List of Excipients in Branded Drug AMPHETAMINE SULFATE

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Generic Drugs Containing AMPHETAMINE SULFATE

Company	Ingredient	NDC	Excipient
SpecGx LLC	amphetamine sulfate	0406-1219	CELLULOSE, MICROCRYSTALLINE
SpecGx LLC	amphetamine sulfate	0406-1219	CROSPOVIDONE
SpecGx LLC	amphetamine sulfate	0406-1219	SILICON DIOXIDE
SpecGx LLC	amphetamine sulfate	0406-1219	STEARIC ACID
Lannett Company Inc	amphetamine sulfate	0527-2524	CELLULOSE, MICROCRYSTALLINE
Lannett Company Inc	amphetamine sulfate	0527-2524	CROSPOVIDONE
Lannett Company Inc	amphetamine sulfate	0527-2524	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in AMPHETAMINE SULFATE?

# Of NDCs	Excipient
26	CELLULOSE, MICROCRYSTALLINE
27	CROSPOVIDONE
2	FD&C BLUE NO. 1
3	FD&C BLUE NO. 1 ALUMINUM LAKE
6	MAGNESIUM STEARATE
1	POVIDONE K30
1	SILICIFIED MICROCRYSTALLINE CELLULOSE

Amphetamine Sulfate Excipient Strategy, Formulation Patents, and Commercial Opportunities

Last updated: October 29, 2026

Amphetamine sulfate is an established Schedule II stimulant with low active-ingredient cost and limited protection from new chemical entity patents. Commercial value therefore depends on formulation differentiation, pediatric usability, abuse-deterrence positioning, manufacturing reliability, and regulatory execution. The strongest opportunities are orally disintegrating tablets, low-dose pediatric products, sprinkle or orally dispersible systems, taste-masked liquids, and formulations that improve dose flexibility without changing the amphetamine sulfate active ingredient.

What products contain amphetamine sulfate?

Amphetamine sulfate is marketed in immediate-release tablets and is also used in combination products containing amphetamine salts. It should not be confused with Adderall, which contains a mixture of amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate.

Product or product class	Active ingredient	Dosage form	Regulatory position
Evekeo tablets	Amphetamine sulfate	Immediate-release tablet	FDA-approved prescription product
Generic amphetamine sulfate tablets	Amphetamine sulfate	Immediate-release tablet	ANDA-based generic products
Evekeo ODT	Amphetamine sulfate	Orally disintegrating tablet	FDA-approved product
Adderall tablets	Mixed amphetamine salts	Immediate-release tablet	Different active-ingredient composition
Adderall XR	Mixed amphetamine salts	Extended-release capsule	Different active-ingredient composition
Dyanavel XR	Amphetamine hydrochloride	Extended-release oral suspension	Different salt and formulation
Mydayis	Mixed amphetamine salts	Extended-release capsule	Different active-ingredient composition

Evekeo tablets are approved for attention deficit hyperactivity disorder, narcolepsy, and short-term weight reduction in selected patients. The labeling reflects the established stimulant risks of amphetamine sulfate, including abuse, misuse, dependence, cardiovascular effects, psychiatric reactions, and growth suppression in pediatric patients (Arbor Pharmaceuticals, 2023a).

Evekeo ODT is designed to disintegrate in the mouth without water. That dosage form creates a separate excipient and process strategy from conventional compressed tablets (Arbor Pharmaceuticals, 2023b).

What excipients are used in amphetamine sulfate tablets?

Conventional amphetamine sulfate tablets generally use established, low-risk excipients for direct compression or wet granulation. Public labeling for marketed products identifies common pharmaceutical excipients such as microcrystalline cellulose, lactose, crospovidone, povidone, colloidal silicon dioxide, and magnesium stearate, although the exact qualitative and quantitative composition varies by manufacturer and dosage strength.

