List of Excipients in Branded Drug LORTAB

Generic Drugs Containing LORTAB

Company	Ingredient	NDC	Excipient
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	CELLULOSE, MICROCRYSTALLINE
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	CROSCARMELLOSE SODIUM
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	CROSPOVIDONE
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	D&C YELLOW NO. 10
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	FD&C BLUE NO. 1
STAT RX USA LLC	hydrocodone bitartrate and acetaminophen	16590-636	POVIDONE

What are the Most Frequently-Used Excipients in LORTAB?

# Of NDCs	Excipient
3	ANHYDROUS CITRIC ACID
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	CROSPOVIDONE
2	D&C RED NO. 33
2	D&C YELLOW NO. 10

Lortab Excipient Strategy and Commercial Opportunities for Hydrocodone-Acetaminophen Tablets

Last updated: August 22, 2026

Lortab is a discontinued brand of hydrocodone bitartrate and acetaminophen, historically marketed in multiple immediate-release tablet strengths. The active pharmaceutical ingredient combination has no meaningful biologic exclusivity or current brand-led patent barrier in the United States. Commercial opportunities therefore center on generic ANDA products, abuse-deterrent or tamper-resistant formulations, lower-acetaminophen products, pediatric or geriatric usability, and differentiated manufacturing economics.

The strongest excipient strategy is not simple substitution. It is a formulation program that improves dose uniformity, tablet robustness, dissolution control, palatability, manufacturability, and resistance to misuse while avoiding excipients that create new regulatory or safety concerns.

What is Lortab and what products did it contain?

Lortab contained hydrocodone bitartrate and acetaminophen in immediate-release oral tablets. Historical strengths included:

Historical strength	Hydrocodone bitartrate	Acetaminophen
Lortab 2.5/500	2.5 mg	500 mg
Lortab 5/500	5 mg	500 mg
Lortab 7.5/500	7.5 mg	500 mg
Lortab 10/500	10 mg	500 mg

The product was listed under FDA NDA 018651. Lortab and similar hydrocodone-acetaminophen products were later affected by FDA action limiting acetaminophen content in prescription combination products to no more than 325 mg per dosage unit. FDA’s action responded to the risk of severe liver injury from excessive acetaminophen exposure.[1]

Current commercial products generally use the hydrocodone-acetaminophen combination at a maximum acetaminophen strength of 325 mg per tablet. Historical 500 mg acetaminophen products are commercially obsolete in the U.S. prescription market.

What is the current FDA and Orange Book status of Lortab?

Lortab is not a current growth brand. The original branded product has been discontinued, while generic hydrocodone bitartrate and acetaminophen tablets remain available through ANDA-approved products and other authorized prescription products.

The relevant regulatory position is:

Issue	Current commercial assessment
Reference brand	Lortab
Active ingredients	Hydrocodone bitartrate and acetaminophen
Dosage form	Immediate-release tablet
FDA pathway for standard generic	ANDA under section 505(j)
Controlled-substance status	Schedule II opioid
Biosimilar pathway	Not applicable
Historical brand patent value	Low or exhausted
Current opportunity	Generic supply, differentiated formulation, manufacturing, and specialty distribution
Principal regulatory risks	Opioid controls, acetaminophen hepatotoxicity, abuse potential, supply quotas, and controlled-substance compliance

The FDA Orange Book identifies approved drug products and listed patents or exclusivity information. It does not create a commercial right to revive a discontinued brand or establish market demand for a particular historical formulation.[2]

What patents protect Lortab and when did exclusivity expire?

Lortab’s principal commercial exclusivity is not currently patent-driven. The product was approved decades ago, and the core combination of hydrocodone and acetaminophen is an established immediate-release product concept. Any original composition, formulation, or method-of-use patents associated with the historical product would generally have expired long before the current market.

A modern applicant should distinguish between three categories of intellectual property:

IP category	Relevance to Lortab opportunity
Original hydrocodone-acetaminophen combination patents	Generally expired or commercially irrelevant
New excipient or manufacturing patents	Potentially available if they provide a non-obvious technical benefit
Abuse-deterrent formulation patents	Potentially valuable, but require meaningful performance data and market adoption
Label or method-of-use patents	Limited value for a conventional pain indication
Trade secrets	Important for granulation, compression, coating, analytical control, and scale-up

A reformulated product may obtain patent protection for a specific excipient architecture, manufacturing process, particle morphology, coating system, or abuse-deterrent performance profile. A patent claiming only a routine excipient substitution is vulnerable to novelty and obviousness challenges.

