List of Excipients in Branded Drug OXYCODONE AND ACETAMINOPHEN

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Generic Drugs Containing OXYCODONE AND ACETAMINOPHEN

Company	Ingredient	NDC	Excipient
West-Ward Pharmaceuticals Corp	oxycodone and acetaminophen	0054-0551	CELLULOSE, MICROCRYSTALLINE
West-Ward Pharmaceuticals Corp	oxycodone and acetaminophen	0054-0551	CROSCARMELLOSE SODIUM
West-Ward Pharmaceuticals Corp	oxycodone and acetaminophen	0054-0551	SILICON DIOXIDE
West-Ward Pharmaceuticals Corp	oxycodone and acetaminophen	0054-0551	STEARIC ACID

What are the Most Frequently-Used Excipients in OXYCODONE AND ACETAMINOPHEN?

# Of NDCs	Excipient
1	ALUMINUM OXIDE
1	BERRY
106	CELLULOSE, MICROCRYSTALLINE
71	CROSCARMELLOSE SODIUM

Oxycodone and Acetaminophen Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Oxycodone and acetaminophen is a mature, genericized combination with limited conventional patent protection and continuing demand in acute pain. Commercial value is concentrated in formulation differentiation, hospital and retail supply reliability, abuse-deterrence positioning, dose flexibility, and lifecycle products rather than exclusivity on the active ingredients.

The principal product is immediate-release oral oxycodone hydrochloride plus acetaminophen. Common strengths include 2.5/325 mg, 5/325 mg, 7.5/325 mg, and 10/325 mg per tablet. Percocet is the best-known reference brand, but the market is supplied primarily by generic manufacturers. FDA-approved products also include oral solutions and other dosage forms, creating opportunities for excipient-led differentiation.

What patents protect oxycodone and acetaminophen products?

The core composition is generally off-patent. Commercial protection for standard immediate-release oxycodone/acetaminophen tablets is limited because the active ingredients have been used together for decades and generic approval pathways are well established.

Product or product class	Regulatory position	Patent and exclusivity profile
Immediate-release oxycodone/acetaminophen tablets	Approved NDA and numerous ANDAs	Core composition protection is expired or commercially immaterial
Percocet	Reference-listed drug marketed by Endo or authorized generic channels, depending on product and period	No meaningful current market exclusivity for standard tablets
Generic tablets	ANDA products	Subject to Orange Book-listed patents, labeling requirements, and controlled-substance quotas
Oxycodone/acetaminophen oral solution	Approved prescription product class	Differentiation depends on formulation, concentration, device, and manufacturing controls
Extended-release oxycodone/acetaminophen	Limited commercial opportunity	Xartemis XR was a distinct extended-release product, but its commercial status and market availability differ from standard immediate-release tablets
Abuse-deterrent products	Product-specific formulation protection may apply	Protection depends on formulation patents, regulatory labeling, and demonstrated abuse-deterrent performance

FDA’s Orange Book remains the controlling source for current listed patents, patent certifications, and reference-product information. The existence of a patent on an oxycodone product does not mean that standard oxycodone/acetaminophen tablets retain enforceable protection. Product-specific patents may cover release technology, coating systems, tamper resistance, manufacturing processes, or devices rather than the basic drug combination. [1]

When does oxycodone and acetaminophen lose exclusivity?

Standard immediate-release products lost practical market exclusivity many years ago. Generic oxycodone/acetaminophen products are approved through ANDAs, and multiple manufacturers compete in the U.S. market.

The relevant commercial constraints are now:

• DEA Schedule II controls.
• FDA manufacturing and supply requirements.
• Acetaminophen dose and safety limitations.
• Opioid quota allocation.
• State prescribing restrictions.
• Hospital formulary access.
• Wholesaler and pharmacy supply contracts.
• Product recalls and shortage exposure.

A new entrant should not assume that an expired patent estate means frictionless entry. Controlled-substance registration, quota management, diversion controls, validation, and supply continuity can be more significant barriers than patent expiration.

What excipients are used in oxycodone and acetaminophen tablets?

Immediate-release tablets typically use conventional pharmaceutical excipients to support powder flow, direct compression or granulation, tablet strength, disintegration, coating, stability, and product identification.

