List of Excipients in Branded Drug PERCOCET

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Generic Drugs Containing PERCOCET

Company	Ingredient	NDC	Excipient
STAT RX USA LLC	oxycodone hydrochloride and acetaminophen	16590-619	CELLULOSE, MICROCRYSTALLINE
STAT RX USA LLC	oxycodone hydrochloride and acetaminophen	16590-619	CROSCARMELLOSE SODIUM
STAT RX USA LLC	oxycodone hydrochloride and acetaminophen	16590-619	CROSPOVIDONE
STAT RX USA LLC	oxycodone hydrochloride and acetaminophen	16590-619	FD&C BLUE NO. 1
STAT RX USA LLC	oxycodone hydrochloride and acetaminophen	16590-619	POVIDONE

What are the Most Frequently-Used Excipients in PERCOCET?

# Of NDCs	Excipient
5	CELLULOSE, MICROCRYSTALLINE
5	CROSCARMELLOSE SODIUM
6	CROSPOVIDONE
1	D&C YELLOW NO. 10
1	FD&C BLUE NO. 1

PERCOCET Excipient Strategy and Commercial Opportunities: Formulation, Generic Competition, and Regulatory Analysis

Last updated: October 2, 2026

Percocet is an immediate-release, fixed-dose combination of oxycodone hydrochloride and acetaminophen. Its commercial differentiation is limited because the core tablet technology is mature, the active ingredients are widely available, generic oxycodone/acetaminophen products compete directly, and no meaningful exclusivity barrier protects the conventional formulation. Commercial opportunity is concentrated in excipient optimization, abuse-deterrent delivery, dose flexibility, manufacturing efficiency, and differentiated non-opioid combination products.

What is the Percocet formulation and which excipients does it contain?

Percocet tablets contain oxycodone hydrochloride and acetaminophen in immediate-release strengths. Current labeled strengths include 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg, expressed as oxycodone hydrochloride and acetaminophen per tablet.[1]

The labeled inactive ingredients include conventional tablet excipients used for flow, compression, disintegration, binding, lubrication, and appearance.

Excipient category	Representative Percocet excipients	Primary function
Diluent and compression aid	Microcrystalline cellulose	Tablet bulk and compactability
Binder	Povidone, pregelatinized starch	Granule and tablet strength
Disintegrants	Crospovidone, croscarmellose sodium, sodium starch glycolate	Tablet breakup and drug release
Glidant	Colloidal silicon dioxide	Powder flow and content uniformity
Lubricant	Stearic acid	Reduction of die-wall friction
Processing aid	Starch-based excipients	Granulation and mechanical strength
Color and opacity agents	Titanium dioxide and strength-specific colorants	Product identification and appearance

Exact colorants and excipient quantities can vary by strength and manufacturer. Generic products are not required to use the same excipient system as the reference listed drug, provided they meet applicable quality, bioequivalence, labeling, and manufacturing requirements.[1,2]

The formulation is technically conventional. It does not depend on a controlled-release matrix, lipid system, enteric coating, multiparticulate platform, or complex device.

What excipient strategy is appropriate for Percocet generic products?

The preferred strategy is a low-risk, direct-compression or wet-granulation platform that achieves bioequivalence with a short development cycle and robust commercial manufacturing.

Direct-compression strategy

A direct-compression formulation can use:

• Microcrystalline cellulose or a co-processed cellulose excipient as the principal diluent.
• Crospovidone or croscarmellose sodium as the principal superdisintegrant.
• Colloidal silicon dioxide as a glidant.
• Magnesium stearate or stearic acid as a lubricant.
• Low-substitution hydroxypropyl cellulose or povidone as a dry binder when needed.

Direct compression reduces processing steps and can lower manufacturing cost. The principal risks are segregation, poor flow, punch sticking, tablet weight variability, and content uniformity, particularly because oxycodone is present at a low dose relative to acetaminophen and the total tablet mass.

Wet-granulation strategy

Wet granulation is appropriate when the formulation has poor flow, inadequate compactability, or unacceptable content-uniformity risk. Povidone or pregelatinized starch can improve granule strength and reduce segregation.

The tradeoff is a longer process, greater validation burden, and potential exposure of acetaminophen to moisture. Granulation conditions should be controlled to limit assay drift, degradation, and changes in dissolution.

