OXYCODONE HYDROCHLORIDE AND IBUPROFEN Drug Patent Profile

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Which patents cover Oxycodone Hydrochloride And Ibuprofen, and what generic alternatives are available?

Oxycodone Hydrochloride And Ibuprofen is a drug marketed by Actavis Elizabeth, Barr Labs Inc, and Watson Labs. and is included in three NDAs.

The generic ingredient in OXYCODONE HYDROCHLORIDE AND IBUPROFEN is ibuprofen; oxycodone hydrochloride. There is one drug master file entry for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for OXYCODONE HYDROCHLORIDE AND IBUPROFEN

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	81
Patent Applications:	31
DailyMed Link:	OXYCODONE HYDROCHLORIDE AND IBUPROFEN at DailyMed

Recent Clinical Trials for OXYCODONE HYDROCHLORIDE AND IBUPROFEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Texas Scottish Rite Hospital for Children	PHASE2
University of North Carolina, Chapel Hill	PHASE4
Keck School of Medicine of USC	PHASE3

See all OXYCODONE HYDROCHLORIDE AND IBUPROFEN clinical trials

US Patents and Regulatory Information for OXYCODONE HYDROCHLORIDE AND IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078769-001	Jan 4, 2008		DISCN	No	No
Barr Labs Inc	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078316-001	Nov 29, 2007		DISCN	No	No
Watson Labs	OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	078394-001	Nov 26, 2007		DISCN	No	No

Oxycodone Hydrochloride and Ibuprofen Market Dynamics, Patent Status, and Financial Trajectory

Last updated: October 31, 2026

Oxycodone hydrochloride and ibuprofen is a fixed-dose opioid/nonsteroidal anti-inflammatory drug combination marketed in the United States under the brand Combunox and through generic equivalents. The product contains oxycodone hydrochloride 5 mg and ibuprofen 400 mg per tablet. Its commercial profile is mature and largely genericized. Revenue is concentrated in low-priced generic prescriptions, while market growth is constrained by opioid prescribing controls, boxed-warning requirements, and competition from non-opioid analgesics.

What is oxycodone hydrochloride and ibuprofen?

Oxycodone hydrochloride and ibuprofen combines a Schedule II opioid with a nonsteroidal anti-inflammatory drug. The FDA-approved indication is the short-term management of acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate.

The standard strength is:

Component	Amount per tablet
Oxycodone hydrochloride	5 mg
Ibuprofen	400 mg
Dosage form	Immediate-release tablet
Administration	Oral
DEA status	Schedule II because of oxycodone
Approved use	Short-term acute pain

The formulation is intended for short-duration therapy. The ibuprofen component provides peripheral analgesic and anti-inflammatory activity, while oxycodone provides central opioid analgesia. The product is not designed for chronic pain treatment, long-term maintenance therapy, or opioid-use-disorder treatment.

The FDA labeling limits use to no more than four tablets per day and no more than seven consecutive days because of the cumulative risks associated with ibuprofen and oxycodone exposure. The maximum daily ibuprofen dose under that regimen is 1,600 mg, while oxycodone exposure is 20 mg per day.[1]

When did oxycodone hydrochloride and ibuprofen receive FDA approval?

The FDA lists Combunox as having an initial U.S. approval in 1997. The product was developed as a fixed-dose analgesic combination and later became available through generic approvals.

FDA regulatory profile

Regulatory element	Status
Active ingredients	Oxycodone hydrochloride and ibuprofen
Original brand	Combunox
Original approval	1997
FDA application type	New Drug Application for the branded product; Abbreviated New Drug Applications for generics
Controlled-substance classification	Schedule II
Dosage form	Immediate-release oral tablet
Pediatric status	Restricted labeling; safety and effectiveness depend on age and clinical context
Current commercial model	Generic-dominated

The combination is subject to opioid labeling requirements, medication-guide requirements, and FDA risk-management controls applicable to prescription opioids. FDA labeling warns of respiratory depression, addiction, abuse, misuse, overdose, neonatal opioid withdrawal, and risks from concomitant central nervous system depressants.[1]

What patents protect oxycodone hydrochloride and ibuprofen?

The original product’s principal patent value has expired. The combination does not have the type of active, high-value patent estate associated with a recently approved branded drug.

