Last reviewed · How we verify
Hydrocodone bitartrate extended-release tablet
Hydrocodone bitartrate extended-release tablet is a Small molecule drug developed by Cephalon. It is currently in Phase 1 development. Also known as: CEP-33237.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Hydrocodone bitartrate extended-release tablet |
|---|---|
| Also known as | CEP-33237 |
| Sponsor | Cephalon |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets (PHASE3)
- Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate (PHASE1)
- Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain (PHASE3)
- Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time (PHASE3)
- Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time (PHASE3)
- A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine (PHASE4)
- Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children (PHASE2)
- Single Dose Pharmacokinetics of Egalet® Hydrocodone (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydrocodone bitartrate extended-release tablet CI brief — competitive landscape report
- Hydrocodone bitartrate extended-release tablet updates RSS · CI watch RSS
- Cephalon portfolio CI
Frequently asked questions about Hydrocodone bitartrate extended-release tablet
What is Hydrocodone bitartrate extended-release tablet?
Who makes Hydrocodone bitartrate extended-release tablet?
Is Hydrocodone bitartrate extended-release tablet also known as anything else?
What development phase is Hydrocodone bitartrate extended-release tablet in?
Related
- Manufacturer: Cephalon — full pipeline
- Also known as: CEP-33237
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing