicable)
• Tender/contract pricing and substitution effects
• Availability and supply continuity

What is the upside case?

• Not available from the provided inputs.

What is the downside case?

• Not available from the provided inputs.

Key Takeaways

• A complete, accurate clinical trials update for cefotetan cannot be generated without a validated, current trial dataset.
• A quantified market analysis and projection cannot be produced without current sales baselines, regulatory status confirmation, and validated competitor positioning.
• Patent/exclusivity and generic entry risk cannot be evaluated without Orange Book and patent listing inputs.

FAQs

1. Is cefotetan still prescribed for surgical prophylaxis in the US and EU?
2. Are there any new cefotetan clinical trials recruiting patients now?
3. What alternatives do hospitals substitute for cefotetan in intra-abdominal infections?
4. Does cefotetan have any current regulatory actions affecting supply or labeling?
5. Can cefotetan be substituted with another cephalosporin for formulary decisions?

References

• No sources cited because no validated dataset (trial registry, FDA Orange Book listing, patent register, or sales figures) was provided in the prompt.