Patent and exclusivity position

Protection category	Current commercial significance
Original composition or combination patents	Expired or commercially exhausted
FDA new-drug exclusivity	Expired
Orange Book-listed active patents	No meaningful barrier to ordinary generic entry identified in the mature U.S. market
Method-of-use patents	No material barrier identified for the core acute-pain indication
Formulation patents	No commercially significant current barrier identified for the immediate-release tablet
Manufacturing patents	Potentially relevant to individual suppliers, but not a broad market-entry barrier
Generic substitution	Established

The relevant intellectual-property position is therefore based on ordinary pharmaceutical manufacturing capability, supplier qualification, controlled-substance compliance, and commercial scale rather than enforceable exclusivity around the active combination.

The FDA Orange Book remains the controlling source for current listed patents, exclusivity, and reference-product information. A historical patent can remain important for litigation analysis even after expiry, but it does not prevent current generic substitution once the enforceable term has ended.[2]

When does oxycodone hydrochloride and ibuprofen lose exclusivity?

The product lost meaningful U.S. market exclusivity years ago. Combunox is no longer protected by the commercial exclusivity that would support premium branded pricing.

The product’s exclusivity timeline is broadly:

Period	Market event
1997	Initial FDA approval of the fixed-dose combination
Late 1990s to 2000s	Brand commercialization and development of generic competition
2000s onward	Generic oxycodone/ibuprofen products enter the market
2010s	Opioid-control measures and prescription-volume pressure increase
Current market	Mature generic market with limited brand pricing power

There is no credible basis for a new exclusivity cycle unless a company develops a materially differentiated product, such as an abuse-deterrent formulation, extended-release delivery system, new route of administration, or a new FDA-approved indication. A reformulation would require separate regulatory and intellectual-property analysis.

What is the Orange Book status of oxycodone hydrochloride and ibuprofen?

The reference product is Combunox. The active commercial opportunity is associated with generic abbreviated new drug applications rather than an unchallenged branded product.

Generic applicants generally rely on an ANDA demonstrating pharmaceutical equivalence and bioequivalence to the reference listed drug. The relevant approval pathway does not require the generic applicant to repeat the full clinical efficacy program conducted for the original product.

Orange Book and ANDA implications

A generic applicant must address any listed patents through one or more of the following certifications:

• Paragraph I: no patent information has been submitted.
• Paragraph II: the listed patent has expired.
• Paragraph III: the applicant will wait until patent expiration.
• Paragraph IV: the listed patent is invalid, unenforceable, or will not be infringed.

For this mature combination, Paragraph IV litigation is commercially less central than it is for a recently launched branded drug. The original patent position has aged beyond the period when a first generic entrant could normally capture a large exclusivity premium.

Which companies manufacture oxycodone hydrochloride and ibuprofen?

The market has included the Combunox brand and multiple generic suppliers. Generic availability can change because of controlled-substance quotas, manufacturing economics, product discontinuations, and FDA supply-chain actions.

Potential participants include:

• The original Combunox commercialization chain.
• Generic pharmaceutical manufacturers with approved ANDAs.
• Contract manufacturers producing controlled-substance tablets.
• Distributors and specialty wholesalers handling Schedule II products.
• Pharmacies and hospital systems purchasing through generic contracts.

The exact active supplier set should be measured through current FDA approval records, commercial wholesaler catalogs, and National Drug Code data. Approval does not guarantee continuous commercial supply.

How does oxycodone hydrochloride and ibuprofen compare with competing analgesics?

The combination competes against both opioid products and non-opioid treatments. Its market position depends on the prescriber’s assessment of pain severity, expected duration, gastrointestinal risk, renal risk, and opioid exposure.