Excipient selection priorities

A commercially viable excipient system should prioritize:

1. Rapid and reproducible disintegration.
2. Consistent dissolution across strengths.
3. Low lubricant sensitivity.
4. Robust low-dose oxycodone content uniformity.
5. Low moisture uptake.
6. Compatibility with high-speed tablet presses.
7. Acceptable tablet hardness without delayed drug release.
8. Broad supplier availability.
9. Established compendial status.
10. Low risk of excipient-related regulatory review.

A formulation that copies the functional performance of the reference product without copying its exact composition is generally more valuable than a formulation built around an unusual excipient with limited regulatory precedent.

What formulation patents protect Percocet?

The conventional immediate-release Percocet tablet has limited current formulation-patent protection. The commercial product is based on a mature oxycodone-acetaminophen combination, and the principal opportunity for generic manufacturers is an abbreviated new drug application rather than a license to a protected platform.

Potentially relevant patent categories include:

• Oxycodone-acetaminophen combination patents.
• Immediate-release tablet composition patents.
• Abuse-deterrent opioid formulations.
• Taste-masked or orally disintegrating formulations.
• Low-dose opioid delivery systems.
• Manufacturing processes for improved content uniformity.
• Methods of reducing oxycodone misuse or extraction.
• Alternative acetaminophen dose regimens.

These categories must be distinguished from currently enforceable Percocet protection. A patent may be expired, assigned to a different product, excluded from the Orange Book, or directed to a formulation that does not cover the marketed immediate-release product.

The FDA Orange Book is the controlling source for listed patents and regulatory exclusivity associated with an approved drug application.[2] Patent status should be reviewed by product strength, dosage form, NDA, and patent-use code. A general search for "Percocet patent" is not sufficient to establish a launch barrier.

What is the Orange Book status of Percocet?

Percocet is an FDA-approved prescription opioid combination product. Its regulatory pathway is associated with oxycodone hydrochloride and acetaminophen tablets under an approved new drug application held by the brand sponsor or successor holder.[1,2]

The key commercial issue is that generic oxycodone/acetaminophen tablets are widely approved. Competition does not depend on a single future loss-of-exclusivity event. It is already established across multiple strengths and manufacturers.

Regulatory issue	Commercial implication
Immediate-release dosage form	Low technical barrier for conventional generics
Combination of two established actives	Requires bioequivalence to both active components
Schedule II opioid	Controlled-substance registration, quotas, security, and distribution controls apply
Acetaminophen component	Dose-related hepatotoxicity risk constrains label and formulation positioning
Generic competition	Price pressure and pharmacy substitution reduce brand differentiation
REMS environment	Opioid risk-management requirements affect commercialization

The existence of an approved brand does not itself create a current market monopoly. The relevant analysis is the combination of Orange Book patents, regulatory exclusivities, Paragraph IV litigation, settlement agreements, and state or federal controlled-substance requirements.

When does Percocet lose exclusivity?

The conventional Percocet formulation has already entered a mature generic market. There is no single upcoming exclusivity date that governs all oxycodone/acetaminophen tablets.

The practical exclusivity position is:

Exclusivity element	Current commercial assessment
NCE exclusivity	Not relevant to this mature combination product
Orphan exclusivity	Not applicable
Pediatric exclusivity	No general market barrier identified for the conventional product
Regulatory exclusivity	No broad current exclusivity barrier expected for established generic strengths
Composition patent	Conventional product protection is not a material generic barrier
Method-of-use protection	Limited commercial relevance for routine acute-pain prescribing
Manufacturing patents	Potentially relevant only to specific processes or differentiated products

Patent expiration should be confirmed against the current Orange Book and applicable patent assignments before a launch decision. Expired patents, unlisted patents, and patents directed to nonmarketed embodiments should not be treated as launch-blocking rights.

Which companies are challenging Percocet, and what is the generic landscape?

Generic competition comes from manufacturers of oxycodone hydrochloride and acetaminophen tablets, including large generic suppliers and specialized controlled-substance manufacturers. The competitive field can include companies such as Teva Pharmaceutical Industries, Amneal Pharmaceuticals, Hikma Pharmaceuticals, Rhodes Pharmaceuticals, and other FDA-approved applicants, subject to current product availability and manufacturing status.

