List of Excipients in Branded Drug IMIPRAMINE PAMOATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	D&C RED NO. 28
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	FD&C BLUE NO. 1
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	FD&C YELLOW NO. 6
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	GELATIN
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	MAGNESIUM STEARATE
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	METHYLPARABEN
STAT RX USA LLC	IMIPRAMINE PAMOATE	imipramine pamoate	16590-963	PROPYLPARABEN

Generic Drugs Containing IMIPRAMINE PAMOATE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	FD&C BLUE NO. 1
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	FD&C RED NO. 40
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	FD&C YELLOW NO. 6
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	FERROSOFERRIC OXIDE
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	GELATIN
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	MAGNESIUM STEARATE
Hikma Pharmaceuticals USA Inc	imipramine pamoate	0054-0273	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in IMIPRAMINE PAMOATE?

# Of NDCs	Excipient
3	FD&C BLUE NO. 1
3	FD&C RED NO. 40
3	FD&C YELLOW NO. 6
1	FERROSOFERRIC OXIDE
3	GELATIN
3	MAGNESIUM STEARATE
1	SILICON DIOXIDE

Excipient Strategy and Commercial Opportunities for Imipramine Pamoate

Last updated: February 27, 2026

What are the key excipient considerations for Imipramine Pamoate?

Imipramine pamoate, a tricyclic antidepressant in extended-release formulations, requires excipients that support stability, bioavailability, and controlled release. Critical excipients include:

• Polyvinyl acetate or methylcellulose: used as matrix formers to sustain drug release.
• Gelatin or hydroxypropyl methylcellulose (HPMC): form coating barriers to regulate dissolution.
• Microcrystalline cellulose (MCC): acts as a filler and binder.
• Magnesium stearate: functions as a lubricant during tablet manufacturing.
• Polyethylene glycol (PEG): employed for solubilizing or modifying release kinetics.

The choice impacts pharmacokinetics, shelf stability, and manufacturability.

How does excipient strategy influence manufacturing and stability?

Effective excipient selection ensures consistent drug release, reduces manufacturing variability, and enhances shelf life. For extended-release formulations, matrix or coating technologies are critical:

• Matrix systems: utilize hydrophilic polymers (HPMC) to modulate release kinetics.
• Coated beads or pellets: employ coatings like Eudragit for targeted release.

Stability considerations demand excipients inert to drug degradation, preservative compatibility, and protection against moisture or light.

What are commercial implications of excipient selection?

Selecting excipients affects:

• Manufacturing cost: cheaper, widely available excipients reduce expenses.
• Patentability: innovative excipient combinations can secure formulation patents.
• Regulatory approval: excipient choices influence review times; well-characterized excipients streamline approval.
• Market differentiation: sustained-release formulations with proprietary excipient matrices justify premium pricing.

Reformulation or novel excipient use can extend product life cycle and provide competitive advantage.

What are key patent considerations?

Patents dominate the extended-release IMIPRAMINE PAMOATE space. Patentability hinges on:

• Novel excipient combinations supporting specific release profiles.
• Unique coating or matrix application methods.
• Improved stability or reduced side effects linked to excipient formulation.

Existing patents often cover core matrices and coating formulations; innovation in excipient choice can circumvent patent expiries.

What are emerging market opportunities?

Demand for off-patent tricyclic antidepressants remains high in regions with limited healthcare funding, particularly where generics dominate. Opportunities include:

• Developing cost-effective, off-patent formulations with optimized excipients.
• Engineering formulations with improved patient compliance through taste masking or reduced dosing frequency.
• Targeting niche markets like pediatric or geriatric populations with tailored excipient profiles.

Increasing awareness of side effect profiles supports innovation to improve tolerability and adherence.

Summary table: Excipient considerations and commercial impacts

Aspect	Details	Commercial Impact
Bioavailability	Coatings and matrix for sustained release	Higher pricing, patent potential
Manufacturing	Compatibility, flow properties	Cost efficiency, scale-up ease
Stability	Inert, protective excipients	Shelf life extension, regulatory ease
Patentability	Novel combinations, application techniques	Market exclusivity
Market demand	Cost, tolerability, compliance	Revenue growth in mature markets

Key takeaways

• Excipient selection in Imipramine Pamoate influences pharmacokinetics, stability, and manufacturing.
• Controlled-release matrices and coatings are primary technologies, with choices impacting patent strategy.
• Cost, patentability, and regulatory pathways direct formulation development.
• Emerging markets present opportunities for affordable, tailored formulations.
• Innovation in excipients can extend product life cycles and support differentiability.

FAQs

1. What excipients are most common in extended-release Imipramine formulations?
   HPMC, MCC, gelatin, and PEG feature prominently for controlled release and stability.

2. Can excipient choice affect side effects?
   Yes, excipients influence drug release rates, which can impact side effect profiles and tolerability.

3. Are there patent challenges related to excipients?
   Similar active ingredients have broad patent protections; novel excipient combinations or application methods can offer patent opportunities.

4. What manufacturing challenges exist for Imipramine pamoate formulations?
   Ensuring uniform drug release, managing moisture sensitivity, and achieving batch consistency are main challenges.

5. How do excipient strategies influence market competitiveness?
   They enable differentiation through improved release profiles, stability, and patient compliance, affecting market share and pricing.

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References

[1] U.S. Food and Drug Administration. (2021). Guidance for Industry: Extended Release Oral Dosage Forms.
[2] European Medicines Agency. (2018). Reflection Paper on Quality of Modified Release Formulations.
[3] Shargel, L., & Yu, A. B.-C. (2015). Applied Biopharmaceutics & Pharmacokinetics. McGraw-Hill Education.