List of Excipients in Branded Drug OXYMORPHONE HYDROCHLORIDE

Generic Drugs Containing OXYMORPHONE HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	oxymorphone hydrochloride	0054-0283	CELLULOSE, MICROCRYSTALLINE
Hikma Pharmaceuticals USA Inc	oxymorphone hydrochloride	0054-0283	MAGNESIUM STEARATE
Hikma Pharmaceuticals USA Inc	oxymorphone hydrochloride	0054-0283	STARCH, CORN
Amneal Pharmaceuticals of New York LLC	oxymorphone hydrochloride	0115-1231	ALUMINUM OXIDE
Amneal Pharmaceuticals of New York LLC	oxymorphone hydrochloride	0115-1231	CELLULOSE, MICROCRYSTALLINE

What are the Most Frequently-Used Excipients in OXYMORPHONE HYDROCHLORIDE?

# Of NDCs	Excipient
4	ALUMINUM OXIDE
4	ANHYDROUS LACTOSE
11	CELLULOSE, MICROCRYSTALLINE
2	D&C RED NO. 27
2	D&C RED NO. 30

Oxymorphone Hydrochloride Excipient Strategy and Commercial Opportunities

Last updated: August 23, 2026

Oxymorphone hydrochloride is an off-patent, highly potent opioid with limited branded commercial protection and elevated regulatory risk. The strongest opportunities are in hospital injection supply, differentiated immediate-release tablets, carefully engineered extended-release formulations, and excipient platforms that support tamper resistance without creating unacceptable abuse-deterrence claims. Commercial success depends more on manufacturing reliability, controlled-substance compliance, bioequivalence, and supply security than on basic API differentiation.

What dosage forms use oxymorphone hydrochloride?

Oxymorphone hydrochloride has been marketed in oral immediate-release tablets, oral extended-release tablets, and injectable dosage forms.

Dosage form	Primary use	Excipient priority	Commercial position
Immediate-release tablet	Acute or breakthrough pain	Low-cost compression, rapid dissolution, physical stability	Generic commodity market
Extended-release tablet	Around-the-clock severe pain	Release-rate control, alcohol resistance, crush resistance	Limited market after branded withdrawal
Injection	Hospital and procedural analgesia	Sterility, low particulate burden, pH control, container compatibility	Niche hospital and institutional opportunity
Oral liquid	Potential specialized dosing	Solubility, preservative system, dosing accuracy, diversion control	High regulatory and abuse risk

Oxymorphone hydrochloride is a small-molecule active pharmaceutical ingredient, so biosimilar competition is not applicable. Competition occurs through abbreviated new drug applications, authorized generics, hospital contracts, and potential 505(b)(2) products.

What is the FDA regulatory status of oxymorphone hydrochloride?

FDA-approved oxymorphone products are Schedule II opioid products. FDA approved Opana ER, an extended-release oxymorphone hydrochloride product, but requested its withdrawal in 2017 because the agency determined that the product's benefits no longer outweighed its risks after evaluating postmarketing evidence related to abuse by injection.[1]

The withdrawal was based on public-health risk, not a finding that oxymorphone hydrochloride could no longer be used in all dosage forms. Immediate-release tablets and injectable products remain subject to the standard opioid regulatory framework, including abuse-risk controls, restricted distribution considerations, postmarketing obligations, and controlled-substance manufacturing requirements.

FDA regulatory considerations

A sponsor developing an oxymorphone hydrochloride product must address:

• FDA approval through an ANDA, 505(b)(2) application, or supplemental application;
• Schedule II controlled-substance registration and quota requirements;
• opioid labeling and medication-guide requirements;
• abuse-deterrent labeling standards, if applicable;
• extractables and leachables from packaging;
• dissolution testing across pH conditions;
• alcohol-induced dose-dumping studies for extended-release products;
• tablet manipulation studies, including crushing, grinding, heating, and solvent extraction;
• stability under controlled storage and distribution conditions.

