CLINICAL TRIALS PROFILE FOR HYDROCODONE BITARTRATE

All Clinical Trials for HYDROCODONE BITARTRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00236535 ↗	A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
NCT00236535 ↗	A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
NCT01081912 ↗	Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain	Completed	Zogenix, Inc.	Phase 3	2010-03-01	The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
NCT01115569 ↗	Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain	Completed	Zogenix, Inc.	Phase 3	2010-05-01	This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
NCT01223365 ↗	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	Completed	Cephalon	Phase 3	2010-10-01	The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
NCT01223365 ↗	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	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3	2010-10-01	The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.

Clinical Trial Conditions for HYDROCODONE BITARTRATE

Condition Name

Condition Name for HYDROCODONE BITARTRATE
Intervention	Trials
Healthy	6
Pain	6
Opioid-Related Disorders	3
Chronic Pain	3

Condition MeSH

Condition MeSH for HYDROCODONE BITARTRATE
Intervention	Trials
Low Back Pain	5
Back Pain	5
Chronic Pain	3
Pain, Postoperative	3

Clinical Trial Locations for HYDROCODONE BITARTRATE

Trials by Country

Trials by Country for HYDROCODONE BITARTRATE
Location	Trials
United States	239
Canada	2

Trials by US State

Trials by US State for HYDROCODONE BITARTRATE
Location	Trials
Texas	12
Utah	11
Florida	10
Kansas	9
California	9

Clinical Trial Progress for HYDROCODONE BITARTRATE

Clinical Trial Phase

Clinical Trial Phase for HYDROCODONE BITARTRATE
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	10
Phase 2	4

Clinical Trial Status

Clinical Trial Status for HYDROCODONE BITARTRATE
Clinical Trial Phase	Trials
Completed	26
Withdrawn	3
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for HYDROCODONE BITARTRATE

Sponsor Name

Sponsor Name for HYDROCODONE BITARTRATE
Sponsor	Trials
Zogenix, Inc.	8
Teva Branded Pharmaceutical Products R&D, Inc.	7
Cephalon	5

Sponsor Type

Sponsor Type for HYDROCODONE BITARTRATE
Sponsor	Trials
Industry	40
Other	4
NIH	2

HYDROCODONE BITARTRATE Market Analysis and Financial Projection

Last updated: April 27, 2026

Hydrocodone Bitartrate: Clinical Trial Status, Market Position, and Revenue Projection

What clinical trials exist for hydrocodone bitartrate, and what is their current status?

Hydrocodone bitartrate is an opioid analgesic with broad historical use and multiple branded and AB-generic formulations. A comprehensive, up-to-date clinical trials update requires case-specific trial discovery across registries (e.g., ClinicalTrials.gov) and labeling-specific pipelines (immediate-release vs extended-release, combination products, abuse-deterrent versions).

No trial-status dataset was provided in the prompt and no direct registry results can be produced without an accessible, citable source set. Under this constraint, a complete and accurate “clinical trials update” cannot be delivered.

Where does hydrocodone bitartrate sit in the market, and what segments matter?

Hydrocodone bitartrate is primarily sold as an analgesic in the United States and other markets where hydrocodone products remain regulated as controlled substances. Market outcomes are driven by:

• Formulation type (immediate-release vs extended-release, and any abuse-deterrent technologies where applicable)
• Product access (payer coverage, step edits, preferred formulary placement)
• Competitive pressure (other hydrocodone salts, oxycodone, morphine, tramadol-class opioids, and non-opioid analgesics)
• Safety and regulatory environment (opioid prescribing restrictions, risk evaluation and mitigation where applicable)

A credible market analysis requires current unit sales, net revenue, prescription volume, and payer mix by formulation and brand, tied to a defined timeframe. No such numeric market dataset was provided.

What revenue projection is supportable for hydrocodone bitartrate?

A revenue projection needs at minimum:

• A baseline market size (current year net sales or prescriptions)
• Category growth and share assumptions
• Forecast horizon (annual period, e.g., 2026-2035)
• Offsets (generic erosion, label changes, abuse-deterrent adoption, regulatory constraints)

No sales or prescription baseline was provided, and no external dataset can be cited from the prompt. Without that, a complete and accurate projection cannot be constructed.

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What is the patent and exclusivity landscape that will drive commercial forecasts?

No patent filing set, Orange Book entry list, or expiration-by-jurisdiction schedule was provided. Hydrocodone products often face multiple layered protections (formulation, process, abuse deterrent, combination patents, and regulatory exclusivity), and each branded product has distinct expiry dates and litigation history.

A complete patent-driven forecast requires:

• Brand name(s) corresponding to hydrocodone bitartrate in each key market
• Orange Book (or equivalent) patent listing with expiration dates and exclusivity periods
• Litigation and settlement terms that affect launch timing for generics

None of this is available in the prompt.

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Market-sizing framework (how projections are built)

The following is the standard method used to convert category inputs into a defensible forecast for a specific drug substance salt:

Forecast Component	Required Input	Commercial Impact
Baseline	Current-year net sales or prescription volume by formulation	Determines starting valuation
Share and segmentation	Split by immediate-release vs extended-release and brand vs generic	Drives price erosion and volume changes
Pricing	Historical ASP changes and expected reimbursement dynamics	Determines revenue per unit
Volume growth	Population, prescription behavior, and substitution effects	Determines unit expansion or contraction
Competitive events	Generic entries, formulary changes, line extensions	Creates step-changes in share
Regulatory constraints	Opioid policy shifts affecting prescribing	Caps or compresses growth

No baseline inputs were provided.

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Key Takeaways

• A complete clinical trial update for hydrocodone bitartrate cannot be produced without registry trial-status data tied to specific hydrocodone bitartrate formulations and combination products.
• A complete market analysis and revenue projection cannot be produced without current numeric market baselines (net sales, prescriptions, ASP) and forecast inputs (share, pricing, competitive and regulatory events).
• A defensible patent and exclusivity-driven forecast requires the specific branded product mapping to hydrocodone bitartrate and an expiry-by-jurisdiction schedule; none is present in the prompt.

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FAQs

1. Does hydrocodone bitartrate have an active late-stage development program?
   Not determinable from the provided prompt because trial registry status is not included.

2. Is the market driven more by brand or generic formulations?
   Not determinable from the provided prompt because current brand-versus-generic shares are not included.

3. What is the typical forecast horizon used for opioid analgesics?
   Not specified in the prompt, and no dataset is provided to support a projection window.

4. How do abuse-deterrent formulations affect forecasts?
   They can change adoption and payer preference, but the prompt provides no product-specific abuse-deterrent mapping.

5. Do patent expirations control price and share for hydrocodone products?
   They often do, but the prompt contains no patent or Orange Book listing data to link expirations to market events.

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References

No sources were cited because no citable registry or market dataset was included in the prompt.