List of Excipients in Branded Drug ENDOCET

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Generic Drugs Containing ENDOCET

Company	Ingredient	NDC	Excipient
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	CELLULOSE, MICROCRYSTALLINE
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	CROSCARMELLOSE SODIUM
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	CROSPOVIDONE
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	D&C YELLOW NO. 10
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	POVIDONE
STAT RX USA LLC	oxycodone and acetaminophen	16590-925	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in ENDOCET?

# Of NDCs	Excipient
10	CELLULOSE, MICROCRYSTALLINE
10	CROSCARMELLOSE SODIUM
10	CROSPOVIDONE
4	D&C YELLOW NO. 10
1	FD&C RED NO. 40
1	FD&C YELLOW NO. 6

Endocet Excipient Strategy and Commercial Opportunities for Oxycodone/Acetaminophen Tablets

Last updated: August 28, 2026

Endocet is an immediate-release combination of oxycodone hydrochloride and acetaminophen. Its commercial opportunity is largely generic and product-line based because the core formulation is mature, multiple manufacturers supply equivalent products, and the combination has limited formulation patent protection. The strongest opportunities are in reliable tablet manufacturing, differentiated dosage strengths, packaging, supply continuity, and compliant lifecycle management rather than broad composition-of-matter exclusivity.

What is Endocet and how is it formulated?

Endocet contains oxycodone hydrochloride, an opioid analgesic, and acetaminophen, a non-opioid analgesic and antipyretic. FDA labeling identifies the product as an immediate-release oral tablet available in multiple strengths, including 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg oxycodone hydrochloride/acetaminophen presentations. Product availability and manufacturer status have changed over time, so current commercial listings must be confirmed against FDA and National Library of Medicine records.[1][2]

The formulation objective is conventional:

• Rapid disintegration and dissolution
• Uniform distribution of a low-dose opioid throughout the tablet blend
• Adequate mechanical strength for coating, packaging, and transport
• Acceptable tablet weight and dimensions
• Stable acetaminophen and oxycodone content through shelf life
• Distinct visual identification by dosage strength
• Manufacturing controls that limit powder segregation and content variability

Endocet is not an extended-release or abuse-deterrent dosage form. Its commercial positioning is therefore based on immediate-release analgesic use and generic substitution, not on controlled-release technology.

What excipients are used in Endocet tablets?

Public product labeling identifies conventional tablet excipients. Depending on strength, manufacturer, and historical product version, the excipient system can include microcrystalline cellulose, croscarmellose sodium, povidone, stearic acid, magnesium stearate, hypromellose, titanium dioxide, and colorants.[1]

Excipient class	Typical function in oxycodone/acetaminophen tablets	Commercial relevance
Microcrystalline cellulose	Diluent and dry-binder	Supports direct compression and tablet strength
Croscarmellose sodium	Superdisintegrant	Promotes rapid tablet breakup
Povidone	Binder and granulation aid	Improves granule integrity and content uniformity
Magnesium stearate	Lubricant	Reduces ejection force and tooling friction
Stearic acid	Lubricant or processing aid	Can modify compaction and tablet surface properties
Hypromellose	Film-coating polymer	Improves appearance, handling, and identification
Titanium dioxide	Opacifier and pigment	Supports color uniformity and light protection
Approved colorants	Product identification	Distinguish dosage strengths and reduce dispensing errors

The exact excipient composition is not interchangeable from a regulatory perspective. An abbreviated new drug application must demonstrate pharmaceutical equivalence, bioequivalence, quality, and manufacturing control. A manufacturer can use a different excipient system, but the change can affect dissolution, stability, impurity formation, tablet hardness, and bioequivalence risk.

Why is excipient selection technically difficult?

The low oxycodone dose creates a content-uniformity challenge. Oxycodone hydrochloride must be distributed consistently through a blend containing a much larger quantity of acetaminophen and excipients. Particle-size mismatch, density differences, electrostatic charging, and overmixing can cause segregation.