Excipient function	Common candidate excipients	Commercial purpose
Diluent	Lactose monohydrate, microcrystalline cellulose, mannitol	Tablet mass, compressibility, dose uniformity
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Granule strength and mechanical integrity
Disintegrant	Crospovidone, croscarmellose sodium, sodium starch glycolate	Rapid tablet breakup
Glidant	Colloidal silicon dioxide	Powder flow and content uniformity
Lubricant	Magnesium stearate, sodium stearyl fumarate	Ejection and tooling protection
Sweetener	Sucralose, aspartame, saccharin sodium	Taste masking in ODT and pediatric products
Filler for ODT	Mannitol, directly compressible sugars	Mouthfeel, cooling sensation, rapid dissolution
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, iron oxides	Identification, swallowability, light protection
Suspending agent	Xanthan gum, microcrystalline cellulose-based systems, carbomers	Physical stability in liquids
Preservative	Product-specific antimicrobial systems	Microbiological control in multidose liquids

Amphetamine sulfate is water-soluble. That property simplifies immediate-release dissolution but increases the need for taste masking in orally disintegrating and liquid products. It also creates a potential stability issue in aqueous formulations because pH, ionic strength, container closure, and preservative choice can affect chemical stability and palatability.

Which excipient strategy is best for immediate-release amphetamine sulfate tablets?

The lowest-cost strategy is a conventional immediate-release tablet using microcrystalline cellulose or lactose as the principal diluent, crospovidone as the disintegrant, colloidal silicon dioxide as the glidant, and magnesium stearate as the lubricant.

A direct-compression design is commercially attractive where the active pharmaceutical ingredient has acceptable flow and content-uniformity performance. Amphetamine sulfate is potent at relatively low doses, so blend uniformity is a central development issue. A high-dose diluent system can improve dose distribution, while geometric dilution and controlled blending reduce segregation risk.

A wet-granulation process may be preferable when the target product has:

• Low-dose content-uniformity risk
• Poor powder flow
• High friability
• Variable compression behavior
• Multiple strengths requiring a common platform

The main tradeoff is process complexity. Wet granulation adds drying, residual-moisture control, and scale-up variables. Direct compression generally offers lower manufacturing cost and fewer critical process steps.

What formulation patents could protect amphetamine sulfate products?

For an established active ingredient, protection usually comes from formulation, dosage-form, manufacturing, or method-of-use claims rather than composition-of-matter claims.

Potential patentable subject matter includes:

1. Orally disintegrating tablets with defined disintegration time, hardness, friability, and dissolution characteristics.
2. Taste-masked amphetamine sulfate particles using polymer coatings, ion-exchange resins, cyclodextrins, or lipid matrices.
3. Extended-release multiparticulates or matrix tablets.
4. Abuse-deterrent formulations that limit crushing, extraction, or rapid release.
5. Stable liquid formulations with defined pH, preservative systems, buffers, and container closures.
6. Sprinkle formulations compatible with soft food or beverages.
7. Low-dose pediatric tablets with improved content uniformity.
8. Manufacturing processes that control particle size, blend segregation, or residual solvents.
9. Fixed-dose combinations with nonstimulant ADHD agents or adjunctive therapies.
10. Packaging systems that improve dose security or reduce diversion.

The strongest formulation claims usually combine composition limitations with measurable performance requirements. A claim directed only to a familiar excipient, such as microcrystalline cellulose or magnesium stearate, is generally weak unless the formulation has a specific and unexpected technical effect.

How strong is the patent estate for amphetamine sulfate?

The underlying amphetamine sulfate molecule is old, and its basic therapeutic use is heavily exposed to prior art. The commercial patent estate is therefore likely to be narrower than the estates for newer ADHD medicines, long-acting prodrugs, or novel delivery systems.

Patent strength is highest when a product has:

• A distinctive dosage form
• A difficult-to-reproduce manufacturing process
• Clinical or pharmacokinetic differentiation
• A validated abuse-deterrence feature
• A stable liquid or ODT platform with non-obvious excipient relationships
• Multiple independent patent families covering composition, process, and use

A product relying on a conventional immediate-release tablet and routine excipient selection has limited patent durability. Regulatory exclusivity and brand recognition may provide more commercial value than the excipient patent itself.

What is the FDA regulatory status of amphetamine sulfate?