FDA's abuse-deterrent opioid guidance makes clear that physical manipulation resistance alone does not establish abuse-deterrent labeling. Sponsors must generate evidence against the relevant abuse routes and meet FDA's labeling standards.[2]

When does oxymorphone hydrochloride lose exclusivity?

Oxymorphone hydrochloride has no meaningful remaining active-ingredient exclusivity. The molecule and conventional oral dosage forms are old products, and generic competition has been established.

The commercial distinction is between:

1. active pharmaceutical ingredient exclusivity, which is effectively exhausted;
2. product-specific patents, which may protect particular release technologies or formulations;
3. regulatory exclusivity, which may arise for a new 505(b)(2) product;
4. manufacturing and supply advantages, which are not statutory exclusivity but can support market access.

Opana ER's commercial protection was associated with formulation and product patents rather than a new chemical entity period. Relevant patent protection has largely expired or become commercially immaterial following withdrawal of the branded product. Current patent analysis should rely on the FDA Orange Book and the USPTO Patent Center for the specific product and applicant because patent listings can differ by dosage form, strength, and product status.[3,4]

Orange Book status

The Orange Book is the controlling source for FDA-listed patents and exclusivity associated with approved drug products. For generic oxymorphone hydrochloride tablets, the principal commercial barrier is generally not an active pioneer patent but the requirement to demonstrate pharmaceutical equivalence and bioequivalence while complying with opioid-specific regulatory controls.[3]

A sponsor should review:

• listed patents for each oxymorphone hydrochloride strength;
• whether a listed patent remains active;
• pediatric exclusivity attached to any listed patent;
• whether the reference product has been withdrawn for reasons of safety or effectiveness;
• whether a proposed generic relies on a discontinued reference product;
• whether an ANDA applicant must address Paragraph IV certifications.

What excipients are suitable for oxymorphone hydrochloride immediate-release tablets?

The immediate-release opportunity is primarily a cost, quality, and supply-chain exercise. The target profile is rapid release, low tablet weight, strong mechanical integrity, and consistent content uniformity at low dose strengths.

Recommended excipient architecture

A conventional immediate-release formulation may use:

Function	Candidate excipient classes	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, mannitol, dibasic calcium phosphate	Supports tablet weight and content uniformity
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Crospovidone, croscarmellose sodium, sodium starch glycolate	Controls tablet breakup and dissolution
Glidant	Colloidal silicon dioxide	Improves powder flow
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces sticking and ejection force
Film coat	Hypromellose, polyethylene glycol, titanium dioxide or approved colorants	Supports identification, handling, and light protection

A direct-compression formulation can reduce manufacturing steps, but low-dose uniformity, powder segregation, and lubricant sensitivity require close control. Wet granulation may improve content uniformity and compressibility, but it adds drying, residual-moisture, and process-validation burdens.

Excipient selection risks

Oxymorphone hydrochloride is potent, so content uniformity is a central development risk even when the active load is low. The formulation should be evaluated for:

• segregation during blending and transfer;
• electrostatic charging;
• adsorption to processing equipment;
• sensitivity to over-lubrication;
• dissolution changes after scale-up;
• assay variability across tablet compression runs;
• interaction with reducing sugars, moisture, or reactive impurities.

A low-moisture, direct-compression platform may be commercially attractive if it delivers robust content uniformity and avoids complex granulation equipment.

What formulations are protected by oxymorphone hydrochloride patents?

The strongest historical patent value has been in modified-release and abuse-deterrent formulation technology, not in ordinary immediate-release tablets.

Extended-release matrix formulations

Potential patentable elements include:

• hydrophilic polymer concentration and viscosity grade;
• combinations of hypromellose with hydrophobic waxes or fatty materials;
• compression force and tablet porosity;
• drug-release profiles across physiological pH;
• resistance to alcohol-induced dose dumping;
• particle-size distribution of oxymorphone hydrochloride;
• coating systems that control hydration and erosion;
• manufacturing processes that create a defined release matrix.

