Last updated: August 1, 2026
Percodan-Demi is a discontinued U.S. fixed-dose analgesic containing oxycodone hydrochloride and aspirin. No active clinical-development program, dedicated registered clinical-trial pipeline, current branded commercial market, or credible brand-specific revenue forecast supports a conventional growth projection. The relevant commercial opportunity is limited to historical product exposure and any residual demand for oxycodone-aspirin combination tablets.
What is Percodan-Demi?
Percodan-Demi was the lower-strength formulation of Percodan, an oral combination of an opioid analgesic and aspirin. The product was used for short-term management of moderate to severe pain when an opioid combination was considered appropriate.
| Attribute |
Percodan-Demi |
| Active ingredients |
Oxycodone hydrochloride and aspirin |
| Dosage form |
Immediate-release oral tablet |
| Therapeutic class |
Opioid analgesic and nonsteroidal anti-inflammatory analgesic combination |
| FDA regulatory pathway |
Historically approved prescription drug |
| Controlled-substance status |
Schedule II opioid product in the United States |
| Current branded status |
Discontinued |
| Current clinical-development status |
No active branded development program identified |
| Biosimilar relevance |
None |
| Primary competitive products |
Oxycodone-acetaminophen, hydrocodone-acetaminophen, oxycodone immediate-release tablets, nonopioid analgesics |
Percodan-Demi should not be confused with modern extended-release oxycodone products or with oxycodone-acetaminophen combinations such as Percocet. Its second active ingredient is aspirin, not acetaminophen.
What is the clinical-trial status of Percodan-Demi?
No active interventional clinical-trial program is associated with Percodan-Demi as a branded product. The product is an established combination analgesic rather than an investigational medicine, and its clinical evidence base consists primarily of historical approval-era studies, postmarketing experience, opioid safety data, and literature concerning oxycodone-aspirin combinations.
ClinicalTrials.gov is not a reliable source of an active product-specific development program for Percodan-Demi. Searches involving the product name and oxycodone-aspirin combinations generally identify either no active product-specific trials or studies addressing broader opioid prescribing, acute pain, postoperative pain, opioid use disorder, or comparative analgesia rather than Percodan-Demi itself (ClinicalTrials.gov, n.d.).
Are new clinical trials expected?
A new Percodan-Demi development program is unlikely without a substantial reformulation or a new clinical proposition. A sponsor seeking to revive the product would face:
- Schedule II opioid controls.
- Current FDA scrutiny of opioid abuse, misuse, addiction, overdose, and diversion risks.
- The need to justify the combination against oxycodone-only, oxycodone-acetaminophen, and nonopioid alternatives.
- Additional safety concerns from aspirin, including gastrointestinal bleeding and renal effects.
- Limited commercial differentiation from generic immediate-release opioid products.
- Difficulty obtaining favorable payer coverage for an obsolete fixed-dose combination.
A reformulated oxycodone-aspirin product could require new clinical studies if the sponsor sought a new indication, altered strength, abuse-deterrent labeling, modified pharmacokinetics, or a new delivery system. Those studies would concern the reformulated product, not the historical Percodan-Demi formulation.
What is the FDA status of Percodan-Demi?
Percodan-Demi is not an actively marketed branded product in the U.S. The FDA maintains separate records for approved drug products, discontinued products, labeling, and marketing status. A product can remain listed in historical regulatory records after commercial discontinuation.
The key regulatory distinction is:
| Regulatory question |
Assessment |
| Was the product historically approved? |
Yes, as an oxycodone-aspirin prescription analgesic |
| Is the branded product actively marketed? |
No current branded market is identified |
| Is the product an investigational drug? |
No |
| Is there an active FDA development program? |
No |
| Does the product have biologic exclusivity? |
No |
| Is biosimilar competition relevant? |
No |
| Is generic substitution the principal risk? |
Historically yes, although current availability is limited |
| Is opioid scheduling relevant? |
Yes, because oxycodone products are Schedule II controlled substances |
FDA’s discontinued-drug records should be used to confirm the exact regulatory marketing status of any specific national drug code or label version (U.S. Food and Drug Administration, n.d.-a).
What patents protect Percodan-Demi?
No active, commercially meaningful patent estate is associated with the historical Percodan-Demi brand.
The likely patent position is as follows:
| Patent category |
Current relevance |
| Active ingredient patents |
Expired |
| Historical combination patents |
Expired or commercially irrelevant |
| Formulation patents |
No active product-specific estate identified |
| Method-of-use patents |
No active branded estate identified |
| Manufacturing patents |
No known barrier specific to Percodan-Demi |
| Orange Book-listed patents |
No meaningful current listing supporting brand exclusivity |
| Regulatory exclusivity |
Expired |
| Pediatric exclusivity |
Not commercially relevant |
| Orphan-drug exclusivity |
Not applicable |
Percodan-Demi contains long-established small-molecule ingredients. Oxycodone and aspirin are both off-patent. Any historical patent protection would have expired long before the current market period. A new patent could potentially cover a novel abuse-deterrent matrix, release profile, dose ratio, or manufacturing process, but such protection would apply only to the new technology and would not revive exclusivity for the legacy product.