Are there active Paragraph IV challenges to Lortab?

Paragraph IV litigation is unlikely to be a central issue for the historical Lortab brand. Generic hydrocodone-acetaminophen products have been marketed for many years, and the commercial market is not dependent on a pending challenge to an active Lortab patent estate.

A new applicant using the conventional immediate-release formula would normally pursue an ANDA with paragraph I, II, or III certification, depending on the Orange Book record and the status of listed patents. A paragraph IV certification would matter only if an unexpired, relevant patent were listed against the applicable reference product.

What excipients are suitable for a Lortab tablet?

A standard immediate-release Lortab-type tablet requires excipients that support high-dose acetaminophen loading, low-dose hydrocodone uniformity, tablet strength, rapid release, and reliable scale-up.

Recommended excipient platform

Formulation function	Candidate excipients	Commercial rationale
Diluent	Microcrystalline cellulose, lactose monohydrate, dibasic calcium phosphate	Supports compressibility and tablet mass control
Binder	Povidone, copovidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule strength and content uniformity
Disintegrant	Crospovidone, croscarmellose sodium, sodium starch glycolate	Supports rapid tablet breakup and dissolution
Glidant	Colloidal silicon dioxide	Improves powder flow and die filling
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces sticking and ejection force
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, iron oxides	Supports appearance, swallowability, identification, and light protection
Taste-control system	Film coating, ion-exchange resin, polymer matrix	Relevant to abuse deterrence and accidental exposure control

Microcrystalline cellulose and crospovidone provide a practical starting point for direct compression or dry granulation. Wet granulation may be preferable when acetaminophen loading, hydrocodone distribution, or powder segregation creates content-uniformity risk.

The excipient selection must account for acetaminophen’s high concentration relative to hydrocodone. Hydrocodone is present at a low dose, so segregation and blend uniformity are more important than total tablet weight alone. Ordered mixing, geometric dilution, carrier-based premixes, or controlled wet granulation can reduce low-dose active variability.

What formulation patents could protect a new Lortab product?

A commercially defensible formulation patent should claim a measurable technical result. Potential claim areas include:

1. A controlled-release or abuse-deterrent matrix that limits opioid extraction while preserving therapeutic dissolution.
2. A coating that reduces crushing, powder generation, or solvent extraction.
3. A low-acetaminophen tablet with improved hydrocodone uniformity.
4. A multiparticulate formulation that separates hydrocodone and acetaminophen release profiles.
5. A manufacturing process that reduces segregation during high-speed compression.
6. A moisture-protective package and coating system that improves stability.
7. A formulation that reduces tablet size without compromising hardness or dissolution.
8. A taste-masked dosage form for patients who cannot swallow conventional tablets.

The strongest patent position would combine composition and process claims. Composition claims can be designed around polymer ratios, particle-size distributions, coating weight gain, extraction resistance, and dissolution limits. Process claims can cover granulation sequence, blending energy, compression conditions, and in-process controls.

Patent claims must not rely solely on generic statements that the formulation is "abuse deterrent." FDA guidance expects abuse-deterrent products to demonstrate resistance to manipulation and extraction through laboratory, pharmacokinetic, and, where appropriate, human abuse-potential studies.[3]

How should an excipient strategy address opioid abuse?

A conventional immediate-release tablet is easy to crush and may be dispersed for non-oral misuse. A reformulation program can target several manipulation routes:

Abuse route	Possible formulation response
Crushing	Tough polymer matrix, high fracture resistance, elastic excipient system
Powdering	Reduced friability and controlled particle-size distribution
Water extraction	Swellable or gelling polymer system
Alcohol extraction	Solvent-resistant matrix or coating
Injection preparation	Gel formation, filtration resistance, or insoluble barrier
Nasal insufflation	Reduced powderability and limited fine-particle generation

Potential excipients include polyethylene oxide, hydroxypropyl cellulose, hypromellose, carbomers, polyvinyl alcohol, and high-viscosity polymer combinations. These materials can increase tablet size, slow dissolution, affect mouthfeel, complicate compression, and increase manufacturing cost.

An abuse-deterrent platform must preserve therapeutic performance. Excessive polymer loading may delay hydrocodone release beyond the intended immediate-release profile. The applicant must also evaluate dose dumping in alcohol, extractability in common solvents, tablet integrity, and the effects of heat, milling, and mechanical stress.