The relevant competitors are not limited to products marketed under the Percocet name. They include:

• Oxycodone hydrochloride/acetaminophen tablets.
• Authorized generic versions.
• Hospital and institutional suppliers.
• Mail-order and specialty pharmacy distributors.
• Alternative short-acting opioid products.
• Non-opioid analgesic combinations.

Generic launch economics depend on supply reliability, DEA quota access, manufacturing capacity, payer contracts, and wholesaler allocation. A technically equivalent tablet may not gain meaningful share if the applicant cannot maintain controlled-substance supply.

Paragraph IV risk

A Paragraph IV certification is relevant when an ANDA applicant asserts that an Orange Book-listed patent is invalid, unenforceable, or will not be infringed. For a mature immediate-release product, Paragraph IV risk is usually lower than for a recently approved extended-release or abuse-deterrent opioid.

Commercial exposure can still arise if a listed patent covers:

• A specific dose combination.
• A manufacturing process.
• A formulation attribute.
• An abuse-deterrent feature.
• A method of use with a listed patent code.

The absence of a significant current patent barrier for the conventional Percocet tablet does not eliminate litigation risk. It shifts the risk toward product-specific patents, induced-infringement theories, manufacturing rights, and contractual disputes.

What commercial opportunities exist in Percocet excipient innovation?

The strongest opportunities are adjacent to the conventional tablet rather than attempts to create another standard generic.

1. Co-processed excipient systems

Co-processed excipients can improve flow, compactability, and disintegration while reducing formulation complexity. A supplier could target controlled-substance tablet manufacturers with a platform designed for:

• Low-dose active uniformity.
• High-speed compression.
• Reduced tablet weight.
• Low friability.
• Rapid release.
• Lower sensitivity to lubricant overmixing.

The commercial model may be excipient supply, formulation licensing, or a joint development agreement with a generic manufacturer.

2. Moisture-resistant systems

Acetaminophen and oxycodone formulations require stability control. Moisture-resistant excipient systems, protective film coats, and low-water-activity manufacturing processes can reduce degradation and improve shelf life.

The opportunity is strongest where the excipient system produces measurable stability improvement without delaying dissolution or increasing tablet cost.

3. Abuse-deterrent formulations

An abuse-deterrent oxycodone-acetaminophen product could use:

• Polyethylene oxide or high-viscosity polymer matrices.
• Hard-to-crush tablet structures.
• Gelling systems that impede syringeability.
• Sequestration technologies.
• Physical barriers to extraction.
• Combination designs that reduce rapid oxycodone release after manipulation.

FDA approval requires evidence that the product has abuse-deterrent properties under applicable FDA guidance. Abuse-deterrent labeling does not mean abuse-proof performance and does not eliminate the need for opioid REMS compliance.[3]

This segment carries higher development costs and patent risk but offers more differentiation than a conventional immediate-release generic.

4. Low-acetaminophen or opioid-sparing products

Acetaminophen creates a dose ceiling because excessive exposure can cause severe liver injury. A differentiated product could seek to reduce total acetaminophen exposure while preserving analgesic efficacy through:

• Lower acetaminophen strengths.
• Flexible oxycodone dosing.
• Non-opioid co-analgesic combinations.
• Patient-specific dosing formats.
• Short-duration treatment packs.

Any new combination would require a separate regulatory strategy and would not automatically qualify as a generic Percocet product.

5. Pediatric and geriatric usability

Oral liquids, sprinkle formulations, orally disintegrating tablets, and smaller-dose units may address swallowing and dose-flexibility problems. These products face higher formulation and abuse-diversion considerations because liquid and rapidly dissolving formats can increase misuse risk.

A commercially attractive product must balance dosing precision with controlled-substance security and packaging requirements.

How strong is the patent estate for Percocet excipient technology?

The patent estate for a conventional Percocet-style tablet is weak as a barrier to generic entry. Patent strength is higher for new delivery technologies with measurable technical performance.

Technology	Patent strength potential	Development burden	Commercial differentiation
Conventional direct-compression tablet	Low	Low	Low
Novel co-processed excipient system	Moderate	Low to moderate	Moderate
Moisture-protective formulation	Moderate	Moderate	Moderate
Abuse-deterrent matrix	High	High	High
Orally disintegrating tablet	Moderate	Moderate	Moderate
Pediatric liquid	Moderate	Moderate	Moderate
Opioid-sparing combination	High if clinically differentiated	High	High

Patent claims should focus on measurable structure-function relationships, such as dissolution after crushing, extraction resistance, gel strength, particle-size distribution, moisture activity, or specific impurity limits. Broad claims to familiar excipients are vulnerable to enablement, written-description, obviousness, and anticipation challenges.