A generic extended-release formulation must match the reference product's release behavior, often across multiple dissolution methods and media. It may also need to address food effects and alcohol interaction.

Abuse-deterrent formulations

Abuse-deterrent design may use:

• hard, high-compression tablets;
• gelling polymers that form a viscous mass in water;
• high-viscosity extraction-resistant matrices;
• polymer networks that limit powder formation;
• coating systems that resist crushing;
• combinations that reduce opioid release after manipulation.

The commercial and regulatory threshold is high. A formulation that is difficult to crush may still permit extraction, injection, or inhalation. FDA's abuse-deterrent framework separates laboratory manipulation data, pharmacokinetic studies, and postmarketing evidence.[2]

Patent claims may cover excipient ratios, processing conditions, performance thresholds, or a combination of formulation and abuse-resistance characteristics. Broad claims around generic polymers are vulnerable to prior-art challenges. Narrow claims tied to specific release and manipulation data may be more defensible but harder to design around.

How strong is the oxymorphone hydrochloride patent estate?

The estate is weak for conventional immediate-release products and potentially stronger for specialized extended-release or abuse-deterrent formulations.

Patent category	Expected strength	Main vulnerability
Oxymorphone hydrochloride composition of matter	Low	Historical expiration
Conventional immediate-release tablet	Low	Routine formulation practices and generic prior art
Hydrophilic extended-release matrix	Moderate	Obviousness and design-around risk
Abuse-deterrent tablet	Moderate to high for narrow claims	Prior art, enablement, and clinical-label limitations
Manufacturing process	Moderate	Process substitution and limited infringement visibility
Packaging or dosing system	Low to moderate	Easy substitution unless integrated with product performance

The most defensible portfolio would combine formulation claims, dissolution-profile claims, manipulation-resistance claims, manufacturing claims, and, where legally supportable, method-of-use claims. A single broad excipient claim is unlikely to provide durable protection in a mature opioid market.

What commercial opportunities exist for oxymorphone hydrochloride?

Hospital injectable products

Injectable oxymorphone hydrochloride has the clearest niche opportunity. Hospitals value:

• dependable API supply;
• sterile manufacturing capacity;
• low particulate levels;
• container-closure compatibility;
• reliable fill-finish;
• short lead times;
• contractual supply continuity.

The market is narrower than oral analgesics but may be less exposed to retail generic substitution if a supplier qualifies for institutional contracts. The main barriers are sterile-facility validation, controlled-substance security, inspection readiness, and pharmacopoeial compliance.

Differentiated immediate-release tablets

An immediate-release product can compete through:

• multiple strengths;
• low tablet weight;
• improved content uniformity;
• simplified manufacturing;
• scored tablets, where permitted by labeling and performance data;
• color and imprint differentiation;
• reliable supply to hospitals and specialty pharmacies.

This is a low-margin segment. Excipient innovation has value only if it reduces manufacturing failures, improves stability, or supports a differentiated regulatory pathway.

Extended-release products

An extended-release product could address a limited market if it offers a clinically and regulatorily credible profile. Commercial positioning would require:

• robust tamper-resistance data;
• low risk of alcohol-induced dose dumping;
• predictable food-effect behavior;
• tablet integrity after manipulation;
• clear differentiation from withdrawn Opana ER;
• a risk-management and postmarketing strategy acceptable to FDA.

A sponsor should not assume that an abuse-deterrent formulation will restore the former branded market. The FDA withdrawal materially changed the risk profile for any oxymorphone ER investment.[1]

Excipient and technology licensing

The most transferable opportunity may be a platform license rather than an oxymorphone-only product. Relevant assets include:

• crush-resistant matrix technology;
• injectable excipient and container systems;
• low-dose content-uniformity platforms;
• alcohol-resistant extended-release matrices;
• controlled-substance manufacturing and serialization systems.