Acetaminophen also has known manufacturing challenges. It can have poor flow and variable compactability depending on particle morphology and grade. A formulation may therefore require:

• Direct compression using a purpose-selected acetaminophen grade
• Wet or dry granulation
• Controlled lubricant concentration and blending time
• In-process blend uniformity testing
• Compression-force optimization
• Particle-size and bulk-density controls

The optimal strategy is usually a robust, low-complexity formula with a well-characterized excipient supply chain. Excessive excipient innovation can create regulatory and manufacturing risk without producing a meaningful commercial advantage.

What excipient strategy is best for an Endocet generic?

A practical strategy has four layers: quality, performance, manufacturing resilience, and market differentiation.

1. Use a conventional immediate-release platform

A standard matrix of diluent, superdisintegrant, binder, lubricant, and film coat generally offers the lowest development risk. The formulation should target rapid dissolution across the applicable FDA media and maintain tablet integrity during handling.

The product should avoid unnecessary hydrophobic excipient loading. Excess magnesium stearate, stearic acid, or over-lubrication can slow wetting and dissolution. This is especially relevant when the development target is a rapid immediate-release profile.

2. Control content uniformity through process design

The critical controls are not limited to excipient identity. They include:

• Oxycodone particle-size distribution
• Drug-to-excipient premix design
• Blend time
• Hopper residence time
• Feed-frame performance
• Tablet weight control
• Compression-force range
• In-process uniformity sampling

A premix or geometric dilution approach may reduce segregation risk. Roller compaction or wet granulation can improve flow, but each process adds scale-up, residual-moisture, and dissolution considerations.

3. Select excipients with supply-chain redundancy

A commercial formulation should avoid dependence on a single qualified supplier for microcrystalline cellulose, croscarmellose sodium, povidone, coating materials, or colorants. Dual sourcing can reduce interruption risk, but supplier changes require comparability controls and may trigger regulatory reporting.

For opioid products, supply continuity also depends on controlled-substance procurement, quota allocation, security, inventory controls, and diversion-prevention procedures. Excipient redundancy does not solve an active-ingredient supply constraint.

4. Use color and coating for operational differentiation

A film coat can distinguish 5/325, 7.5/325, and 10/325 strengths. This has value for pharmacy dispensing and medication-error reduction. However, colorants and coating systems should be selected with attention to:

• Global regulatory acceptability
• Light sensitivity
• Printing and debossing compatibility
• Visual differentiation from competing products
• Patient tolerability
• Supply availability

Color is a practical commercial tool, but it is rarely a durable patent barrier.

What FDA regulatory pathway applies to Endocet products?

A competing immediate-release oxycodone/acetaminophen tablet is generally developed through an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The applicant must demonstrate pharmaceutical equivalence and bioequivalence to the relevant reference product and meet current chemistry, manufacturing, and controls requirements.[3]

Key regulatory elements include:

Regulatory element	Endocet generic implication
Reference listed drug	Must identify the FDA-designated reference product
Dosage form	Immediate-release oral tablet
Active ingredients	Oxycodone hydrochloride and acetaminophen
Strength	Must match the approved reference strength
Route	Oral
Bioequivalence	Usually established under FDA’s product-specific guidance and applicable study framework
Dissolution	Must support equivalence and batch release
Labeling	Must conform to approved labeling, including opioid warnings
Controlled substance	Oxycodone products are subject to DEA controls
Risk management	Opioid prescribing, dispensing, storage, and distribution controls apply

The acetaminophen component creates a separate safety issue. Labeling must communicate the risk of severe liver injury from excessive total daily acetaminophen exposure, including use with other acetaminophen-containing products.[1]

What is the Orange Book status of Endocet?

Endocet has been subject to substantial generic competition, and the commercial value of the brand is not based on an active exclusivity position comparable to a recently launched innovative drug. FDA Orange Book records should be used to verify current NDA status, listed patents, exclusivity, and approved strengths.[4]

For a mature immediate-release combination product, the expected Orange Book profile is commercially important in three areas:

1. Whether a current reference listed drug remains active.
2. Whether any patents are listed against the relevant strength or dosage form.
3. Whether the product is eligible for ANDA referencing and substitution in the target market.

