CLINICAL TRIALS PROFILE FOR PERCOCET

505(b)(2) Clinical Trials for PERCOCET

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
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

All Clinical Trials for PERCOCET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00444808 ↗	Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs	Terminated	Université de Montréal	Phase 4	2007-02-01	This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up. Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Rabin Medical Center	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Sheba Medical Center	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Tel Aviv University	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.

Clinical Trial Conditions for PERCOCET

Condition Name

Condition Name for PERCOCET
Intervention	Trials
Pain	11
Postoperative Pain	4
Pain, Postoperative	3
Shoulder Pain	2

Condition MeSH

Condition MeSH for PERCOCET
Intervention	Trials
Pain, Postoperative	12
Fractures, Bone	3
Osteoarthritis	2
Hernia, Inguinal	2

Clinical Trial Locations for PERCOCET

Trials by Country

Trials by Country for PERCOCET
Location	Trials
United States	58
Canada	7
Israel	1

Trials by US State

Trials by US State for PERCOCET
Location	Trials
New York	15
Florida	3
California	3
Texas	3
Indiana	2

Clinical Trial Progress for PERCOCET

Clinical Trial Phase

Clinical Trial Phase for PERCOCET
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	23
Phase 3	7

Clinical Trial Status

Clinical Trial Status for PERCOCET
Clinical Trial Phase	Trials
Completed	31
Terminated	6
Recruiting	5

Clinical Trial Sponsors for PERCOCET

Sponsor Name

Sponsor Name for PERCOCET
Sponsor	Trials
Montefiore Medical Center	4
New York University School of Medicine	3
NYU Langone Health	3

Sponsor Type

Sponsor Type for PERCOCET
Sponsor	Trials
Other	60
Industry	8
NIH	5

PERCOCET (oxycodone/acetaminophen) clinical trials update, market analysis, and launch-risk projections

Last updated: July 25, 2026

What clinical trials are ongoing for PERCOCET (oxycodone acetaminophen)?

PERCOCET is an established, immediate-release combination of oxycodone (opioid analgesic) and acetaminophen (antipyretic/analgesic). The product’s clinical-development footprint is not centered on new PERCOCET-specific Phase 2-3 programs in the way it would be for a novel drug. Trial activity in the public domain typically concentrates on:

• Opioid analgesia comparative studies (often using oxycodone-containing products rather than PERCOCET specifically).
• Fixed-dose combination pharmacokinetics and bioavailability work.
• Abuse-deterrent and tamper-resistance research streams across the broader oxycodone class.
• Safety signal assessments and real-world evidence.

Because PERCOCET’s regulatory posture relies on an already-approved immediate-release regimen, the most material “clinical trial updates” for commercial planning are usually changes in opioid prescribing standards, risk management programs, and label/safety communications rather than new pivotal efficacy trials.

How big is the PERCOCET market, and what share does oxycodone/acetaminophen capture?

PERCOCET sits inside the oxycodone immediate-release and opioid combination segment. Market size and share are driven by:

• U.S. opioid prescribing volumes.
• Conversion from short-course acute pain prescribing to alternative analgesics (including NSAIDs, adjuvant analgesics, and non-opioid multimodal regimens).
• Payer restrictions and step therapy.
• Opioid reformulation and litigation-driven commercial adjustments across oxycodone brands.
• Substitution between oxycodone combination products and single-entity oxycodone, based on cost and access.

Commercial forecasting for PERCOCET should be modeled as “volume elasticity” to opioid prescribing rather than pure “brand demand.” Immediate-release opioid combination demand typically declines faster than long-acting opioids when formularies tighten.

Market drivers by channel

• Commercial pharmacy: impacted by formulary tiering, prior authorization, and quantity limits.
• Medicaid/managed care: typically tighter limits and opioid policy controls.
• Hospital/ED: influenced by acute pain pathways and institutional opioid stewardship.

When will PERCOCET face major exclusivity or generic pressure?

PERCOCET is not a protected, near-term launch asset in the way new entrants are; it is a legacy brand with broad availability of generic equivalents of oxycodone/acetaminophen. The principal market exposure is already “generic-led,” meaning the brand’s revenue trajectory depends on continued differentiated availability (product packaging, distribution agreements, and physician habit) rather than exclusivity extension.

What to model for market projection

• Ongoing erosion from generic substitution (often the dominant factor).
• Remnant brand demand via supply stability and contract pharmacy behavior.
• Any label or risk-management tightening that changes prescribing behavior.

What is the Orange Book status of PERCOCET?

PERCOCET’s Orange Book listing is expected to include already-expired or near-expired patent estates typical of legacy combination analgesics. Public-facing exclusivity for legacy immediate-release oxycodone/acetaminophen products is generally not a primary lever for forecasting incremental commercial upside.

What patents protect oxycodone/acetaminophen combinations like PERCOCET?

Patent protection for oxycodone/acetaminophen combinations generally falls into several buckets:

• Composition-of-matter and early combination patents that are typically far outside active life.
• Formulation/process patents that may or may not remain, depending on the specific NDA and strength.
• Method-of-use patents that can cover dosing or therapeutic regimens, often with limited practical enforcement for established products.

For PERCOCET specifically, the practical answer for business planning is that the active competitive set is dominated by generic equivalents, with litigation or patent disputes focused on discrete formulation or manufacturing tactics only if they exist and are still enforceable.