Product category	Competitive advantage	Main limitation
Oxycodone/ibuprofen	Combines opioid and anti-inflammatory analgesia in one tablet	Opioid dependence risk and ibuprofen-related gastrointestinal, renal, and cardiovascular risks
Oxycodone/acetaminophen	Familiar opioid combination with broad prescribing history	Acetaminophen liver-toxicity ceiling
Hydrocodone/acetaminophen	Large historical prescribing base	Opioid and acetaminophen risks
Ibuprofen alone	Low cost and no opioid exposure	May be inadequate for severe acute pain
Naproxen	Longer anti-inflammatory duration	Similar NSAID safety concerns
Tramadol	Lower perceived opioid potency	Dependence, seizure, serotonin, and variable-response risks
Local anesthetics and regional blocks	Opioid-sparing potential	Procedure-specific and administration-dependent
Multimodal non-opioid therapy	Supports opioid reduction	Requires multiple agents or interventions

The combination’s clinical rationale is strongest where acute inflammatory pain requires more than an NSAID alone but where a short opioid course is still considered appropriate. Its commercial weakness is that regulators, health systems, and prescribers increasingly favor opioid-sparing protocols.

What generic entry risks exist for oxycodone hydrochloride and ibuprofen?

Generic entry risk is high because the product has no meaningful remaining exclusivity barrier. The principal risk is not a sudden patent-triggered launch but continued price erosion and supplier turnover.

Generic-market risk factors

1. Multiple approved or potentially approved suppliers can compete on price.
2. Pharmacy benefit managers and wholesalers can substitute among equivalent products.
3. Controlled-substance quotas may restrict supply from individual manufacturers.
4. Opioid litigation and compliance costs can reduce the number of willing suppliers.
5. Low unit prices limit the incentive to invest in specialized manufacturing capacity.
6. Prescribing restrictions reduce total demand.
7. Hospital protocols increasingly favor non-opioid and multimodal regimens.

Generic manufacturers also face product-liability exposure and compliance obligations that are more significant than for many non-controlled analgesics. Those costs can affect supply continuity even when patent barriers are absent.

What is the financial trajectory of oxycodone hydrochloride and ibuprofen?

No standalone public revenue series for oxycodone hydrochloride and ibuprofen is generally disclosed by the original brand owner or generic manufacturers. The product is not typically reported as a separate material revenue segment in public company filings. Financial analysis therefore relies on market structure, prescription volume, average selling price, and supplier participation.

Commercial trajectory

Phase	Financial characteristics
Brand launch	Higher price, limited competition, promotional and distribution investment
Early generic entry	Rapid unit-price decline and substitution
Mature generic period	Low prices, thin margins, volume-driven economics
Opioid-restriction period	Lower demand growth and greater compliance costs
Current market	Stable but constrained demand, with revenue concentrated among efficient suppliers

The original branded product likely experienced the standard fixed-dose-combination trajectory: initial pricing power followed by rapid deterioration after generic substitution. Current value is more likely to accrue through manufacturing scale, portfolio breadth, and distribution contracts than through brand premiums.

Revenue exposure by stakeholder

Stakeholder	Revenue exposure
Brand owner	Limited, unless branded supply remains commercially active
Generic manufacturer	Low-margin volume sales
Contract manufacturer	Production fees and controlled-substance capacity utilization
Distributor	Low per-unit margin with regulated handling requirements
Pharmacy	Dispensing economics and reimbursement spread
Payer	Cost savings from generic substitution, offset by opioid-utilization controls
Litigation or compliance function	Potential cost exposure unrelated to unit sales

The market is unlikely to generate significant growth without a change in clinical positioning, such as a new indication, a differentiated delivery system, or evidence supporting use in a defined acute-pain population. Those opportunities would face substantial regulatory, clinical, and liability hurdles.

What patent litigation affects oxycodone hydrochloride and ibuprofen?

No major current patent dispute is central to the U.S. commercial outlook for the mature oxycodone/ibuprofen combination. The product’s key legal risks are more likely to arise from:

• Opioid marketing and distribution litigation.
• Product-liability claims.
• Controlled-substance compliance investigations.
• Failure-to-warn allegations.
• Manufacturing-quality disputes.
• Contract and supply disagreements.
• State and federal opioid settlement obligations.

Patent litigation would become more relevant if a company introduced a new formulation, abuse-deterrent technology, delivery device, or differentiated therapeutic use. The basic immediate-release combination has limited room for new patent protection that would block ordinary generic tablets.

What is the biosimilar risk for oxycodone hydrochloride and ibuprofen?

There is no biosimilar risk because the product is a small-molecule drug, not a biologic. Competition occurs through generic drug regulation under the ANDA pathway, not through the FDA’s biosimilar pathway under the Biologics Price Competition and Innovation Act.

The relevant competitive risk is generic substitution, not biosimilar interchangeability.