A stronger portfolio can combine:

• Composition claims.
• Process claims.
• Abuse-deterrence performance claims.
• Stability claims.
• Packaging claims.
• Use claims where legally available.
• Trade-secret protection for process parameters and scale-up controls.

What manufacturing and IP barriers affect a Percocet opportunity?

The main barriers are operational rather than excipient availability.

Controlled-substance manufacturing

Manufacturers must comply with DEA registration, security, recordkeeping, quota, inventory, and distribution requirements. Oxycodone supply is subject to controlled-substance oversight, and manufacturing scale may be constrained by quota allocation and supply-chain controls.[4]

Content uniformity

Oxycodone is a low-dose component relative to acetaminophen. Segregation during blending, transfer, and compression can create assay and content-uniformity problems. Excipient particle size, density, and surface properties are central to process control.

Tablet strength and dissolution

Higher tablet hardness can improve handling but delay disintegration. Excess lubricant can reduce wettability and slow release. Superdisintegrant selection and mixing time require optimization across all strengths.

Packaging and diversion controls

Unit-dose blister packaging, child-resistant systems, tamper-evident features, and serialization can support institutional and pharmacy sales. Packaging is also a potential source of patent protection, though its value depends on enforceability and actual customer adoption.

What licensing deals are available for Percocet-related excipient technology?

Licensing opportunities are more likely to involve platform technologies than the Percocet brand itself.

Potential deal structures include:

• A formulation license to a generic manufacturer.
• An excipient supply agreement tied to minimum volumes.
• A co-development agreement for an abuse-deterrent opioid.
• A manufacturing technology transfer.
• A patent license covering extraction resistance or controlled release.
• A regional commercialization agreement.
• A royalty-bearing license for a pediatric or orally disintegrating dosage form.

The most valuable license package would combine a defendable patent estate, regulatory data, validated manufacturing parameters, and supply assurance. An excipient alone is usually weak negotiating leverage unless it produces a clear bioequivalence, stability, productivity, or abuse-deterrence advantage.

What FDA regulatory status and commercialization risks apply?

Percocet is an FDA-approved opioid analgesic combination product. Commercialization is subject to opioid labeling, controlled-substance requirements, postmarket surveillance, and applicable REMS obligations.[1,3,4]

Key risks include:

• Respiratory depression.
• Misuse, abuse, addiction, and diversion.
• Acetaminophen-associated hepatotoxicity.
• Drug-drug interactions involving CYP3A4 or CYP2D6 pathways.
• Supply interruption caused by quota or manufacturing constraints.
• Recall risk from content-uniformity or dissolution failures.
• State-level opioid restrictions.
• Payer substitution and generic price erosion.

A new excipient strategy must not create a release profile that increases oxycodone exposure, accelerates absorption, or undermines label comparability. Products with novel release behavior may require a 505(b)(2) application or a full new drug application rather than a standard ANDA.

How does Percocet compare with competing opioid formulations?

Product category	Active ingredient profile	Excipient opportunity	Patent and regulatory profile
Generic oxycodone/acetaminophen tablet	Immediate-release oxycodone plus acetaminophen	Cost, stability, manufacturability	Mature and highly competitive
Oxycodone extended-release	Oxycodone alone or specialized delivery	Abuse deterrence and release control	Higher technical and patent barriers
Hydrocodone/acetaminophen	Different opioid plus acetaminophen	Similar dose and stability issues	Competes for acute-pain prescriptions
Tramadol/acetaminophen	Lower opioid potency combination	Taste, dose flexibility, tablet robustness	Different safety and efficacy profile
Non-opioid analgesic combinations	No oxycodone	Patient usability and tolerability	Potential growth where opioid exposure is limited

Percocet-style products compete primarily on availability, price, prescriber familiarity, pharmacy access, and payer coverage. Excipient innovation becomes commercially meaningful only when it supports a differentiated regulatory claim or solves a manufacturing problem.

What generic launch scenarios exist for Percocet-related products?