A licensor can target other opioids and central nervous system products, increasing the addressable market. The license should define ownership of formulation improvements, process changes, regulatory data, and jurisdiction-specific patent rights.

Which companies are challenging oxymorphone hydrochloride products?

Competition is primarily from generic-drug manufacturers and contract manufacturers rather than from branded originators. Typical competitive groups include:

• established ANDA applicants with opioid manufacturing capacity;
• specialty generic companies;
• sterile injectable manufacturers;
• API suppliers with controlled-substance registrations;
• contract development and manufacturing organizations;
• licensors of abuse-deterrent delivery platforms.

Publicly identifying current challengers requires a product-specific review of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, ANDA records, federal litigation dockets, and current commercial supply contracts. The market should be assessed by dosage form and strength because an applicant may compete in one segment without supplying the others.

What Paragraph IV challenges and litigation affect oxymorphone hydrochloride?

Paragraph IV litigation is most relevant to active patents listed against a reference product. For conventional oxymorphone hydrochloride immediate-release products, the key risk is usually regulatory and operational rather than pioneer-patent litigation.

A Paragraph IV strategy may arise where a sponsor seeks approval for:

• an extended-release product with a still-listed formulation patent;
• an abuse-deterrent formulation;
• a 505(b)(2) product that relies on a reference product but changes excipients, release characteristics, or route of administration.

The standard litigation risks include:

• infringement based on dissolution or formulation claims;
• obviousness challenges against polymer combinations;
• noninfringement based on different excipient ratios;
• patent-listing disputes;
• 30-month-stay exposure under the Hatch-Waxman framework;
• supply interruption if an injunction is imposed.

Any investment decision should distinguish an active case from historical litigation involving Opana ER. Historical settlements or licenses do not automatically apply to a new oxymorphone formulation, a new applicant, or a different jurisdiction.

What generic launch scenarios exist for oxymorphone hydrochloride?

Immediate-release launch

The most practical scenario is an ANDA for one or more tablet strengths. The launch depends on reference-product availability, bioequivalence, manufacturing readiness, and market supply conditions. Price erosion is likely because the active ingredient is mature and multiple generic manufacturers can compete.

Injectable launch

A sterile injectable launch can produce better pricing than oral tablets if there are few qualified suppliers. The trade-off is higher capital expenditure, longer validation, and greater regulatory exposure.

Extended-release launch

An extended-release launch has the highest technical and regulatory burden. It may require a complex generic pathway, formulation-specific patent analysis, and extensive manipulation and dissolution testing. The addressable market is uncertain because of Opana ER's withdrawal and continuing opioid scrutiny.

505(b)(2) launch

A 505(b)(2) strategy may be justified by a new dosage form, dosing system, or formulation with clinical or administration advantages. The pathway is more expensive than an ANDA but may support limited exclusivity and formulation patents. It does not eliminate controlled-substance obligations.

How does oxymorphone hydrochloride compare with competing opioid products?

Product category	Relative development burden	Excipient differentiation	Commercial outlook
Oxycodone IR	Low to moderate	Limited	Larger established generic market
Hydromorphone IR	Low to moderate	Limited	Hospital and specialty demand
Oxymorphone IR	Moderate	Limited	Smaller, supply-sensitive niche
Extended-release opioids	High	Significant	Strong regulatory and safety constraints
Non-opioid analgesics	Variable	Often broader	Lower controlled-substance burden

Oxymorphone's potency can create a small-tablet and low-dose uniformity advantage, but it also increases diversion, occupational exposure, and regulatory scrutiny. Compared with oxycodone and hydromorphone, the market is narrower and more sensitive to product withdrawal history.

What manufacturing and intellectual-property barriers matter most?

The principal manufacturing barriers are:

1. controlled-substance quota and inventory management;
2. API supply continuity;
3. low-dose blend uniformity;
4. tablet-strength consistency;
5. sterile fill-finish capability for injection;
6. validated analytical methods;
7. secure handling and reconciliation;
8. scale-up without dissolution drift.