Amphetamine sulfate is a controlled prescription substance under Schedule II of the Controlled Substances Act. FDA-approved labeling carries boxed warnings concerning abuse, misuse, and addiction. Prescribers must assess cardiovascular and psychiatric risks and monitor patients for misuse and dependence (FDA, 2023).

The main FDA pathways are:

Development objective	Likely pathway
Equivalent immediate-release tablet	ANDA under section 505(j)
New ODT, liquid, or modified-release formulation	505(b)(2), depending on reliance and differences
New indication using an approved product	505(b)(2) or supplemental NDA
New combination product	505(b)(2) or NDA
Generic ODT equivalent	ANDA if an appropriate reference listed drug and bioequivalence pathway exist

For a conventional generic, the applicant must establish pharmaceutical equivalence and bioequivalence. For a novel dosage form, the sponsor may need additional studies addressing food effect, dose proportionality, alcohol interaction, in vitro release, local tolerability, and clinical usability.

When does amphetamine sulfate lose exclusivity?

Amphetamine sulfate has no meaningful remaining new chemical entity exclusivity as an active pharmaceutical ingredient. The key commercial question is whether a specific branded product has current patents, regulatory exclusivity, or product-specific barriers.

Exclusivity category	Relevance to amphetamine sulfate
New chemical entity exclusivity	Expired for this established active ingredient
Five-year orphan exclusivity	Product- and indication-specific, not inherent to the molecule
Three-year clinical investigation exclusivity	Possible for an eligible new formulation or indication
Pediatric exclusivity	Possible only if specifically awarded
180-day generic exclusivity	May apply to a first qualifying ANDA Paragraph IV applicant
Formulation patents	May remain relevant for ODT, liquid, extended-release, or abuse-deterrent products
Method-of-use patents	May cover specific patient populations or dosing regimens

Patent expiration must be assessed product by product through the FDA Orange Book and relevant patent records. The existence of amphetamine sulfate as an old active ingredient does not eliminate possible patents covering a branded formulation.

What is the Orange Book status of amphetamine sulfate products?

The Orange Book identifies reference listed drugs, approved strengths, dosage forms, patent information, and exclusivity where applicable. For an immediate-release amphetamine sulfate tablet, the main generic pathway is ordinarily an ANDA referencing the applicable listed product.

Orange Book analysis should separate:

• Amphetamine sulfate tablets
• Amphetamine sulfate orally disintegrating tablets
• Mixed amphetamine salts products
• Extended-release amphetamine products
• Products with different amphetamine salts

A generic amphetamine sulfate tablet cannot automatically rely on an Orange Book listing for Adderall, Evekeo ODT, or an amphetamine hydrochloride liquid. Salt composition, dosage form, release profile, and reference-product designation matter.

Which companies are challenging amphetamine sulfate products?

The generic market is supplied by multiple established manufacturers, depending on strength, dosage form, and current approval status. Generic competition commonly includes large U.S. and international suppliers such as Teva, Mallinckrodt, Hikma, and other ANDA holders, although market participation changes with supply conditions and manufacturing status.

For a standard immediate-release tablet, competition is primarily a price and supply-chain issue. For ODT, liquid, and modified-release products, the field is narrower because the formulation and bioequivalence requirements are more complex.

What Paragraph IV challenges are likely?

Paragraph IV litigation is most relevant when a branded product has unexpired Orange Book patents. A generic applicant may certify that listed patents are invalid, unenforceable, or not infringed. The brand sponsor can then file an infringement action, potentially triggering a 30-month stay under the Hatch-Waxman framework, subject to statutory conditions (FDA, 2024).

For a basic amphetamine sulfate tablet with no relevant unexpired listed patents, Paragraph IV risk is limited. For a branded ODT or novel delivery product, risk increases if the product has active formulation or method-of-use patents.

What formulation opportunities have the highest commercial value?

Orally disintegrating tablets

ODTs address patients who have difficulty swallowing and can improve administration in school, travel, or supervised-care settings. Key development targets include:

• Disintegration in approximately 30 seconds or less
• Low friability
• Adequate hardness for commercial handling
• Reduced bitter taste
• Minimal grittiness
• Consistent dose delivery across strengths
• Packaging protection from humidity

Mannitol-based ODT systems are attractive because they provide a clean mouthfeel and cooling sensation. Crospovidone, porous excipients, and optimized compression force can support rapid disintegration.

