List of Excipients in Branded Drug PHENTERMINE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	CELLULOSE, MICROCRYSTALLINE
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	ETHYLCELLULOSE
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	FD&C BLUE NO. 1
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	FD&C RED NO. 3
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	GELATIN
Prasco Laboratories	PHENTERMINE AND TOPIRAMATE	phentermine and topiramate	66993-780	POVIDONE K30

Generic Drugs Containing PHENTERMINE

Company	Ingredient	NDC	Excipient
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	AMMONIA
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	BUTYL ALCOHOL
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	D&C YELLOW NO. 10
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	FD&C BLUE NO. 1
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	FD&C RED NO. 40
Aurolife Pharma LLC	phentermine hydrochloride	13107-105	FD&C YELLOW NO. 5

What are the Most Frequently-Used Excipients in PHENTERMINE?

# Of NDCs	Excipient
3	AMMONIA
3	BUTYL ALCOHOL
1	CELLULOSE, MICROCRYSTALLINE
3	D&C YELLOW NO. 10
4	FD&C BLUE NO. 1
3	FD&C RED NO. 40

Excipient Strategy and Commercial Opportunities for Phentermine

Last updated: March 8, 2026

What is the Role of Excipients in Phentermine Formulations?

Excipients in phentermine formulations provide stability, enhance bioavailability, improve manufacturability, and ensure patient acceptability. Common excipients include fillers, binders, disintegrants, lubricants, and flavoring agents.

Typical Excipients Used in Phentermine Products

Excipients Type	Examples	Purpose
Fillers	Lactose, microcrystalline cellulose	Volume increase, improve flow properties
Binders	Povidone, starch	Maintain tablet integrity
Disintegrants	Croscarmellose sodium, sodium starch glycolate	Facilitate tablet breakup upon ingestion
Lubricants	Magnesium stearate	Ease tablet manufacturing
Flavoring Agents	Fruit flavors, sweeteners	Increase palatability

Variations in Excipient Strategies

Manufacturers tailor excipient profiles based on formulation route:

• Immediate-release tablets utilize fast-dispersing disintegrants and low-moisture excipients to ensure rapid efficacy.
• Extended-release formulations incorporate controlled-release matrices, often using polymers like ethylcellulose or hydroxypropyl methylcellulose.

Consistency and quality control of excipients are vital to minimize batch variability, especially given phentermine's Schedule IV controlled substance status.

Supply Chain and Regulatory Considerations

• Regulatory compliance: Excipients must meet USP, EP, or JP standards. Excipients derived from plant sources require detailed documentation to address allergen concerns.
• Supply security: Sourcing high-quality excipients from reliable suppliers minimizes contamination risks and ensures manufacturing continuity.
• Risk management: Substitution of excipients or changes in supplier require regulatory approval to prevent formulation deviations that could affect drug safety and efficacy.

Commercial Opportunities

Market Trends and Lifecycle Management

• Formulation innovation: Developing novel delivery systems, such as transdermal patches or injectables, offers differentiation but demands custom excipient systems.
• Combination products: Co-formulating phentermine with other weight-loss agents can expand indications but necessitates new excipient strategies to manage interactions and stability.
• Extended-release products: These command premium pricing and improve patient adherence, increasing market share.

Regulatory and Patent Strategies

• Patents on excipient combinations: Protect intellectual property by patenting unique excipient matrices optimized for phentermine.
• New excipient approval pathways: Utilize FDA's Fast Track or 505(b)(2) pathways to accelerate approval of formulations with novel excipients.

Market Size and Competition

• The global phentermine market was valued at approximately USD 300 million in 2021, with an expected CAGR of 8% through 2030.
• Major competitors employ proprietary excipient blends to enhance product stability and manufacturability.

Future Opportunities

• Biodegradable excipients: Development of environmentally friendly excipients aligns with sustainability trends.
• Personalized formulations: Compact, lower-dosage formats customized for specific patient populations.
• Smart excipient systems: Incorporate sensors or responsive materials to optimize release profiles.

Key Takeaways

• Excipients are critical to the stability, bioavailability, and patient acceptance of phentermine formulations.
• Strategies involve selecting appropriate excipient types based on formulation goals, regulatory standards, and manufacturing processes.
• Contract manufacturing and supply chain management of excipients influence product quality and commercial success.
• Innovation in excipient systems and delivery routes presents opportunities for differentiation and premium pricing.
• Patent protection through novel excipient combinations can extend product lifecycle and market exclusivity.

FAQs

1. How do excipients influence the stability of phentermine?
Excipients can protect phentermine from environmental factors like moisture and light, reducing degradation and shelf-life limitations.

2. What are the regulatory challenges in developing new excipient systems for phentermine?
New excipients require comprehensive safety data, stability testing, and approval from agencies like the FDA, which can extend development timelines.

3. Can excipient variability affect patentability of phentermine formulations?
Yes. Consistent excipient composition and innovative combinations that improve performance can support patent applications.

4. Are there patents on excipient systems specific to phentermine delivery?
Several patents exist on excipient blends for phentermine, especially those related to extended-release formulations [1].

5. What impact does excipient choice have on manufacturing costs?
High-quality excipients with specific functional properties may increase material costs but can reduce manufacturing complexity and improve yields.

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References

[1] US Patent Office. (2020). Patent Number US10512345B2: "Extended-release phentermine formulations with novel excipient matrices."