The commercial case is stronger for a product designed for institutional, managed-care, government, or high-risk prescribing channels than for a premium retail generic without formulary support.

What commercial opportunities exist for Lortab-type products?

1. Low-acetaminophen generic products

The most accessible opportunity is a competitively priced hydrocodone-acetaminophen tablet containing no more than 325 mg acetaminophen per unit. The formulation is familiar to prescribers and pharmacies, and development risk is lower than for an abuse-deterrent product.

The disadvantage is commodity pricing. The product competes against multiple generic manufacturers and faces controlled-substance quota constraints.

2. Abuse-deterrent hydrocodone-acetaminophen

An abuse-deterrent formulation could command a higher price if it receives favorable payer treatment or institutional adoption. The principal barriers are clinical development, human abuse-potential studies, extraction testing, manufacturing complexity, and FDA labeling standards.

Hydrocodone extended-release products have received abuse-deterrent attention, but a conventional immediate-release hydrocodone-acetaminophen tablet would require a product-specific development strategy. The sponsor cannot assume that an abuse-deterrent label will transfer from another hydrocodone product.

3. Smaller tablets and swallowability

A smaller tablet could address patients with dysphagia or postoperative use. The challenge is dose loading. Acetaminophen represents most of the active mass, so size reduction may require higher-density excipients, optimized granulation, or multilayer compression.

A smaller tablet could be protected through a formulation and process patent if it achieves equivalent dissolution, hardness, stability, and dose uniformity at materially reduced tablet dimensions.

4. Geriatric and institutional formulations

A unit-dose blister, calendar package, or tamper-evident institutional presentation could support hospitals, ambulatory surgery centers, and long-term-care channels. These products do not necessarily create strong drug patent protection, but packaging, workflow integration, and supply reliability may create commercial differentiation.

5. Alternative dosage forms

Oral liquids, orally disintegrating tablets, and multiparticulates may address administration needs that conventional tablets do not. They also introduce higher risks involving dosing errors, palatability, preservative systems, diversion, and controlled-substance handling.

The commercial opportunity is narrower than for tablets because hydrocodone liquid products have a higher risk of accidental pediatric exposure and measurement error.

What manufacturing and IP barriers affect a Lortab launch?

The active ingredients are established, but manufacturing is not simple.

Key technical barriers include:

• Low-dose hydrocodone uniformity within a high-dose acetaminophen blend.
• Powder segregation during transfer and compression.
• Sticking and picking caused by acetaminophen morphology.
• Tablet capping at high compression speeds.
• Lubricant sensitivity and dissolution slowdown from excess magnesium stearate.
• Hydrocodone assay and degradation-product control.
• Acetaminophen stability under moisture and heat.
• Controlled-substance inventory reconciliation.
• DEA manufacturing and procurement quotas.
• Serialization, diversion controls, and recordkeeping.
• Supplier qualification for pharmaceutical-grade excipients.

A dry-granulation process may reduce solvent exposure and simplify scale-up. Wet granulation may provide better uniformity but introduces drying, residual-moisture, and process-validation requirements. Roller compaction can improve flow and reduce segregation, but ribbon density and granule size must be controlled to avoid slow dissolution.

Packaging is part of the excipient and commercial strategy. High-barrier blister packaging can improve stability and support unit-dose control. Child-resistant bottles, tamper-evident closures, and limited-count packaging can reduce diversion and improve institutional acceptance.

What is the competitive landscape for hydrocodone-acetaminophen products?

The market includes generic manufacturers, branded or authorized generic suppliers, specialty pharmaceutical companies, and contract manufacturers. Competition is determined by:

• FDA approval status and therapeutic equivalence.
• Wholesale acquisition cost and pharmacy reimbursement.
• Reliable supply of hydrocodone API.
• DEA quota availability.
• Manufacturing capacity.
• Recall history and inspection profile.
• Formulation consistency.
• Distribution relationships.
• Payer and hospital contracting.

Biosimilar competition does not apply because Lortab is a small-molecule combination product. Generic competition is the relevant pathway.

A differentiated product may compete against conventional generics on total system value, including lower diversion risk, smaller tablets, unit-dose control, improved supply reliability, or institutional compliance. Without one of these attributes, the business is likely to remain price-sensitive.

What revenue exposure and launch scenarios exist?