Representative excipient functions include:

Excipient category	Typical function	Commercial relevance
Microcrystalline cellulose	Diluent and compression aid	Supports robust low-dose tablet manufacture
Lactose, starch, or mannitol	Diluent and mouthfeel modifier	Can affect cost, moisture sensitivity, and patient tolerability
Povidone or copovidone	Binder	Improves granule and tablet strength
Crospovidone or sodium starch glycolate	Superdisintegrant	Controls immediate-release tablet breakup
Colloidal silicon dioxide	Glidant	Improves flow and content uniformity
Magnesium stearate or stearic acid	Lubricant	Reduces tooling friction; excessive levels can delay dissolution
Hypromellose or other film-coating polymers	Coating and appearance	Can improve handling, identification, and light protection
Talc and titanium dioxide	Coating aids and opacifiers	Support appearance and barrier properties
Pharmaceutical colors	Product identification	Useful for strength differentiation and counterfeit screening

Actual excipients vary by manufacturer and dosage strength. The reference product label and each generic product label should be reviewed separately because excipient composition is not standardized across ANDA products. FDA’s Inactive Ingredient Database provides a regulatory benchmark for prior use by route and dosage form. [2]

What excipient strategy is best for immediate-release tablets?

The lowest-risk strategy is a conventional, rapidly disintegrating tablet using well-established excipients already accepted in oral solid dosage forms. The design objective is reproducible dissolution and content uniformity, not maximum formulation novelty.

A practical formulation platform should:

1. Maintain immediate release across all strengths.
2. Avoid unnecessary excipients that create allergy, intolerance, or supply risks.
3. Use color and imprint differentiation to reduce dispensing errors.
4. Control acetaminophen and oxycodone content uniformity independently.
5. Support scale-up across multiple tablet strengths.
6. Minimize lubricant sensitivity and dissolution drift.
7. Use excipients with established regulatory precedent in opioid combination products.

The principal technical risk is disproportionate dissolution behavior between the two active ingredients. Oxycodone hydrochloride and acetaminophen have different physicochemical properties, dose ratios, and analytical responses. Blend uniformity, segregation, granulation, and compression controls must be designed around both actives rather than the higher-mass acetaminophen component.

What formulation patents could create commercial differentiation?

The strongest formulation opportunities are not basic excipient substitutions. They involve a clinically or operationally meaningful product attribute.

Abuse-deterrent formulation

An abuse-deterrent oxycodone/acetaminophen product could use a hard matrix, gelling system, aversive excipient, physical barrier, or combination technology. The formulation would need to demonstrate resistance to one or more manipulation routes, such as crushing, chewing, extraction, or dissolution.

Potential excipient technologies include:

• High-viscosity hydrophilic polymers.
• Polyethylene oxide matrices.
• Cross-linked polymer systems.
• Intumescent or hardening agents.
• Irritant or aversive components.
• Barrier coatings.
• Multilayer tablets.
• Lipid or wax-based matrices.

The commercial case is stronger for oxycodone-only products than for oxycodone/acetaminophen products because acetaminophen creates an additional toxicity concern when manipulated or taken at excessive doses. Any abuse-deterrent design must avoid increasing acetaminophen release or creating extraction behavior that undermines the product’s safety rationale.

FDA approval with abuse-deterrent labeling requires product-specific evidence under the FDA’s abuse-deterrent guidance. Abuse-deterrent technology does not eliminate misuse, addiction, overdose, or diversion. [3]

Orally disintegrating and multiparticulate products

An orally disintegrating tablet could address patients with swallowing difficulty, emergency department use, or post-operative administration. It would need to manage the bitter taste of oxycodone and acetaminophen without compromising rapid disintegration.

Possible excipient tools include:

• Mannitol for mouthfeel.
• Crospovidone for rapid disintegration.
• Ion-exchange resins for taste masking.
• Polymer coatings for drug particles.
• Flavors and sweeteners.
• Low-moisture packaging.
• Specialized blister systems.

The principal commercial limitation is opioid abuse risk. A rapidly disintegrating or easily extractable product may face greater scrutiny than a conventional tablet.