Does Percodan-Demi have Orange Book protection?
Percodan-Demi has no current Orange Book position that creates a meaningful barrier to generic or alternative opioid entry. The Orange Book can include discontinued products and historical listings, but listing status is not equivalent to active commercial exclusivity.
For an active branded product, Orange Book-listed patents can support a Paragraph IV litigation strategy. That framework has little practical relevance to a discontinued Percodan-Demi product because:
- The legacy composition is long off-patent.
- No current branded sponsor is defending a commercially important product franchise.
- Generic manufacturers do not need to overcome a live, high-value patent estate.
- The principal barriers are manufacturing economics, controlled-substance quotas, regulatory compliance, and demand rather than patent rights.
Have companies filed Paragraph IV challenges against Percodan-Demi?
No commercially significant current Paragraph IV litigation campaign is associated with Percodan-Demi.
Paragraph IV litigation is generally initiated when a generic applicant certifies that a listed patent is invalid, unenforceable, or will not be infringed. The product’s discontinued status and lack of a meaningful active patent estate remove the commercial incentive for a major challenge.
Any historical abbreviated new drug application activity involving oxycodone-aspirin tablets would be more relevant to generic approval history than to an ongoing litigation contest. The absence of current litigation does not imply that the formulation is protected. It reflects the lack of a commercially important branded product and enforceable exclusivity.
What is the market size for Percodan-Demi?
The current branded market for Percodan-Demi is effectively zero. The product does not have a reliable current revenue base, active sales force, meaningful promotional budget, or visible clinical-development investment.
A brand-specific market forecast should therefore be presented as a residual-market scenario rather than a conventional prescription-drug forecast.
| Forecast period |
Base-case brand revenue outlook |
Commercial interpretation |
| Current period |
Approximately $0 |
No active branded sales platform |
| Near term |
Approximately $0 |
No identified relaunch or development catalyst |
| Medium term |
Approximately $0 |
Generic and substitute products remain more practical |
| Upside case |
Low and uncertain |
Requires relaunch, new sponsor, supply, and regulatory strategy |
| Downside case |
$0 |
Continued discontinuation |
The broader oxycodone combination market is materially larger than the Percodan-Demi market, but it should not be attributed to Percodan-Demi. That market includes oxycodone-acetaminophen products, oxycodone-only products, and other opioid formulations with different clinical, regulatory, and commercial profiles.
What is the competitive landscape for Percodan-Demi?
Percodan-Demi competes poorly against products with greater current availability, stronger physician familiarity, or more flexible dosing.
| Competitor |
Main advantage over Percodan-Demi |
Main limitation |
| Oxycodone immediate-release tablets |
Flexible oxycodone dosing without fixed aspirin exposure |
Opioid-related abuse and overdose risk |
| Oxycodone-acetaminophen |
Established prescribing base and broad generic supply |
Acetaminophen liver-toxicity ceiling |
| Hydrocodone-acetaminophen |
Large historical prescription base |
Opioid and acetaminophen risks |
| NSAIDs |
No opioid dependence risk |
Gastrointestinal, renal, and cardiovascular risks |
| Acetaminophen |
Low cost and broad availability |
Lower efficacy for severe pain |
| Tramadol |
Lower perceived opioid intensity |
Seizure, serotonin, and opioid-related risks |
| Nonpharmacologic pain treatment |
Avoids drug toxicity |
Limited applicability for severe acute pain |
Aspirin creates a less attractive safety profile for many patients than acetaminophen or an opioid-only formulation. The fixed ratio also limits dose optimization.
What manufacturing and intellectual-property barriers exist?
The formulation has low intellectual-property barriers but meaningful operational barriers.
Manufacturing considerations
A manufacturer would need to manage:
- Schedule II oxycodone procurement and quota allocation.
- Controlled-substance security, recordkeeping, and diversion controls.
- Uniformity of a low-dose oxycodone component in a combination tablet.
- Aspirin stability and moisture sensitivity.
- Packaging and serialization requirements.
- FDA inspection and quality-system obligations.
- Forecasting risk in a low-volume product category.
These issues can make production uneconomic even when the formulation is technically straightforward.
Intellectual-property considerations
The legacy formulation has little practical patent protection. A relaunch would require a differentiated product, such as:
- Abuse-deterrent technology.
- A novel immediate-release release profile.
- A new dose ratio.
- A lower-risk delivery system.
- A narrowly defined clinical indication.
- A manufacturing process with defensible claims.
Patent protection alone would not solve the product’s limited clinical differentiation or opioid-related regulatory burden.
What licensing deals involve Percodan-Demi?
No current licensing transaction, acquisition, co-development agreement, or commercialization partnership of material significance is associated with Percodan-Demi.
A future transaction would likely concern a broader opioid portfolio, controlled-substance manufacturing platform, or abuse-deterrent technology rather than the historical Percodan-Demi brand. The asset would have low standalone licensing value unless paired with:
- An approved manufacturing site.