How does PERCOCET compare with other oxycodone/acetaminophen products?

Competitive substitution is typically “within-class”:

• Other oxycodone/acetaminophen immediate-release generics and brands.
• Alternative opioid combinations and opioid monotherapies.
• Non-opioid analgesic substitution driven by guidelines and payer policies.

Brand vs generic competitive dynamics

• Price compression is the main force once generics are available.
• Brand retention is mostly behavioral: prescriber comfort, institutional contracts, and perceived product reliability.

What generic entry risks exist for PERCOCET?

For PERCOCET, the risk profile is “not new entrants at the NDA level” but ongoing generic share expansion and any additional market-access consolidation by major generic manufacturers. Key business risks include:

• Further formulary exclusions or step edits by PBMs.
• Increased quantity limits and opioid stewardship protocols.
• Supply and distribution realignment away from legacy brands.

What patent litigation affects PERCOCET or its generics?

For legacy opioids, litigation typically reflects a mix of:

• Product-specific patent disputes (if any remaining enforceable patents exist).
• Broader opioid supply-chain and public nuisance litigation (structural market impacts through bankruptcy, settlements, and business practice changes).
• Settlement agreements that can influence timing and distribution, but typically not in the form of new NDA “at-risk” launches for PERCOCET at this stage.

What FDA and REMS issues affect PERCOCET?

All products containing oxycodone carry class-wide opioid risk management expectations. Commercial impact comes from:

• FDA opioid safety communications and label changes over time.
• Guidance affecting patient selection, dosing, and duration.
• Warnings tied to respiratory depression, misuse, abuse, and overdose risk.
• Naloxone availability and prescriber education expectations.

For PERCOCET, these factors translate into changes in prescribing behavior and restrictions at payer and system levels.

How should you project PERCOCET revenue from now through 2028?

A usable projection framework for PERCOCET is a three-factor model:

1. Baseline demand trajectory

• Declining or flat volume depending on acute pain prescribing trends.
• Faster declines in restricted channels (managed care) and slower declines in less restricted channels.

2. Share drift

• Brand share typically continues to erode versus generics.
• Share depends on formulary placement, contract incentives, and availability.

3. Price and reimbursement

• Brand pricing benefits may be limited by PBM-driven net price declines.
• Generic-driven price compression reduces revenue growth unless brand share stabilizes.

Projection ranges (scenario model)

Because PERCOCET is a legacy, genericized product, base-case forecasting generally assumes:

• Net revenue declines in the absence of major policy reversals.
• More pronounced declines if formulary tightening accelerates.
• Floor behavior if the brand retains a small share through institutional contracts or supply reliability.

Best estimate business stance: PERCOCET behaves like a mature, declining asset with modest headroom from any stabilization in acute pain volumes, partially offset by pricing pressure.

Key milestones that can bend the curve

• State and payer opioid policy updates (quantity limits, prior authorization criteria).
• FDA label changes that tighten indicated use or highlight overdose risk mitigation.
• Major generic manufacturer consolidation or supply disruptions that temporarily increase brand substitution.

What are the most likely commercial outcomes if you license or invest in PERCOCET-related assets?

Licensing or investment opportunities in legacy oxycodone/acetaminophen combinations usually hinge on:

• Securing differentiated distribution terms and contracting leverage.
• Targeting niche channels less restrictive on immediate-release opioids.
• Using portfolio optimization to hedge against broader opioid decline, not to expect category growth.

Key Takeaways

• PERCOCET is an established immediate-release oxycodone/acetaminophen product; public clinical-trial updates are not typically centered on new PERCOCET pivotal programs.
• Market performance is driven primarily by opioid prescribing volumes, formulary access, and ongoing generic substitution.
• Exclusivity and patent-based upside is limited in practical terms because legacy combination products face broad generic competition.
• Revenue projections should be modeled as a mature asset with continued share erosion and policy-driven volume headwinds.

FAQs

1) Is PERCOCET still prescribed widely in the U.S.?

Yes, but usage is constrained by tighter payer controls, opioid stewardship policies, and ongoing substitution to other analgesics and generic oxycodone/acetaminophen products.

2) How does PERCOCET differ from immediate-release oxycodone alone?

PERCOCET is a fixed-dose combination with acetaminophen, which changes dosing and safety monitoring (notably acetaminophen-related liver risk) relative to single-entity oxycodone.

3) What are the main risks for PERCOCET market access?

PBM formulary exclusion, step edits, quantity limits, and opioid-risk mitigation requirements that reduce patient eligibility and daily dose persistence.

4) Do there exist any biosimilar or biologic risks for PERCOCET?

No. PERCOCET is a small-molecule chemical drug, so biosimilar frameworks do not apply.

5) What events would most improve PERCOCET prospects?

Any reversal or relaxation of opioid access restrictions, stabilization of acute pain prescribing volumes, or improved net pricing through contracting leverage.

References

1. U.S. Food and Drug Administration (FDA). Drug Safety Communications and opioid-related labeling updates.
2. U.S. Food and Drug Administration (FDA). FDA-approved drug labeling for oxycodone/acetaminophen products (PERCOCET and related immediate-release combinations).
3. FDA Approved Drug Products: Orange Book database. (Product and patent listing records for oxycodone/acetaminophen immediate-release combinations).