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Carac (5-fu)
Carac, a 5-fluorouracil topical cream marketed by Spectrum Pharms, holds a niche position in the treatment of actinic keratosis. Its key strength lies in its mechanism of action, which effectively interferes with DNA synthesis, hindering cancer cell replication. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | 5-fu |
|---|---|
| Sponsor | Spectrum Pharms |
| Drug class | Nucleoside Metabolic Inhibitor |
| Target | Aromatase |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1962 |
Approved indications
- Actinic keratosis
- Adenocarcinoma of pancreas
- Malignant tumor of colon
- Malignant tumor of stomach
- Metastasis from malignant tumor of colon
- Metastatic Breast Carcinoma
- Small intestine cancer
- Superficial basal cell carcinoma
Common side effects
Drug interactions
- CYP2C9 Substrates
- warfarin
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (PHASE2)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Carac CI brief — competitive landscape report
- Carac updates RSS · CI watch RSS
- Spectrum Pharms portfolio CI