Scenario 1: Conventional ANDA generic

This is the lowest-risk regulatory path. The product uses standard excipients, demonstrates bioequivalence, and competes on cost and supply reliability. Margins are likely to be constrained by multiple approved suppliers.

Scenario 2: Premium generic with manufacturing advantage

A manufacturer uses a co-processed excipient system to improve throughput, reduce rejects, or stabilize supply. The product may not command a large price premium but can generate margin through lower cost of goods and better service levels.

Scenario 3: Abuse-deterrent oxycodone combination

This approach requires substantial formulation, abuse-potential, clinical, and regulatory work. It can create stronger differentiation but faces higher development expense, patent scrutiny, and uncertain payer adoption.

Scenario 4: 505(b)(2) differentiated product

A novel dosage form, lower-acetaminophen regimen, pediatric product, or opioid-sparing combination could pursue a 505(b)(2) pathway. Commercial value depends on clinical differentiation and whether the product obtains meaningful labeling or exclusivity.

What revenue exposure does Percocet create?

Brand-specific Percocet revenue is difficult to isolate from broader oxycodone/acetaminophen sales because generic substitution is extensive and public company reporting often aggregates products within controlled-substance or pain portfolios.

The principal revenue exposure is therefore category-based:

• Declining conventional tablet prices.
• Contract losses caused by supply interruptions.
• Margin compression from additional generic entrants.
• Volume migration to alternative opioids or non-opioid therapies.
• Compliance costs associated with controlled-substance distribution.
• Liability and litigation reserves.
• Potential premium pricing for differentiated abuse-deterrent products.

For an excipient supplier, the addressable opportunity is the total volume of oxycodone/acetaminophen tablets manufactured, not the retail sales of the Percocet brand alone.

Key Takeaways

• Percocet is an immediate-release oxycodone hydrochloride and acetaminophen tablet with a conventional excipient platform.
• The conventional formulation has limited current exclusivity value because generic oxycodone/acetaminophen competition is established.
• The most practical excipient strategy is direct compression or wet granulation optimized for low-dose oxycodone uniformity, rapid disintegration, stability, and high-throughput production.
• Co-processed excipients, moisture protection, abuse-deterrent systems, and flexible lower-acetaminophen products offer stronger commercial opportunities than another standard generic tablet.
• DEA controls, quota access, supply reliability, and opioid compliance are major commercial barriers.
• Patent value is highest for abuse-deterrent performance, measurable extraction resistance, novel dosage forms, and validated manufacturing processes.
• A new conventional formulation generally supports an ANDA strategy. A materially novel delivery system may require a 505(b)(2) or full NDA pathway.
• Current Orange Book listings, patent-use codes, assignments, and litigation records must control any final launch or licensing decision.

FAQs

Can a generic Percocet manufacturer use different excipients?

Yes. A generic applicant can use different inactive ingredients if the product satisfies FDA requirements for pharmaceutical equivalence, bioequivalence, quality, labeling, and safety.

Which excipients are most important for oxycodone content uniformity?

Microcrystalline cellulose, colloidal silicon dioxide, binders, and the particle-size and density characteristics of the powder blend are central. Blend segregation and transfer losses are major process risks.

Can an excipient supplier patent a Percocet-compatible formulation?

Yes, but the strongest claims should cover a novel composition, manufacturing process, stability result, or abuse-deterrent performance. Claims limited to routine use of known excipients are vulnerable to invalidity challenges.

Does an abuse-deterrent Percocet formulation automatically receive market exclusivity?

No. Abuse-deterrent properties may support a differentiated product and patent claims, but exclusivity depends on the specific regulatory pathway, patent listings, approved labeling, and applicable statutory protections.

Is acetaminophen reduction a commercial opportunity in oxycodone combinations?

Yes. Lowering acetaminophen exposure can address dose-related liver-safety concerns, but the product would require appropriate regulatory support and may not qualify as a conventional generic of the reference product.

References

1. U.S. Food and Drug Administration. (2024). Percocet: Oxycodone hydrochloride and acetaminophen tablets prescribing information. Endo Pharmaceuticals Inc.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Center for Drug Evaluation and Research.

3. U.S. Food and Drug Administration. (2015). Guidance for industry: Abuse-deterrent opioids: Evaluation and labeling. U.S. Department of Health and Human Services.

4. U.S. Drug Enforcement Administration. (2024). Controlled substances act and DEA registration requirements. U.S. Department of Justice.