The principal IP barriers are:

• formulation claims covering release kinetics;
• abuse-deterrent matrix claims;
• process patents that require specific granulation or compression conditions;
• patents covering excipient combinations;
• method-of-use claims tied to dosing or patient populations;
• packaging or delivery-system claims.

Geographic coverage is likely to be strongest in the United States for FDA-regulated products, with separate freedom-to-operate analysis required in Canada, Europe, Japan, China, and other regulated markets. Patent expiry, opioid scheduling, reference-product status, and local controlled-substance rules vary by jurisdiction.

What is the revenue exposure and investment case?

Revenue exposure is concentrated in three areas:

• oral generic tablets, which offer volume but limited margin;
• hospital injection, which offers smaller volume and potentially better pricing;
• proprietary extended-release or abuse-deterrent technology, which offers the greatest upside but the highest probability of regulatory and commercial failure.

A practical portfolio strategy would prioritize a low-cost immediate-release or injectable product to establish supply capability, then evaluate a broader abuse-deterrent platform applicable to multiple opioids. An oxymorphone-only extended-release investment has a weaker risk-adjusted profile unless supported by clear clinical differentiation, strong patent claims, and a committed commercial partner.

Key Takeaways

• Oxymorphone hydrochloride is an off-patent small-molecule opioid with no biosimilar pathway.
• Immediate-release tablets are primarily a manufacturing and supply opportunity, not a strong patent opportunity.
• Injectable products may offer the best niche economics if sterile capacity and hospital contracting are available.
• Extended-release development carries substantial regulatory risk after FDA requested withdrawal of Opana ER.
• Excipient value is highest in low-dose uniformity, sterile formulation, controlled release, and abuse-deterrent technology.
• Patent portfolios should combine formulation, process, dissolution, and manipulation-resistance claims.
• Generic competition, controlled-substance compliance, and supply reliability are more important than legacy composition patents.
• A platform license covering multiple opioids is commercially stronger than an oxymorphone-only formulation license.

FAQs

Can oxymorphone hydrochloride be formulated as an oral solution?

Yes, but an oral solution would face elevated diversion, dosing-error, child-exposure, preservative, packaging, and controlled-substance risks. A liquid product would need a strong regulatory and commercial rationale.

Which excipient is best for oxymorphone hydrochloride extended release?

No single excipient is universally preferred. Hydrophilic hypromellose matrices are common development starting points, but polymer grade, concentration, compression force, tablet porosity, and coating design determine the release profile.

Is an abuse-deterrent oxymorphone tablet automatically patentable?

No. Patentability depends on novelty, nonobviousness, enablement, and claim scope. A generic polymer combination may be unpatentable unless the formulation produces a defined and unexpected performance result.

Does FDA's Opana ER withdrawal prohibit new oxymorphone extended-release products?

No. It materially raises the regulatory and commercial burden. A new product would need an approval strategy that addresses the safety concerns underlying the withdrawal and supports its proposed labeling.

Are excipient suppliers exposed to opioid product liability?

Potentially. Exposure depends on the supplier's role, specifications, quality systems, contractual allocation of responsibility, and applicable product-liability law. Suppliers should control change management, traceability, and customer qualification.

References

1. U.S. Food and Drug Administration. (2017). FDA requests removal of Opana ER for risks related to abuse. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-opana-er-risks-related-abuse

2. U.S. Food and Drug Administration. (2015). Abuse-deterrent opioids: Evaluation and labeling guidance for industry. https://www.fda.gov/media/84819/download

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

4. United States Patent and Trademark Office. (2024). Patent Center. https://patentcenter.uspto.gov/

5. U.S. Food and Drug Administration. (2023). Drug development and drug interactions: Table of substrates, inhibitors and inducers. https://www.fda.gov/

6. U.S. Food and Drug Administration. (2022). Abbreviated new drug application submissions: Content and format guidance for industry. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs