PERCOCET Drug Patent Profile

Which patents cover Percocet, and what generic alternatives are available?

Percocet is a drug marketed by Ozantri and Vintage Pharms Llc and is included in three NDAs.

The generic ingredient in PERCOCET is acetaminophen; oxycodone hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for PERCOCET

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	53
Patent Applications:	109
Drug Prices:	Drug price information for PERCOCET
DailyMed Link:	PERCOCET at DailyMed

See drug prices for PERCOCET

See drug sales revenues for PERCOCET

Recent Clinical Trials for PERCOCET

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

Sponsor	Phase
University of Manitoba	PHASE3
Albany Medical College	Phase 4
Henry Ford Health System	Phase 4

See all PERCOCET clinical trials

Pharmacology for PERCOCET

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for PERCOCET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ozantri	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330-001	Jun 25, 1999	AA	RX	No	Yes
Vintage Pharms Llc	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040341-002	Jul 26, 1999		DISCN	No	No
Ozantri	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330-003	Nov 23, 2001	AA	RX	No	Yes
Ozantri	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330-002	Jun 25, 1999	AA	RX	No	Yes

Percocet Market Dynamics, Patent Exclusivity, Generic Competition, and Financial Trajectory

Last updated: September 24, 2026

Percocet is an immediate-release combination of oxycodone hydrochloride and acetaminophen. Its commercial market is mature, heavily genericized, and constrained by opioid prescribing controls, addiction concerns, acetaminophen safety limits, and extensive federal and state litigation. The brand has limited strategic value compared with the broader oxycodone/acetaminophen market, where competition is driven mainly by generic pricing, wholesaler access, manufacturing capacity, and controlled-substance compliance.

The key commercial conclusion is that Percocet is no longer an exclusivity-driven pharmaceutical asset. Its financial trajectory depends on residual brand demand, generic volume, opioid-market contraction, and litigation or compliance costs rather than patent-protected pricing.

What is Percocet and how is the product positioned?

Percocet combines oxycodone hydrochloride, an opioid agonist, with acetaminophen, a non-opioid analgesic. The product is approved for the management of pain severe enough to require an opioid analgesic when alternative treatments are inadequate.[1]

The product is available in several immediate-release strength combinations, including:

Oxycodone/acetaminophen strength	Typical commercial positioning
2.5 mg/325 mg	Lower-dose immediate-release treatment
5 mg/325 mg	Common entry strength
7.5 mg/325 mg	Intermediate strength
10 mg/325 mg	Higher-strength immediate-release treatment

Earlier formulations contained higher acetaminophen loads, including 500 mg and 650 mg presentations. FDA actions and labeling changes reduced the maximum acetaminophen content in prescription combination products to 325 mg per dosage unit because of liver-injury risk.[2]

Percocet is a Schedule II controlled substance in the United States. The product carries boxed warnings covering addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal, and risks from benzodiazepine co-use.[1]

How large is the Percocet and oxycodone-acetaminophen market?

The precise standalone Percocet market size is not publicly disclosed in current SEC filings or FDA databases. Public company reporting generally aggregates branded and generic pain products, while commercial market-research providers use proprietary prescription and sales datasets.

The economically relevant market is the broader U.S. immediate-release oxycodone/acetaminophen market. Its main demand drivers are:

• Acute postoperative pain.
• Emergency-department and urgent-care prescribing.
• Dental procedures.
• Trauma and short-term injury treatment.
• Limited chronic-pain use where other treatments are inadequate.
• Hospital discharge prescriptions.

Demand has declined structurally from the peak opioid-prescribing period. CDC data show that U.S. opioid prescribing rates fell materially from their 2010 peak through 2022, although prescribing remains substantial and varies by state and clinical specialty.[3]

The market has also shifted toward lower-dose prescriptions, smaller quantities, prescription-drug-monitoring controls, and non-opioid alternatives. Generic oxycodone/acetaminophen products supply most unit volume because the active ingredients and immediate-release delivery system are longstanding and readily substitutable.

When did Percocet lose exclusivity?

Percocet lost meaningful market exclusivity decades ago. The original product was approved in the 1970s, and generic oxycodone/acetaminophen products have been marketed for many years.[4]

No current commercial thesis depends on an active Percocet composition-of-matter patent. The immediate-release combination does not have the patent profile of a recently approved product, a long-acting delivery system, or a biologic.