Taste-masked pediatric products

Amphetamine sulfate has an inherent bitter stimulant taste. Taste masking can support pediatric adherence and may allow administration in a small quantity of soft food. Coated particles, ion-exchange resins, lipid barriers, and polymeric microencapsulation are potential approaches.

The formulation must prevent premature release during oral residence while preserving rapid gastrointestinal release. Taste masking that materially delays dissolution can create bioequivalence problems.

Liquid formulations

A ready-to-use oral solution or suspension could provide flexible titration for younger children and patients requiring small dose adjustments. Commercial constraints include:

• Chemical stability in water
• Preservative effectiveness
• Dose uniformity after storage
• Container-closure compatibility
• Child-resistant packaging
• Controlled-substance security
• Taste and swallowability
• Accurate measuring-device performance

A liquid may obtain 505(b)(2) value if it provides a clinically useful administration advantage that is not available from existing tablets.

Extended-release delivery

Extended-release amphetamine sulfate would compete with established long-acting stimulant products. The opportunity is commercially significant but technically difficult. A successful product would need a differentiated pharmacokinetic profile, reduced peak-related adverse effects, durable symptom control, and a clear clinical rationale.

Generic substitution may be more difficult where the reference product has complex multiparticulate or osmotic technology. However, the development cost, clinical burden, and patent risk are substantially higher than for an immediate-release tablet.

Abuse-deterrent formulations

An abuse-deterrent formulation could use physical, chemical, or pharmacological barriers. The FDA evaluates abuse-deterrence claims under product-specific evidence and labeling standards. Deterrence against crushing or extraction does not eliminate abuse or addiction risk, and labeling claims require supporting studies (FDA, 2015).

For amphetamine sulfate, commercial value would depend on whether the product reduces a recognized misuse route without causing unacceptable loss of legitimate usability.

What manufacturing and intellectual-property barriers matter most?

The principal barriers are not the cost of amphetamine sulfate itself. They are controlled-substance compliance, reliable API sourcing, content uniformity at low dose, diversion controls, and consistent finished-product supply.

Critical manufacturing controls include:

• API identity and assay
• Particle-size distribution
• Blend uniformity
• Segregation control
• Tablet weight and hardness
• Dissolution across strengths
• Residual moisture
• Stability-indicating analytical methods
• Serialization and controlled-substance inventory reconciliation

A manufacturer can build defensible know-how around blending, granulation, compression, coating, and packaging even where patent protection is limited. Trade secrets are particularly relevant for scale-up parameters and taste-masking processes that are difficult to infer from a public patent.

How does amphetamine sulfate compare with competing ADHD products?

Attribute	Amphetamine sulfate IR	Mixed amphetamine salts IR	Long-acting amphetamine products	Methylphenidate products
Basic dosage form	Immediate-release tablet	Immediate-release tablet	Capsule, suspension, tablet, prodrug	Tablet, capsule, patch, liquid
Dose flexibility	High	High	Product-specific	Product-specific
Duration	Short	Short	Extended	Short or extended
Formulation complexity	Low to moderate	Low to high	Moderate to high	Low to high
Generic competition	High for basic tablets	High for mature products	Varies widely	High in mature products
Differentiation opportunity	ODT, liquid, taste masking	Release profile and combinations	Pharmacokinetics and delivery	Delivery system and tolerability
Patent strength	Generally limited at molecule level	Product-specific	Often stronger for delivery systems	Product-specific

Amphetamine sulfate is most competitive where clinicians value immediate dose adjustment, rapid onset, or lower-cost treatment. It is less differentiated in once-daily therapy unless paired with a novel release or administration technology.

What revenue exposure and licensing opportunities exist?

Public companies generally do not report amphetamine sulfate revenue as a standalone line item. Revenue exposure is usually embedded in broader ADHD, controlled-substance, or generic portfolios.