- Existing DEA quota.
- A differentiated formulation.
- A commercial opioid portfolio.
- Reimbursement or institutional-contracting access.
- A strategy for reintroducing discontinued prescription products.
What generic launch risks exist?
Generic entry risk is not the central issue because the branded product is already discontinued. If a manufacturer sought to launch an oxycodone-aspirin equivalent, the principal risks would be commercial rather than patent-based.
Generic launch scenarios
Scenario 1: No relaunch
This is the most probable outcome. No sponsor invests in reintroducing a legacy combination with limited differentiation and opioid-related regulatory exposure.
Scenario 2: Limited generic supply
A manufacturer launches a small-volume oxycodone-aspirin tablet for institutional or niche demand. Sales remain constrained by prescribing reluctance, procurement economics, and controlled-substance requirements.
Scenario 3: Reformulated relaunch
A sponsor develops a new abuse-deterrent or modified-release product. This could support new patents and potentially a premium price, but it would require regulatory investment and clinical justification.
Scenario 4: Portfolio acquisition
A specialty pharmaceutical company acquires the historical brand or formulation rights as part of a larger analgesic portfolio. The brand remains commercially marginal unless the acquirer has a specific supply-chain or contracting rationale.
How strong is the Percodan-Demi patent estate?
The estate is weak for current commercial purposes.
| Strength factor |
Assessment |
| Composition-of-matter protection |
None remaining |
| Formulation protection |
No meaningful active protection identified |
| Method-of-use protection |
No meaningful active protection identified |
| Orange Book leverage |
Minimal |
| Patent litigation leverage |
Minimal |
| Regulatory exclusivity |
None |
| Manufacturing know-how |
Not a material barrier |
| Relevance to biosimilar competition |
None |
| Overall estate strength |
Very low |
The product’s strategic value rests neither on exclusivity nor on clinical differentiation. Any potential value would come from manufacturing capability, historical brand recognition, or inclusion in a larger controlled-substance portfolio.
What is the projected commercial outlook?
The projected outlook for Percodan-Demi is inactive to negligible.
A realistic projection is:
- No meaningful new clinical-trial activity.
- No material patent-expiration event because the relevant protection has already expired.
- No current branded revenue stream.
- No identifiable biosimilar or specialty-generic threat.
- Low probability of a standalone relaunch.
- Limited potential value in a broader opioid portfolio transaction.
- Greater commercial relevance for oxycodone-acetaminophen and oxycodone-only products than for oxycodone-aspirin tablets.
The product could only support a material forecast if a sponsor announced a concrete relaunch, submitted a new application, secured supply and DEA quota, or introduced a differentiated formulation. Without one of those events, a revenue projection above a negligible residual level would not be supportable.
Key Takeaways
- Percodan-Demi is a discontinued oxycodone-aspirin analgesic.
- No active product-specific clinical-trial program is identified.
- The legacy composition has no meaningful remaining patent or regulatory exclusivity.
- Current branded revenue is effectively zero.
- Orange Book and Paragraph IV issues have limited practical relevance.
- Biosimilar risk does not apply because the product is a small-molecule drug.
- Generic or alternative analgesic competition is stronger than the product’s current commercial position.
- A relaunch would require a new commercial rationale, reliable controlled-substance supply, and likely formulation differentiation.
- The most probable forecast is continued market inactivity rather than recovery or growth.
FAQs
Is Percodan-Demi still available by prescription?
No active branded commercial supply is identified. Availability of any oxycodone-aspirin equivalent would depend on current manufacturer distribution and pharmacy inventory.
Is Percodan-Demi the same as Percocet?
No. Percodan-Demi contains oxycodone and aspirin. Percocet contains oxycodone and acetaminophen.
Can a generic manufacturer launch Percodan-Demi?
A manufacturer could pursue an oxycodone-aspirin abbreviated application if it met FDA requirements and obtained compliant controlled-substance supply. The principal challenge would be commercial viability rather than an active patent barrier.
Does Percodan-Demi have biosimilar competition?
No. Biosimilars apply to biological products. Percodan-Demi is a small-molecule combination drug.
Would a new abuse-deterrent Percodan-Demi receive new patent protection?
Potentially, if the product used a novel and patentable formulation or delivery system. Any new rights would protect the new technology, not the expired historical composition.
References
-
ClinicalTrials.gov. (n.d.). Search results for Percodan-Demi and oxycodone-aspirin clinical studies. U.S. National Library of Medicine. https://clinicaltrials.gov/
-
U.S. Food and Drug Administration. (n.d.-a). Discontinued drugs. https://www.fda.gov/drugs/drug-approvals-and-databases/discontinued-drugs
-
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
-
U.S. Drug Enforcement Administration. (n.d.). Drug scheduling. https://www.dea.gov/drug-information/drug-scheduling
-
U.S. Food and Drug Administration. (n.d.-c). Percodan prescribing information. DailyMed. https://dailymed.nlm.nih.gov/