Oral solution

An oral solution can serve pediatric, geriatric, hospice, and swallowing-impaired populations. It also allows dose titration, but it creates higher diversion, dosing-error, and accidental-ingestion risks.

Key excipient requirements include:

• Solubilizers or co-solvents.
• Buffer systems.
• Preservatives, if multidose packaging is used.
• Sweeteners and flavors.
• Viscosity modifiers.
• Container-closure systems with dose-measuring devices.
• Child-resistant packaging.

A concentrated solution may reduce administration volume but increase the risk of medication error. A differentiated product should pair concentration selection with a calibrated oral syringe and clear dose labeling.

What is the FDA regulatory status of oxycodone and acetaminophen?

Oxycodone and acetaminophen products are prescription drugs. Oxycodone is a Schedule II controlled substance under the Controlled Substances Act. The combination is subject to controlled-substance manufacturing, storage, distribution, prescribing, recordkeeping, and quota requirements. [4]

FDA approval depends on the dosage form and regulatory pathway:

Development route	Typical use
ANDA	Generic equivalent with the same active ingredients, dosage form, strength, route, and bioequivalence
505(b)(2) NDA	Modified formulation, new dosage form, new delivery system, or other change supported by some reliance on existing data
Full NDA	New active combination or product requiring a complete development package

A conventional tablet using the same active ingredients and dosage form will normally be an ANDA candidate. A novel abuse-deterrent matrix, oral solution concentration, orally disintegrating tablet, or modified-release product may require a 505(b)(2) NDA, depending on the product’s differences and reference-product landscape.

How many patents cover oxycodone and acetaminophen products?

There is no single patent count for the category. Patent coverage must be assessed by product, dosage form, manufacturer, and jurisdiction.

For standard immediate-release tablets, the economically relevant patent count is generally low because:

• The active ingredients are long established.
• The combination is widely genericized.
• Conventional excipients do not usually support broad, durable exclusivity.
• Many formulation patents are narrow or vulnerable to design-around.
• The commercial reference product has multiple approved generic equivalents.

For a differentiated formulation, the relevant patent estate may include:

1. Composition-of-matter claims for a novel excipient combination.
2. Release-profile claims.
3. Abuse-deterrence claims.
4. Manufacturing-process claims.
5. Particle-size or coating claims.
6. Dosage-regimen claims.
7. Container-closure and dosing-device claims.
8. Method-of-use claims.

A robust estate should contain overlapping claims directed to the formulation, manufacturing process, product performance, and use. A single broad formulation patent is less resilient if competitors can reproduce the clinical effect with a different polymer, coating, or process.

What formulation patents are commercially valuable?

The most valuable claims are those that are difficult to design around and easy to detect in a marketed product.

High-value claim areas include:

• A defined polymer-to-drug ratio that produces a measurable release profile.
• A tamper-resistant matrix with specified mechanical or extraction properties.
• A multiparticulate system with controlled coating thickness.
• A stable oral solution with a defined pH, preservative system, and shelf life.
• A dosage device that limits administration errors.
• A manufacturing process that produces a distinct microstructure or release profile.
• A combination of formulation features required for FDA labeling.

Lower-value claim areas include routine substitution of one binder for another, standard tablet colors, conventional diluents, and excipient choices that are common in the FDA Inactive Ingredient Database.

What Paragraph IV challenges affect oxycodone and acetaminophen?

Paragraph IV challenges are most relevant when an ANDA applicant seeks approval before expiration of an Orange Book-listed patent. The applicant certifies that the patent is invalid, unenforceable, or will not be infringed.

For standard immediate-release oxycodone/acetaminophen tablets, Paragraph IV litigation is less likely to create a durable barrier because core market protection has expired and generic competition is established. The litigation risk increases for:

• Abuse-deterrent formulations.
• Extended-release products.
• New oral solutions.
• Orally disintegrating products.
• Device-enabled delivery systems.
• New method-of-use indications.
• 505(b)(2) products relying on a protected formulation.

A Paragraph IV filing can trigger a 30-month stay of approval in qualifying circumstances, but the stay applies to the challenged product and patents, not to the entire oxycodone/acetaminophen market. [1]

What method-of-use patents could protect oxycodone and acetaminophen?