A generic applicant should not assume that an old brand name, discontinued package, or historical labeling creates continuing patent protection. Patent listings, NDA status, and product availability must be evaluated separately.

What patents protect Endocet and its formulation?

The principal active ingredients, oxycodone and acetaminophen, are long-established compounds. Broad composition-of-matter protection is expired. The immediate-release combination also lacks the technological profile associated with newer formulation patents, such as abuse-deterrent matrices, multiparticulate delivery, osmotic systems, or long-acting release mechanisms.

Potentially relevant IP categories include:

• Combination-composition patents
• Tablet-coating patents
• Manufacturing-process patents
• Crystal-form or particle-engineering patents
• Abuse-deterrent formulations
• Method-of-use patents
• Packaging and identification systems

For a conventional Endocet-equivalent tablet, the practical patent risk is likely to be lower than for extended-release oxycodone products. That conclusion does not eliminate the need for a current patent search. FDA Orange Book listings, USPTO records, ANDA litigation records, and state-specific substitution rules should be reviewed before launch.[4][5]

When does Endocet lose exclusivity and what is the generic entry risk?

Endocet is already exposed to generic competition in the United States. Generic entry risk is therefore not a future cliff tied to a single upcoming expiration date. It is an established market condition.

Risk factor	Assessment
Composition-of-matter expiry	Low barrier; active ingredients are old
Immediate-release formulation patents	Likely limited for conventional products
Orange Book patent risk	Requires current record-by-record verification
Paragraph IV exposure	More relevant to any later-listed patent than to the basic drug combination
Generic substitution	High
Price erosion	High in ordinary wholesale channels
Supply disruption opportunity	Moderate to high during shortages or manufacturer exits
Brand premium	Limited unless supported by contracting, availability, or differentiated packaging

Paragraph IV challenges may arise if an ANDA applicant believes a listed patent is invalid, unenforceable, or will not be infringed. For a mature product with no meaningful current listed patent estate, the main entry path may instead involve a Paragraph III certification or a certification that no relevant patent is listed.[3][4]

What commercial opportunities exist for Endocet excipients?

The strongest opportunities are operational and portfolio-based rather than premium branded reformulation.

Reliable generic supply

Manufacturers can compete through dependable availability of common strengths, particularly 5/325 mg and 10/325 mg tablets. Hospitals, wholesalers, and group purchasing organizations may value continuity when competing suppliers experience quota, quality, or manufacturing problems.

Multi-strength portfolio manufacturing

A shared excipient platform across strengths can reduce validation and inventory complexity. Dosage-strength differentiation can be achieved through tablet weight, color, imprint, or coating while preserving common process parameters.

Excipient and process optimization

A supplier or contract development organization could offer:

• Direct-compression acetaminophen grades
• Low-segregation premixes
• Continuous manufacturing platforms
• High-throughput coating systems
• Robust disintegration and dissolution profiles
• Dual-sourced excipient packages
• Stability packages designed for hot and humid markets

These offerings are more defensible when supported by process know-how, validated scale-up, and consistent supply than by a single novel excipient.

Regional and export markets

Oxycodone regulatory controls vary sharply by country. Export opportunities depend on narcotics quotas, import permits, controlled-substance rules, local labeling, and demand for combination analgesics. A formulation optimized for the United States may require different colorants, packaging, tablet markings, or regulatory documentation in other jurisdictions.

Packaging and diversion control

Unit-dose blister packs, tamper-evident cartons, serialized packaging, and pharmacy-oriented pack sizes can create commercial differentiation. Packaging does not replace controlled-substance compliance, but it can improve inventory control and reduce handling risk.

How does Endocet compare with competing oxycodone products?

Product category	Formulation profile	Patent and commercial position
Endocet-type immediate-release tablet	Oxycodone/acetaminophen, conventional tablet	Highly genericized; price and supply competition
Generic oxycodone/acetaminophen	Same active ingredients and immediate-release profile	Main competitive segment
Roxicodone-type oxycodone tablet	Oxycodone without acetaminophen	Useful where acetaminophen exposure is undesirable
Extended-release oxycodone	Controlled-release oxycodone	Greater formulation complexity and historically stronger patent exposure
Abuse-deterrent oxycodone	Specialized tamper-resistant technology	Higher development cost and potentially stronger IP barriers

Endocet-type products compete primarily on unit cost, availability, wholesaler access, quality history, and contract coverage. They do not generally compete through a novel delivery system.