Percocet exclusivity timeline

Event	Timing or status
Original FDA approval	1970s
Generic oxycodone/acetaminophen entry	Established for many years
Current meaningful small-molecule exclusivity	None identified
Current biosimilar exclusivity	Not applicable
Current branded pricing power	Limited
Primary competitive mechanism	Generic substitution and supply availability

The FDA Orange Book remains the principal source for approved product information, patent listings, and regulatory exclusivity. Current Orange Book analysis should distinguish the original Percocet NDA from later generic ANDAs and from discontinued or no-longer-marketed presentations.[4]

What patents protect Percocet today?

No active patent estate appears to provide material market protection for the legacy immediate-release Percocet formulation. The product’s core technical attributes are:

• Oxycodone hydrochloride as the opioid active ingredient.
• Acetaminophen as the non-opioid active ingredient.
• Immediate-release oral tablets.
• Conventional excipients and manufacturing processes.

Those characteristics are generally vulnerable to generic replication. Any historical formulation or manufacturing patents associated with the legacy product would not be expected to prevent routine generic competition at this stage.

How strong is the Percocet patent estate?

The patent estate is weak from a commercial exclusivity perspective. Its principal weaknesses are age, lack of differentiated delivery technology, and the availability of multiple approved generic products.

Patent-strength factor	Assessment
Composition-of-matter protection	Expired or commercially irrelevant
Formulation protection	No material current barrier identified
Method-of-use protection	Limited practical value for a broad analgesic indication
Manufacturing protection	Low barrier for established generic manufacturers
Orange Book blocking patents	No material current barrier identified
Lifecycle-management opportunity	Low without a new delivery or abuse-deterrent platform

A new abuse-deterrent or abuse-resistant oxycodone/acetaminophen product could create a different patent position, but that would be a new product strategy rather than protection for conventional Percocet.

Are there Paragraph IV challenges to Percocet?

Paragraph IV challenges are not a central current issue for Percocet. Generic oxycodone/acetaminophen products entered the market long ago, and the product is not operating behind a current patent barrier that would make a new ANDA challenge commercially significant.

Paragraph IV litigation is typically relevant when a generic applicant certifies that a listed patent is invalid, unenforceable, or not infringed. For a mature immediate-release combination with established generic competition, the greater commercial risks are usually:

• Price erosion.
• Supply interruptions.
• DEA quota limits.
• Manufacturing inspections.
• Controlled-substance compliance.
• Product recalls.
• Opioid-related litigation.

The absence of meaningful current Paragraph IV activity does not eliminate regulatory or supply-chain risk. It indicates that patent litigation is not the main determinant of market access.

What is the FDA regulatory status of Percocet?

Percocet is an FDA-approved prescription drug and a Schedule II controlled substance. Its labeling includes opioid class warnings and acetaminophen-related hepatotoxicity warnings.[1]

FDA regulation affects the product through several channels:

1. Controlled-substance scheduling and recordkeeping.
2. Manufacturing and distribution controls.
3. Opioid labeling and prescriber-risk requirements.
4. Prescription-drug-monitoring programs.
5. Postmarket adverse-event surveillance.
6. Enforcement against diversion and unlawful distribution.

FDA-approved generic products may use the reference product’s safety and efficacy findings through the ANDA pathway, subject to bioequivalence and other statutory requirements.[5]

What formulations are protected by Percocet patents?

The commercially relevant Percocet product is an immediate-release tablet. It does not have the type of formulation differentiation associated with extended-release oxycodone products, transdermal systems, injectable delivery, abuse-deterrent platforms, or complex drug-device combinations.

The main formulation issues are regulatory and safety-related rather than patent-driven:

• Acetaminophen concentration.
• Tablet strength.
• Immediate-release dissolution.
• Bioequivalence.
• Tablet appearance and labeling.
• Packaging and controlled-substance security.

Higher acetaminophen strengths have faced greater safety scrutiny. FDA’s 325 mg acetaminophen limit for prescription combination products reduced exposure per tablet and affected the formulation landscape for products in this category.[2]

Is there biosimilar risk for Percocet?

Biosimilar risk is not applicable. Percocet is a chemically synthesized small-molecule drug, not a biologic. The relevant competitive pathway is generic substitution through ANDAs, not biosimilar development under the Public Health Service Act.

This distinction matters commercially. A biosimilar market often involves interchangeability, manufacturing complexity, and biologic reference-product pricing. The Percocet market instead has:

• Multiple generic manufacturers.
• Conventional tablet manufacturing.
• Established bioequivalence methods.
• Low technical barriers.
• Strong pharmacy-substitution dynamics.

Which companies compete with Percocet?

Competition exists at three levels.