Method-of-use protection is limited by the mature clinical use of the combination. Potential claims could address:

• A defined post-operative pain regimen.
• Use in a particular surgical population.
• A reduced-acetaminophen dosing protocol.
• Use with a specific patient population.
• A formulation designed to reduce dosing frequency.
• A co-therapy approach intended to reduce opioid exposure.

Such patents face practical limits. Physicians may prescribe generic immediate-release products outside the patented indication, and branded manufacturers must demonstrate commercially meaningful differentiation. Labeling strategy, prescriber adoption, and enforcement visibility are critical.

Which companies compete in the oxycodone and acetaminophen market?

The market includes the reference-brand owner, authorized generic channels, specialty generic manufacturers, large diversified generic companies, and contract manufacturers.

Competitive advantages are usually based on:

• FDA-approved manufacturing capacity.
• DEA quota access.
• API sourcing.
• Reliable supply during shortages.
• National wholesaler coverage.
• Hospital contracts.
• Low cost of goods.
• Multiple strengths and package sizes.
• Recall and quality history.
• Controlled-substance compliance systems.

Common competitors in the broader U.S. generic opioid market have included companies such as Teva, Amneal, Hikma, Rhodes Pharmaceuticals, Mallinckrodt, Endo-related entities, and other ANDA holders. The specific supplier set changes as products are discontinued, acquired, relabeled, or placed on allocation.

What generic launch risks exist?

A generic launch faces four primary risks.

Regulatory risk

The product must meet ANDA requirements for pharmaceutical equivalence, bioequivalence, stability, labeling, and manufacturing controls. Modified formulations may require a 505(b)(2) pathway rather than an ANDA.

Supply risk

Oxycodone products require dependable controlled-substance API access. DEA quota limits can constrain production even when tablet capacity is available. Acetaminophen is widely available, but dual-source qualification remains important.

Commercial price risk

The immediate-release market is heavily commoditized. A new conventional tablet may receive limited volume unless it has a supply, contract, package, or service advantage.

Liability and compliance risk

Opioid products carry heightened scrutiny involving diversion, suspicious-order monitoring, dispensing controls, labeling, and promotional restrictions. An excipient strategy that improves abuse deterrence or dosing accuracy may produce more commercial value than a modest manufacturing-cost reduction.

What licensing deals are available for oxycodone and acetaminophen?

Licensing opportunities are most credible in enabling technology rather than the basic combination. Relevant assets include:

• Abuse-deterrent polymer platforms.
• Taste-masking systems.
• Controlled-release matrices.
• Oral liquid stabilization technology.
• Child-resistant and unit-dose packaging.
• Dose-measuring devices.
• Low-cost continuous manufacturing.
• Technologies that reduce acetaminophen exposure while preserving analgesic efficacy.

A license should be assessed against freedom-to-operate in the United States, Europe, Canada, and other controlled-substance markets. Key diligence points include patent term, continuation applications, prosecution history, formulation ownership, regulatory precedent, manufacturing scale-up, and whether the technology supports FDA abuse-deterrent labeling.

How strong is the patent estate for oxycodone and acetaminophen?

The estate is weak for conventional immediate-release tablets and potentially moderate for a genuinely differentiated formulation.

Product strategy	Patent strength	Commercial outlook
Conventional IR tablet	Low	Volume, price, and supply competition
Low-cost multi-strength platform	Low to moderate	Useful for generic portfolio expansion
Oral solution with dosing device	Moderate	Niche value in institutional and specialty channels
Orally disintegrating tablet	Moderate	Differentiation possible, but abuse-risk scrutiny is high
Abuse-deterrent tablet	Moderate to strong if claims are broad and validated	Premium and contracting opportunity
Extended-release product	Product-specific	Depends on clinical profile, patents, and current availability
Novel method of use	Variable	Requires strong labeling and enforcement strategy

Geographic protection is also uneven. U.S. patent and regulatory rights do not automatically extend to Europe, Japan, Canada, or emerging markets. Controlled-substance rules, local combination-product practices, and reimbursement systems affect each market separately.

What revenue exposure does oxycodone and acetaminophen create?