What litigation and settlement issues affect Endocet?

The major legal exposure around oxycodone products has included opioid marketing, distribution, controlled-substance compliance, and public-health litigation. These matters are distinct from patent litigation over an immediate-release Endocet-equivalent tablet.

A commercial diligence review should separate:

• Patent infringement litigation
• ANDA Paragraph IV litigation
• Product-liability cases
• Government enforcement
• Controlled-substance distribution actions
• Opioid settlement obligations
• Recall and manufacturing-quality events

Settlement agreements involving opioid manufacturers may affect corporate liability, distribution practices, or market access, but they do not automatically create formulation exclusivity for Endocet. Current litigation and settlement terms must be checked against court dockets, FDA notices, and company disclosures.[6]

How strong is the Endocet patent estate?

For the conventional immediate-release combination, the patent estate is commercially weak relative to newer opioid delivery technologies. The main barriers are regulatory, operational, and controlled-substance related.

Estate component	Relative strength
Active-ingredient patents	Very low
Conventional tablet composition	Low
Immediate-release formulation claims	Low to moderate, depending on specific claims
Manufacturing know-how	Moderate if process capability is difficult to replicate
Abuse-deterrent technology	Not central to standard Endocet
Regulatory exclusivity	Limited for a mature product
Supply and compliance barriers	Moderate to high
Brand and contracting barriers	Variable

The most defensible commercial position is a compliant, low-cost, consistently available product supported by manufacturing reliability and supply-chain control.

Key Takeaways

• Endocet is an immediate-release oxycodone hydrochloride/acetaminophen tablet with a conventional excipient architecture.
• Relevant excipients include microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, stearic acid, hypromellose, titanium dioxide, and colorants, subject to product-specific variation.
• The main technical risks are oxycodone content uniformity, acetaminophen compactability, blend segregation, lubrication effects, and dissolution performance.
• The product is already exposed to generic competition, so commercial value depends on supply reliability, cost, contracting, and packaging.
• Broad active-ingredient patent protection is expired. Current Orange Book entries and patent litigation must be checked by product and strength.
• Excipient innovation has greater value when it improves manufacturability, stability, dissolution consistency, or supply resilience.
• Opioid controls, quota management, diversion prevention, and acetaminophen safety labeling are central commercial constraints.
• Standard immediate-release Endocet products have a weaker patent position than extended-release or abuse-deterrent oxycodone formulations.

FAQs

Can a manufacturer change Endocet excipients in an ANDA?

Yes. A different excipient system may be used if the applicant demonstrates pharmaceutical equivalence, bioequivalence, acceptable dissolution, stability, quality, and manufacturing control.

Is an Endocet generic required to contain the same colorants?

Not necessarily. Colorants may differ if the product satisfies FDA requirements and does not create labeling, identification, safety, or equivalence problems.

Can an excipient create patent protection for an Endocet generic?

Potentially, but only if the excipient combination or manufacturing process supports valid, enforceable claims with commercial scope. Conventional excipients alone rarely create a strong barrier.

Is oxycodone/acetaminophen subject to biosimilar competition?

No. Endocet is a small-molecule drug, not a biologic. Competition occurs through generic-drug pathways rather than biosimilar approval.

What is the most attractive commercial niche for an Endocet-equivalent product?

The strongest niche is dependable supply of high-demand strengths, supported by efficient manufacturing, dual-sourced excipients, compliant controlled-substance operations, and pharmacy-friendly packaging.

References

1. DailyMed. (n.d.). Endocet: Oxycodone hydrochloride and acetaminophen tablet, prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (2024). Abbreviated new drug application (ANDA) process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

4. U.S. Food and Drug Administration. (n.d.). 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

5. U.S. Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/

6. U.S. Department of Justice. (n.d.). Opioid-related enforcement and litigation resources. https://www.justice.gov/ opioids