Branded and authorized products

The brand owner or marketer competes for residual brand prescriptions, institutional contracts, and prescriber recognition. Brand demand is limited because pharmacists and payers generally favor lower-cost generic equivalents.

Generic manufacturers

Generic oxycodone/acetaminophen suppliers have historically included major generic and specialty pharmaceutical manufacturers such as Endo, Teva, Mallinckrodt, Hikma, Amneal, and other approved ANDA holders. The active supplier set changes with product discontinuations, manufacturing constraints, enforcement actions, and business exits.

Therapeutic substitutes

Percocet competes with:

• Plain oxycodone.
• Hydrocodone/acetaminophen.
• Tramadol.
• Nonsteroidal anti-inflammatory drugs.
• Acetaminophen alone.
• Local anesthetics.
• Regional anesthesia.
• Non-pharmacologic pain treatment.

Hydrocodone/acetaminophen is the closest opioid-combination competitor in many acute-pain settings. Plain oxycodone may be selected when clinicians want to avoid additional acetaminophen exposure.

How does Percocet compare with hydrocodone/acetaminophen?

Factor	Percocet	Hydrocodone/acetaminophen
Opioid ingredient	Oxycodone	Hydrocodone
Acetaminophen component	Yes	Yes
Regulatory category	Schedule II	Schedule II
Common use	Acute moderate-to-severe pain	Acute pain, often moderate-to-severe
Generic competition	Extensive	Extensive
Patent barrier	No material current barrier	No material current barrier
Key safety concern	Opioid risk and acetaminophen liver toxicity	Same broad risks
Commercial differentiation	Limited	Limited

Product choice is influenced by prescriber preference, patient response, formularies, state rules, and hospital protocols. Neither product has a durable patent-based advantage.

What is the financial trajectory for Percocet?

Percocet’s financial trajectory is mature-to-declining in brand terms and commoditized in generic terms.

Brand economics

Brand revenue faces four structural pressures:

• Generic substitution.
• Reduced opioid prescribing.
• Payer preference for low-cost alternatives.
• Public and legal scrutiny of opioid promotion and distribution.

A public company generally cannot isolate Percocet revenue from its wider pain portfolio. As a result, there is no reliable public standalone revenue series for the brand. Revenue estimates from commercial databases may differ based on whether they measure prescriptions, manufacturer sales, pharmacy sales, or hospital purchases.

Generic economics

Generic oxycodone/acetaminophen sales can remain commercially meaningful despite low prices because of prescription volume. Profitability depends on:

• Manufacturing scale.
• API sourcing.
• DEA production quotas.
• Contract durability.
• Wholesaler access.
• Recall history.
• Regulatory compliance.
• Competition among approved suppliers.

The market can experience temporary price increases during shortages, but sustained pricing power is difficult to maintain when multiple manufacturers can supply equivalent products.

Owner-level financial exposure

For companies associated with Percocet or generic oxycodone products, financial exposure is broader than product revenue. It can include:

• Opioid settlement payments.
• Litigation defense expenses.
• Government investigations.
• Compliance-monitoring costs.
• Product-liability reserves.
• Bankruptcy or restructuring effects.
• Restrictions on opioid commercialization.

Endo International, a major U.S. specialty pharmaceutical company with opioid exposure, entered Chapter 11 proceedings in 2022 and completed its restructuring in 2024. Its financial history illustrates how opioid-related liabilities can dominate the value of mature pain products, even where the products retain prescription demand.[6]

What patent litigation affects Percocet?

Current Percocet economics are not principally shaped by patent litigation. The more important litigation environment concerns opioid marketing, distribution, public nuisance theories, personal injury, government claims, and compliance practices.

The National Prescription Opiate Litigation consolidated thousands of opioid-related federal cases in multidistrict litigation. Settlement frameworks have involved manufacturers, distributors, pharmacies, and other participants, with payment obligations and implementation terms varying by defendant and jurisdiction.[7]

Patent litigation would become more relevant only if a company introduced a differentiated successor product, such as:

• An abuse-deterrent formulation.
• A novel fixed-dose ratio.
• A long-acting delivery system.
• A tamper-resistant tablet.
• A combination with a new active ingredient.
• A product-device system with proprietary delivery technology.

Those products would have distinct patents and regulatory records from conventional Percocet.

Are there Percocet licensing deals?

No current, material standalone licensing transaction for conventional Percocet is central to the publicly reported market structure. The product is a legacy prescription drug with established approval and generic competition, not a newly licensed asset undergoing commercialization.