For a conventional generic manufacturer, revenue exposure is driven by volume and supply continuity, not price power. A single product may have limited strategic value unless it is part of a broader pain portfolio containing oxycodone, hydrocodone, tramadol, non-opioid analgesics, or hospital products.

A differentiated formulation can command stronger economics through:

• Hospital formulary contracts.
• Specialty pharmacy distribution.
• Institutional packaging.
• Authorized-generic arrangements.
• Abuse-deterrent positioning.
• Reduced dispensing errors.
• Product availability during generic shortages.

Forecasts should model rapid generic price erosion for an unprotected tablet. A branded or 505(b)(2) formulation requires separate assumptions for development cost, clinical evidence, manufacturing scale, controlled-substance quota, payer coverage, and litigation.

What is the best commercial strategy for oxycodone and acetaminophen?

The most defensible strategy is a platform approach:

1. Develop a conventional immediate-release tablet only if manufacturing cost, supply reliability, or market access creates a clear advantage.
2. Use a common excipient architecture across multiple strengths.
3. Avoid unnecessary formulation novelty in an ANDA product.
4. Pursue an abuse-deterrent or dosing-error-reduction product through a 505(b)(2) strategy if the technology supports meaningful differentiation.
5. Build a controlled-substance compliance system before commercial launch.
6. Protect the formulation with layered composition, process, performance, and device claims.
7. Secure dual-source API and critical-excipient supply.
8. Use packaging, imprinting, and strength differentiation to reduce medication errors.
9. Prioritize institutional and specialty channels where operational value can offset generic price pressure.

Key Takeaways

• Standard oxycodone/acetaminophen immediate-release tablets are mature, genericized products with limited core patent value.
• Excipients should first support dissolution, content uniformity, stability, manufacturability, and dose identification.
• Conventional excipient substitutions rarely create durable commercial exclusivity.
• Abuse-deterrent systems, oral solutions, orally disintegrating products, and dosing devices offer stronger differentiation but require higher regulatory and development investment.
• Oxycodone’s Schedule II status makes DEA quota, diversion controls, and supply reliability central commercial issues.
• Paragraph IV risk is limited for standard tablets and more relevant for novel formulations.
• The strongest new patent estates combine formulation, manufacturing, performance, device, and method-of-use claims.
• Generic revenue is volume-driven. Premium economics require a differentiated product, reliable supply, institutional access, or regulatory labeling advantage.

FAQs

Can a new excipient alone support a patent for oxycodone and acetaminophen?

Usually not. A patent is more defensible when the excipient produces a measurable technical result, such as abuse resistance, controlled release, improved stability, or a distinct dissolution profile.

Is an abuse-deterrent oxycodone/acetaminophen product commercially attractive?

It can be, but the product must justify additional development cost, demonstrate meaningful abuse-deterrent properties, obtain appropriate FDA labeling, and secure payer or institutional adoption.

Can oxycodone and acetaminophen be developed as an ANDA product?

A conventional product with the same active ingredients, dosage form, strength, route, and performance characteristics may qualify for an ANDA. A materially modified formulation may require a 505(b)(2) NDA.

Are oral solutions protected by different excipient strategies?

Yes. Oral solutions require different controls for solubility, taste, preservation, pH, viscosity, packaging, dosing accuracy, and accidental ingestion risk.

What is the main barrier to launching a generic oxycodone/acetaminophen tablet?

The main barriers are controlled-substance compliance, DEA quota, manufacturing approval, supply reliability, and price competition. Patent protection is usually not the primary barrier for standard immediate-release tablets.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

2. U.S. Food and Drug Administration. (2024). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

3. U.S. Food and Drug Administration. (2015). Guidance for industry: Abuse-deterrent opioids: Evaluation and labeling. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abuse-deterrent-opioids-evaluation-and-labeling

4. U.S. Drug Enforcement Administration. (2024). Controlled substance schedules. https://www.dea.gov/drug-information/drug-scheduling

5. U.S. Food and Drug Administration. (2011). Acetaminophen prescription combination drug products with more than 325 mg: FDA statement. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-prescription-acetaminophen-products-be-limited-325-mg-dosage-unit

6. National Library of Medicine. (2024). DailyMed: Oxycodone hydrochloride and acetaminophen labeling. https://dailymed.nlm.nih.gov/dailymed/