List of Excipients in Branded Drug DEXTROAMPHETAMINE SULFATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Amneal Pharmaceuticals of New York LLC	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	0115-9927	CETYL ALCOHOL
Amneal Pharmaceuticals of New York LLC	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	0115-9927	D&C YELLOW NO. 10
Amneal Pharmaceuticals of New York LLC	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	0115-9927	DIBUTYL SEBACATE
Amneal Pharmaceuticals of New York LLC	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	0115-9927	ETHYLCELLULOSE
Amneal Pharmaceuticals of New York LLC	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	0115-9927	FD&C BLUE NO. 1

Generic Drugs Containing DEXTROAMPHETAMINE SULFATE

Company	Ingredient	NDC	Excipient
SpecGx LLC	dextroamphetamine sulfate	0406-8958	CELLULOSE, MICROCRYSTALLINE
SpecGx LLC	dextroamphetamine sulfate	0406-8958	POVIDONE
SpecGx LLC	dextroamphetamine sulfate	0406-8958	SILICON DIOXIDE
SpecGx LLC	dextroamphetamine sulfate	0406-8958	STEARIC ACID
SpecGx LLC	dextroamphetamine sulfate	0406-8960	ALCOHOL

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

# Of NDCs	Excipient
3	ALCOHOL
3	ALUMINUM OXIDE
3	AMMONIA
2	ANHYDROUS CITRIC ACID
2	BENZOIC ACID

Excipient Strategy and Commercial Opportunities for Dextroamphetamine Sulfate

Last updated: March 2, 2026

What are the key excipient considerations for Dextroamphetamine Sulfate formulations?

Dextroamphetamine sulfate medications typically require excipients that ensure stability, bioavailability, and patient compliance. Common excipients include diluents such as dibasic calcium phosphate, binders like povidone, disintegrants such as croscarmellose sodium, and lubricants including magnesium stearate. The formulation must also consider pH stability, moisture content, and ease of swallowing, especially for oral tablets and capsules.

How do excipient choices influence formulation stability and bioavailability?

Selection of excipients impacts Dextroamphetamine sulfate’s chemical stability and absorption. For instance, excipients that do not interact with the active ingredient prevent degradation. Disintegrants facilitate rapid dissolution, improving onset. Lubricants aid manufacturing but can affect bioavailability if used excessively. Formulators balance these by selecting inert excipients capable of maintaining chemical integrity over the product’s shelf life.

What are the challenges in developing extended-release formulations?

Extended-release Dextroamphetamine sulfate formulations require matrix or coating systems that control drug release without compromising stability. Excipients like hydroxypropyl methylcellulose or ethylcellulose form barriers that modulate release kinetics. Compatibility with the active ingredient and excipient interactions is critical; incompatibility can cause inconsistent drug release or stability issues.

How does excipient selection influence patentability and market exclusivity?

Novel excipient compositions and delivery mechanisms can extend patent life through formulation patents. Patents cover unique excipient combinations that enhance safety, efficacy, or ease of manufacturing. Incorporating proprietary excipients or innovative matrix systems can create market differentiation and provide barriers to generic entry.

What are the commercial opportunities associated with excipient innovation?

Innovation in excipients can enable formulation simplification, reduce manufacturing costs, improve patient compliance, or extend shelf life. Developing low-cost excipient substitutes or biodegradable matrices can improve margins. Offering excipient systems tailored for controlled release or pediatric formulations opens niche markets.

How do regulatory standards influence excipient selection?

Excipients used in Dextroamphetamine sulfate products must meet pharmacopeial standards (USP, EP, JP). Use of approved excipients simplifies regulatory approval, but novel excipients require extensive safety data. Documentation of excipient origin, purity, and stability is essential in marketing authorizations.

What are current market trends affecting excipient strategies?

Growing demand for abuse-deterrent formulations requires excipients that support tamper-resistant systems. There is also a move toward excipients derived from sustainable sources. Formulators increasingly adopt multifunctional excipients that combine disintegration, binding, and controlled-release properties.

Key market segments and opportunities:

• Generic manufacturers: Focus on cost-effective, stable, and bioavailability-enhancing excipients.
• Novel formulations: Extended-release, abuse-deterrent, pediatric, and combination products open avenues for innovative excipient use.
• Contract manufacturing: Providing specialized excipient blends and formulation development services.

Conclusion

Excipient choice significantly influences the stability, efficacy, and marketability of Dextroamphetamine sulfate formulations. Strategic development involving innovative, regulatory-compliant excipients can extend patent periods and open new market segments.

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Key Takeaways

• Excipient selection impacts formulation stability, bioavailability, and patient compliance.
• Extended-release and abuse-deterrent formulations require specific excipient systems.
• Innovation in excipients can produce significant commercial differentiation.
• Regulatory considerations regulate excipient choice, favoring approved and well-characterized substances.
• Market trends favor multifunctional and sustainable excipient options.

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FAQs

1. Which excipients are most commonly used in Dextroamphetamine sulfate tablets?
Dextroamphetamine sulfate tablets typically contain dibasic calcium phosphate (diluent), povidone (binder), croscarmellose sodium (disintegrant), and magnesium stearate (lubricant).

2. How do excipients affect abuse-deterrent formulations?
Excipients in abuse-deterrent formulations are designed to prevent misuse by making the product difficult to crush or dissolve, often using physical or chemical barriers.

3. Can novel excipients extend the patent life of Dextroamphetamine sulfate products?
Yes, incorporating unique or proprietary excipients or delivery systems can secure additional patent protection.

4. What regulatory challenges exist in formulating with new excipients?
New excipients require extensive safety data and approval processes, which can delay product launch and increase development costs.

5. Are there sustainable excipient options for Dextroamphetamine sulfate formulations?
Yes, excipients derived from renewable resources, such as plant-based polymers, are increasingly favored for sustainability and compliance with regulatory expectations.

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References

[1] U.S. Pharmacopeia. (2022). USP Monographs for Excipients.
[2] European Pharmacopoeia. (2022). Excipients standards.
[3] FDA. (2021). Guidance for Industry: Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients.
[4] Kruger, C. M., & Shea, T. (2020). Advances in Controlled-Release Drug Delivery. Journal of Pharmaceutical Sciences, 109(2), 516–534.
[5] Liu, Y., & Chua, M. (2021). Sustainable Excipients in Pharmaceutics. International Journal of Pharmaceutics, 591, 119935.