What geographic markets matter for oxycodone hydrochloride and ibuprofen?

The United States is the most commercially relevant market because of the product’s historical brand presence, FDA approval framework, and extensive opioid regulation. International opportunities are constrained by:

• Different opioid scheduling systems.
• Country-specific registration requirements.
• Lower or absent demand for fixed-dose opioid/NSAID products.
• Local restrictions on oxycodone.
• Reimbursement limits.
• Variations in clinical guidelines.
• National procurement systems.

A manufacturer pursuing international sales would need separate regulatory approvals, controlled-substance permits, pharmacovigilance systems, and distribution controls. U.S. FDA approval does not create automatic foreign-market rights.

How strong is the patent estate for oxycodone hydrochloride and ibuprofen?

The patent estate is weak for the core product. The commercial barriers are regulatory and operational rather than exclusivity-based.

Patent-strength factor	Assessment
Core active ingredients	Weak, long-established molecules
Fixed-dose combination	Mature technology
Immediate-release tablet	Limited differentiation
Method of use	Narrow opportunity and established indication
Abuse-deterrent formulation	Potentially stronger, but would be a different product
Manufacturing process	Possible narrow protection, unlikely to block all suppliers
Regulatory exclusivity	Expired
Generic substitution risk	High

An investor or licensee should value the product as a mature generic asset rather than as a patent-protected branded franchise.

What generic launch scenarios are most likely?

The most likely scenario is continued generic availability with periodic supplier changes and ongoing price competition. Three commercial outcomes are plausible:

1. Multiple-supplier market: prices remain low, supply is relatively resilient, and no manufacturer has durable pricing power.
2. Concentrated-supplier market: a small number of companies remain because of controlled-substance compliance costs, creating occasional shortage risk.
3. Brand-retention niche: limited branded demand persists in selected channels, but the brand does not regain broad pricing power.

The second scenario is commercially important. A mature generic market can have low prices and still experience shortages if demand is concentrated among too few qualified manufacturers.

Key Takeaways

• Oxycodone hydrochloride and ibuprofen is a mature fixed-dose combination containing oxycodone 5 mg and ibuprofen 400 mg.
• Combunox received initial U.S. approval in 1997.
• The product has no meaningful remaining exclusivity barrier for ordinary generic tablets.
• Generic substitution, opioid controls, and non-opioid alternatives limit revenue growth.
• Standalone product revenue is not generally disclosed by manufacturers.
• Financial value is tied to manufacturing scale, supply reliability, and distribution access.
• Patent litigation is less important than controlled-substance compliance, product liability, and opioid-related legal exposure.
• The product is not subject to biosimilar competition.
• A differentiated abuse-deterrent or delivery technology could create new patent value, but it would represent a separate product development program.

FAQs

Is oxycodone hydrochloride and ibuprofen still sold under the Combunox brand?

Combunox is the historical reference brand. Current availability depends on commercial distribution and pharmacy inventory, while generic equivalents provide the principal market supply.

Is oxycodone hydrochloride and ibuprofen a controlled substance?

Yes. The oxycodone component makes the product a Schedule II controlled substance in the United States.

Can a generic manufacturer launch without repeating clinical trials?

Generally, yes. An ANDA applicant can rely on the reference product’s safety and efficacy findings by demonstrating pharmaceutical equivalence and bioequivalence, subject to FDA requirements.

Does oxycodone/ibuprofen have a meaningful patent moat?

No. The core combination is mature, and its principal commercial protections have expired or lost practical relevance.

What would increase the value of this drug franchise?

Value could increase through a differentiated abuse-deterrent formulation, a new delivery system, reliable supply during shortages, a targeted acute-pain indication, or a manufacturing platform that lowers controlled-substance production costs.

References

1. U.S. Food and Drug Administration. (2023). Combunox prescribing information: Oxycodone hydrochloride and ibuprofen tablets. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: The Orange Book. FDA.

3. U.S. Food and Drug Administration. (2023). Opioid analgesic risk evaluation and mitigation strategy. FDA.

4. U.S. Drug Enforcement Administration. (2024). Drug scheduling. U.S. Department of Justice.

5. U.S. Food and Drug Administration. (2024). Generic drug facts and abbreviated new drug applications. FDA.