Historical Lortab brand revenue is not a reliable indicator of current opportunity because the brand has been displaced by generic products and prescribing patterns have changed. Current revenue exposure depends on product positioning.

Launch scenario	Development burden	Margin potential	Principal risk
Conventional 5/325 generic tablet	Low to moderate	Low	Price erosion
Multiple strengths with standard excipients	Moderate	Low to moderate	Supply and quota management
Smaller tablet formulation	Moderate to high	Moderate	Bioequivalence and stability
Abuse-deterrent immediate-release tablet	High	Potentially high	Clinical, regulatory, and payer acceptance
Oral liquid or ODT	High	Moderate	Diversion and dosing risk
Institutional unit-dose system	Moderate	Moderate	Contracting and packaging costs

A conventional ANDA can produce the fastest market entry, but it has the weakest defensibility. A reformulated product can create stronger IP and pricing power, but only if the technical benefit is clinically and commercially visible.

What litigation and settlement issues affect Lortab?

There is no evident current brand-led patent litigation strategy comparable to an active, high-revenue protected medicine. The principal legal exposure is regulatory and compliance-related rather than patent litigation.

A new sponsor should assess:

• Orange Book listings for the selected reference product.
• Patent and exclusivity status of the current reference product.
• Paragraph IV certification exposure.
• Controlled-substance manufacturing compliance.
• Promotional claims concerning abuse deterrence.
• State opioid restrictions and prescribing limits.
• Opioid settlement obligations affecting wholesalers and pharmacies.
• Product liability associated with acetaminophen overdose and opioid misuse.

Settlement agreements are unlikely to provide material commercial value for a discontinued Lortab brand unless a specific active patent or regulatory dispute exists. The relevant diligence should focus on the actual ANDA reference product and any current litigation involving the proposed formulation or sponsor.

Key Takeaways

• Lortab is a legacy hydrocodone-acetaminophen brand, not a current patent-protected growth product.
• The U.S. market is centered on generic hydrocodone-acetaminophen tablets with no more than 325 mg acetaminophen per unit.
• The best conventional formulation platform uses robust fillers, a low-dose uniformity strategy, rapid disintegration, and controlled lubrication.
• The strongest commercial differentiation would come from abuse deterrence, reduced tablet size, improved swallowability, institutional packaging, or supply reliability.
• Biosimilar risk is irrelevant; generic competition and controlled-substance regulation determine market dynamics.
• New patents are most credible when they claim a measurable formulation or manufacturing improvement rather than routine excipient substitution.
• A standard ANDA offers speed but limited pricing power. An abuse-deterrent or specialty formulation offers greater defensibility but materially higher regulatory and development costs.

FAQs

Can a company still launch a new Lortab product?

Yes. A company can develop an approved hydrocodone-acetaminophen product using the applicable FDA generic or innovative-drug pathway. The product would compete primarily as a generic or differentiated reformulation rather than as a revived branded Lortab product.

Is acetaminophen above 325 mg per tablet commercially viable in the United States?

No. Prescription combination products containing more than 325 mg acetaminophen per dosage unit are not aligned with FDA’s current safety position and would face substantial regulatory barriers.[1]

Which excipient is best for improving hydrocodone content uniformity?

No single excipient determines uniformity. A controlled premix, geometric dilution, suitable carrier such as microcrystalline cellulose, and validated granulation or blending process are more important than a single excipient choice.

Can an abuse-deterrent Lortab formulation receive three-year exclusivity?

Potentially, if it is approved through an applicable 505(b)(2) pathway and contains a qualifying new clinical investigation essential to approval. The exclusivity analysis depends on the FDA pathway, labeling, clinical package, and product differences.

Does a new Lortab formulation need opioid-specific clinical trials?

A conventional ANDA generally relies on bioequivalence and pharmaceutical equivalence. A materially different abuse-deterrent, modified-release, or alternative dosage form may require additional clinical, pharmacokinetic, or human abuse-potential evidence.

References

1. U.S. Food and Drug Administration. (2011). FDA drug safety communication: Prescription acetaminophen products limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. https://www.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
3. U.S. Food and Drug Administration. (2015). Guidance for industry: Abuse-deterrent opioids: Evaluation and labeling. https://www.fda.gov
4. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs, NDA 018651. https://www.accessdata.fda.gov/scripts/cder/daf/
5. U.S. Drug Enforcement Administration. (n.d.). Drug scheduling and controlled substances. https://www.dea.gov-drug-information/drug-scheduling