Potential commercial arrangements can include:

• Generic supply agreements.
• Authorized-generic arrangements.
• Hospital purchasing contracts.
• Wholesaler distribution agreements.
• Contract manufacturing.
• Settlement-related supply obligations.

These arrangements generally do not create durable patent exclusivity.

What generic launch scenarios exist for Percocet?

Because generic products are already established, future market events are more likely to involve supplier entry, exit, or re-entry than a first generic launch.

Base case

Generic supply remains available, brand share stays low, and prices remain pressured. Volume declines gradually with reduced opioid prescribing.

Shortage-driven upside

A manufacturing disruption, API shortage, quota restriction, or regulatory action removes suppliers from the market. Remaining manufacturers gain temporary volume and potentially higher prices.

Accelerated contraction

Prescribing restrictions, payer controls, hospital opioid-sparing programs, or substitution by non-opioid therapies reduce unit demand faster than expected.

Product-differentiation scenario

A new abuse-deterrent or lower-acetaminophen product gains formulary preference. This would create a new commercial segment but would not restore conventional Percocet’s historical exclusivity.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are regulatory and operational rather than patent-based. Suppliers must manage:

• DEA registration and quotas.
• Controlled-substance security.
• Good Manufacturing Practice compliance.
• Oxycodone API procurement.
• Acetaminophen quality controls.
• Content uniformity and dissolution testing.
• Serialization and supply-chain controls.
• Recall and pharmacovigilance systems.

The main risk is not whether a generic can be technically developed. It is whether the manufacturer can produce consistently, maintain regulatory compliance, obtain quota, and remain economically viable at generic prices.

What is the geographic coverage of the Percocet market?

The United States is the principal market addressed by this analysis because Percocet is a U.S. brand and its regulatory identity is closely tied to FDA and DEA requirements. Oxycodone/acetaminophen combinations are also marketed internationally under different brand names, strengths, labels, and controlled-substance rules.

Geographic performance varies with:

• National opioid policy.
• Reimbursement systems.
• Prescription monitoring.
• Hospital procurement.
• Controlled-substance scheduling.
• Cultural and clinical prescribing practices.
• Availability of alternative analgesics.

U.S. market conclusions should not be transferred directly to Canada, Europe, or other jurisdictions.

Key Takeaways

• Percocet is an established immediate-release oxycodone/acetaminophen product with no meaningful current patent exclusivity.
• Generic substitution, not patent litigation, determines most market access.
• The brand’s standalone revenue is not publicly separable from broader pain portfolios.
• The broader oxycodone/acetaminophen market is mature and under structural pressure from lower opioid prescribing and non-opioid alternatives.
• The product has no biosimilar risk because it is a small-molecule drug.
• Financial exposure includes opioid litigation, compliance costs, and supply-chain obligations.
• Manufacturing, DEA quota, API supply, and regulatory compliance are more important barriers than intellectual property.
• Future commercial upside would require a differentiated formulation or temporary generic supply disruption.

FAQs

Does Percocet still have patent protection?

No material current patent protection appears to support exclusivity for conventional immediate-release Percocet. Generic oxycodone/acetaminophen products have been available for many years.

Is Percocet still sold as a brand-name drug?

Brand availability can vary by supplier, distributor, pharmacy, and product presentation. The economically important market is generic oxycodone/acetaminophen, which supplies most prescriptions.

Can a generic company launch Percocet without a Paragraph IV lawsuit?

Generic companies already market oxycodone/acetaminophen products. A new ANDA applicant would evaluate Orange Book certifications and any listed patents, but current competition is not generally organized around a blocking Percocet patent.

Will opioids be replaced by non-opioid pain medicines?

Non-opioid therapies are gaining use in acute and chronic pain, but opioid demand remains in selected surgical, trauma, cancer, and severe-pain settings. The replacement effect is gradual and varies by indication.

What is the biggest investment risk for a Percocet-related business?

The largest risks are declining opioid volume, generic price erosion, controlled-substance compliance, supply disruptions, and opioid-related litigation or settlement obligations.

References

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

2. U.S. Food and Drug Administration. (2011). FDA limits acetaminophen in prescription combination products; requires labeling changes. FDA.

3. Centers for Disease Control and Prevention. (2024). U.S. opioid dispensing rate maps and data. CDC.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.

5. U.S. Food and Drug Administration. (2024). Abbreviated new drug application process. FDA.

6. Endo International plc. (2024). Annual report and restructuring disclosures. Endo International plc.

7. U.S. District Court, Northern District of Ohio. (2024). National prescription opiate litigation, MDL No. 2804. United States District Court.

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