The most attractive licensing targets are:

• Ready-to-file ODT platforms
• Taste-masked microparticles
• Stable pediatric liquids
• Extended-release amphetamine delivery systems
• Manufacturing processes that improve content uniformity
• Abuse-deterrent technologies with stimulant applicability
• International rights for products approved in the United States

A licensing transaction should value regulatory status, clinical data, patent term, ANDA or NDA readiness, manufacturing capacity, and controlled-substance quotas. A composition patent with limited remaining term may be less valuable than a validated product with commercial-scale supply.

What generic launch scenarios exist?

Basic immediate-release tablet

The likely launch scenario is price competition among several ANDA holders. Gross margins decline as additional suppliers enter, while shortages can temporarily improve pricing power.

ODT or pediatric liquid

A smaller number of competitors may support higher net pricing. Differentiation depends on convenience, taste, dose flexibility, and payer treatment. The product must establish substitutability or a clear clinical-use advantage.

Extended-release formulation

Launch timing depends on patent certifications, litigation, regulatory review, and the complexity of the bioequivalence package. A first generic may obtain a temporary competitive advantage, but that advantage can erode after multiple approvals.

Branded reformulation

A branded reformulation can support premium pricing if it improves adherence, administration, duration, or safety-related handling. Payer restrictions remain a material risk because low-cost immediate-release amphetamine products are available.

Key Takeaways

• Amphetamine sulfate is an old, low-cost active ingredient with limited molecule-level exclusivity.
• The strongest commercial opportunities are ODTs, taste-masked pediatric products, flexible-dose liquids, and differentiated extended-release systems.
• Conventional excipients support low-cost generic tablets but rarely create strong standalone patent protection.
• Formulation claims should be linked to measurable performance, manufacturing controls, or clinical advantages.
• FDA strategy depends on whether the product is a conventional ANDA or a differentiated 505(b)(2) formulation.
• Schedule II controls, diversion risk, API sourcing, and content uniformity are major operating constraints.
• Patent and revenue analysis must distinguish amphetamine sulfate from mixed amphetamine salts and amphetamine hydrochloride products.
• Generic entry risk is high for conventional immediate-release tablets and lower for complex ODT, liquid, and extended-release products.
• Licensing value is highest where a formulation platform is technically validated and close to regulatory submission.

FAQs

Is amphetamine sulfate the same as Adderall?

No. Amphetamine sulfate is one salt used in some products. Adderall contains a mixture of four amphetamine salts, including amphetamine sulfate, amphetamine aspartate, dextroamphetamine saccharate, and dextroamphetamine sulfate.

Can excipients create patent protection for an amphetamine sulfate product?

Yes, but protection is strongest when the excipient system produces a non-obvious technical result, such as rapid disintegration, durable taste masking, improved stability, controlled release, or abuse deterrence.

Is an amphetamine sulfate liquid automatically substitutable for tablets?

No. A liquid may differ in dosage form, concentration, excipient system, labeling, stability, and regulatory status. Substitution depends on the approved product and applicable state and federal rules.

Are amphetamine sulfate ODTs easier to develop than extended-release products?

Generally, yes. ODT development usually has lower pharmacokinetic complexity than extended-release development, but taste masking, mechanical strength, humidity sensitivity, and bioequivalence remain important challenges.

What is the main commercial risk for a new amphetamine sulfate product?

The main risk is weak differentiation against low-cost generic immediate-release tablets. A new product must justify its price through administration convenience, pediatric usability, dosing flexibility, duration, supply reliability, or a credible abuse-deterrence benefit.

References

1. Arbor Pharmaceuticals, LLC. (2023a). Evekeo (amphetamine sulfate tablets) prescribing information. U.S. Food and Drug Administration.

2. Arbor Pharmaceuticals, LLC. (2023b). Evekeo ODT (amphetamine sulfate orally disintegrating tablets) prescribing information. U.S. Food and Drug Administration.

3. U.S. Food and Drug Administration. (2015). Guidance for industry: Abuse-deterrent opioids: Evaluation and labeling. FDA.

4. U.S. Food and Drug Administration. (2023). Adderall and other stimulant medicines: FDA drug safety communications and prescribing information. FDA.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

6. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP Convention.